NCT03432494 is a NA clinical trial of Transcaval closure device (TCD) in Aortic Stenosis, sponsored by National Heart, Lung, and Blood Institute (NHLBI).

Who is sponsoring NCT03432494?

NCT03432494 is sponsored by National Heart, Lung, and Blood Institute (NHLBI).

What drugs are being tested in NCT03432494?

Interventions in NCT03432494: Transcaval closure device (TCD).

What condition does NCT03432494 study?

NCT03432494 studies Aortic Stenosis.

Is NCT03432494 still recruiting?

NCT03432494 is currently terminated. Last updated 14 March 2023.

Are results published for NCT03432494?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-03-14 · How we verify

NCT03432494

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement

Terminated NA Results posted Last updated 14 March 2023

What this trial tests

NA trial testing Transcaval closure device (TCD) in Aortic Stenosis in 12 participants. Terminated before completion.

Timeline

7 February 2018

Primary endpoint
30 April 2018

29 April 2019

Quick facts

Lead sponsor	National Heart, Lung, and Blood Institute (NHLBI)
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	7 February 2018
Primary completion	30 April 2018
Estimated completion	29 April 2019
Sites	3 locations across United States

Drugs / interventions tested

Transcaval closure device (TCD)

Conditions studied

Aortic Stenosis — all drugs for Aortic Stenosis →

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Who can join

21 and older, any sex, with Aortic Stenosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Technical Success of Delivery of the Transcaval Closure Device (TCD) Primary · 1 minute following procedure discharge (Exit from the catheterization laboratory)

Number of participants with technical success of delivery of the transcaval closure device (TCD) All of the following must be present for technical success: 1. Alive 2. Successful delivery of the TCD, and retrieval of the TCD delivery system 3. Deployment and correct positioning of a single intended TCD. Repositioning and recapture of the device, if needed, is not classified as failure. 4. No additional unplanned or emergency surgery or re-intervention related to the TCD or delivery system 5. Adjunctive balloon aortic tamponade is permissible and consistent with technical success

Group	Value	95% CI
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	12

Number of Participants With Closure Success of the Transcaval Closure Device (TCD) Secondary · 1 minute following procedure discharge (Exit from the catheterization laboratory)

Number of Participants With Technical Closure Success of Delivery of the Transcaval Closure Device (TCD). This secondary endpoint is a composite of the primary endpoint and hemostasis of the transcaval aortic access site. All of the following must be present for Closure Success: 1. Alive 2. Successful delivery of the TCD, and retrieval of the TCD delivery system 3. Deployment and correct positioning of a single intended TCD. Repositioning and recapture of the device, if needed, is not classified as failure. 4. No additional unplanned or emergency surgery or re-intervention related to the TCD

Group	Value	95% CI
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	9

Number of Participants Who Experienced Device Success of the Transcaval Closure Device (TCD) Secondary · 30 days and 12 Months

A key performance endpoint is the number of participants who experienced device success of the transcaval closure device (TCD). All of the following must be present for device success: 1. Alive or Death unrelated to transcaval access or TAVR 2. Original intended TCD in place 3. No additional surgical or interventional procedures related to access or the device after exit from the cath lab Intended performance of the TCD, including all of: 1. Structural Performance: No migration, embolization, detachment, fracture, hemolysis, or endarteritis related to the TCD 2. Hemodynamic performance: No

30 Days

Group	Value	95% CI
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	12

12 Months

Group	Value	95% CI
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	10

Number of Participants That Experienced Procedural Success Secondary · 30 Days

Number of participants that experienced safety endpoint of procedural success following transcaval closure device (TCD) at day 30. All of the following must be present for procedural success: 1. Device success 2. No device-related Serious Adverse Events, defined as VARC-2 life-threatening bleeding, major vascular or cardiac complications related to the TCD requiring unplanned reintervention or surgery (such as covered stent implantation at the transcaval access site)

Group	Value	95% CI
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	12

Number of Participants Requiring Covered Stent Implantation as a Normal Provisional Part of the Procedure Secondary · During procedure, procedure may last from 2 to 4 hours

Number of participants requiring covered stent implantation as a normal provisional part of the procedure assessed during the procedure.

Group	Value	95% CI
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	0

Number of Participants With Covered Stent Implantation at the Transcaval Closure Device Implantation Site Secondary · During procedure, procedure may last from 2 to 4 hours

Number of participants with covered stent implantation at the transcaval closure device (TCD) implantation site

Group	Value	95% CI
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	0

Number of Participants Final Acute Aorto-caval Fistula Score Secondary · 30 Days

Number of Participants final acute aorto-caval fistula score at procedure completion. Scoring is defined as: Type 0=occlusion, Type 1=patent fistula, Type 2=cruci-form fistula pattern, Type 3=extravasation. A score of 0 is associated with complete occlusion at the transcaval closure device (TCD) site while a higher score is associated with incomplete occlusion at the TCD site.

Group	Value	95% CI
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	9
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	1
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	2
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	0

Number of Participants Who Experienced Modified Valve Academic Research Consortium-2 Vascular Complications Secondary · 30 days

Participants who experienced Minor or Major modified Valve Academic Research Consortium-2 (VARC-2) vascular complications. Major is defined as: Aortic dissection or aortic rupture; Access site-related arterial or venous injury THAT RESULTS IN death, hemodynamic compromise, life-threatening, extensive; or major bleeding, visceral ischemia, neurological impairment; Distal embolization requiring surgery or resulting in amputation or irreversible end-organ damage; severe access site vascular complication Minor is defined as: Access site-related arterial or venous injury THAT DOES NOT RESULT IN de

Major : Unrelated to Transcaval Closure Device

Group	Value	95% CI
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	0

Major : At Least Possibly Related to Transcaval Closure Device

Group	Value	95% CI
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	0

Minor Unrelated to Transcaval Closure Device : Unrelated to Transcaval Closure Device

Group	Value	95% CI
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	1

Minor Unrelated to Transcaval Closure Device: At Least Possibly Related to Transcaval Closure Device

Group	Value	95% CI
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	1

Number of Participants Who Experienced Modified Valve Academic Research Consortium-2 Bleeding Complications Secondary · 30 Days

Number of Participants Who Experienced Major or Life-threatening Modified Valve Academic Research Consortium-2 (VARC-2) bleeding complications at 30 days Major defined as: Corrected drop in the hemoglobin of \>=3.0 g/dl AND does not meet criteria of life-threatening or extensive bleeding; Requiring transfusion of \>=3 U of whole blood or packed RBCs AND does not meet criteria of life-threatening or extensive bleeding. Life-threatening defined as: Intracranial requiring surgery or intervention; Intraspinal requiring surgery or intervention; Intraocular requiring surgery or intervention; Peric

Life-threatening : Unrelated to Transcaval Closure Device

Group	Value	95% CI
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	0

Life-threatening : At least Possibly Related to Transcaval Closure Device

Group	Value	95% CI
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	0

Major : Unrelated to Transcaval Closure Device

Group	Value	95% CI
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	1

Major : At least Possibly Related to Transcaval Closure Device

Group	Value	95% CI
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	0

Number of Participants Who Experienced Major Adverse Cardiovascular Events Secondary · Day 30

Number of Participants Who Experienced Major Adverse Cardiovascular Events (MACE) Major adverse cardiovascular events (MACE), defined as VARC-2 Early Safety composite: No mortality, stroke, life-threatening bleeding, acute kidney injury (AKI) stage 2+, major vascular complication, and valve-related complication.

Stroke : Unrelated to Transcaval Closure Device

Group	Value	95% CI
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	2

Stroke : At least possibly related to Transcaval Closure Device

Group	Value	95% CI
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	0

Myocardial Infraction : Unrelated to Transcaval Closure Device

Group	Value	95% CI
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	1

Myocardial Infraction : At least possibly related to Transcaval Closure Device

Group	Value	95% CI
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	0

Acute Kidney Injury (Stage II or III) : Unrelated to Transcaval Closure Device

Group	Value	95% CI
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	0

Acute Kidney Injury (Stage II or III) : At least possibly related to Transcaval Closure Device

Group	Value	95% CI
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	0

Number of Participants With Closure Success of Delivery of the Transcaval Closure Device (TCD) Secondary · 30 Days and 12 Months

Number of Participants With Closure Success of Delivery of the Transcaval Closure Device (TCD). All of the following must be present for Closure Success: 1. Alive or Death unrelated to transcaval access or TAVR 2. Successful delivery of the TCD, and retrieval of the TCD delivery system 3. Deployment and correct positioning of a single intended TCD. Repositioning and recapture of the device, if needed, is not classified as failure. 4. No additional unplanned or emergency surgery or re-intervention related to the TCD or delivery system. Adjunctive balloon aortic tamponade is permissible and co

30 Days

Group	Value	95% CI
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	12

12 Months

Group	Value	95% CI
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	10

All-Cause Mortality Secondary · 30 Days

All-cause mortality, as categorized by cardiovascular vs non-cardiovascular, peri- vs non-periprocedural, regardless of attribution to Transcaval Closure Device (TCD)

Cardiovascular Deaths : Unrelated to Transcaval Closure Device

Group	Value	95% CI
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	0

Cardiovascular Deaths : At least possibly related to Transcaval Closure Device

Group	Value	95% CI
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	0

Non-Cardiovascular Deaths : Unrelated to Transcaval Closure Device

Group	Value	95% CI
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	1

Non-Cardiovascular Deaths : At least possibly related to Transcaval Closure Device

Group	Value	95% CI
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article

Serious: 9/12 (75%)

Deaths: 1/12

Serious adverse events (21 terms)

Reaction	System	Transcaval Access and Clos…
Heart failure	Cardiac disorders	—
Stroke	Nervous system disorders	—
Anemia	Blood and lymphatic system disorders	—
Atrioventricular block complete	Cardiac disorders	—
Cardiac Chest pain	Cardiac disorders	—
Mobitz (type) II atrioventricular block	Cardiac disorders	—
Myocardial infarction	Cardiac disorders	—
Bronchial infection	Infections and infestations	—
C. Difficile infection	Infections and infestations	—
Fall	Injury, poisoning and procedural complications	—
Cardiac troponin I increased	Investigations	—
Creatinine increased	Investigations	—
Chest wall pain	Musculoskeletal and connective tissue disorders	—
Dysarthria	Nervous system disorders	—
Transient ischemic attacks	Nervous system disorders	—
Aspiration	Respiratory, thoracic and mediastinal disorders	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—
Shortness of Breath	Respiratory, thoracic and mediastinal disorders	—
Arterial thromboembolism	Vascular disorders	—
Labile blood pressure	Vascular disorders	—

Other adverse events (41 terms — click to expand)

Reaction	System	Transcaval Access and Clos…
Anemia	Blood and lymphatic system disorders	—
Cardiac troponin I increased	Investigations	—
Blood lactate dehydrogenase increased	Investigations	—
Leukocytosis	Blood and lymphatic system disorders	—
Platelet count decreased	Investigations	—
Hypoalbuminemia	Metabolism and nutrition disorders	—
Creatinine increased	Investigations	—
Elevated BNP	Investigations	—
Cardiac Chest pain	Cardiac disorders	—
Haptoglobin decreased	Investigations	—
Hemolysis	Blood and lymphatic system disorders	—
Aortic valve disease	Cardiac disorders	—
Atrial fibrillation	Cardiac disorders	—
Mild AVR paravalvular leak	Cardiac disorders	—
Moderate PV aortic regurgitation	Cardiac disorders	—
Conduction disorder	Cardiac disorders	—
Heart failure	Cardiac disorders	—
Right ventricular dysfunction	Cardiac disorders	—
Diarrhea	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
Edema limbs	General disorders	—
Fever	General disorders	—
Fall	Injury, poisoning and procedural complications	—
Left femoral hematoma	Injury, poisoning and procedural complications	—
Right groin oozing	Injury, poisoning and procedural complications	—
Small right groin hematoma	Injury, poisoning and procedural complications	—
Head laceration with fall	Injury, poisoning and procedural complications	—
Aspartate aminotransferase increased	Investigations	—
Elevated BUN	Investigations	—
Elevated Haptoglobin	Investigations	—
Hypernatremia	Metabolism and nutrition disorders	—
Generalized muscle weakness	Musculoskeletal and connective tissue disorders	—
Headache	Nervous system disorders	—
Delirium	Psychiatric disorders	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—
Pulmonary edema	Respiratory, thoracic and mediastinal disorders	—
In-situ squamous cell carcinoma lesion on right dorsal forearm.	Skin and subcutaneous tissue disorders	—
Arterial thromboembolism	Vascular disorders	—
Hypertension	Vascular disorders	—
Hypotension	Vascular disorders	—

Most-reported serious reactions: Heart failure, Stroke, Anemia, Atrioventricular block complete, Cardiac Chest pain, Mobitz (type) II atrioventricular block, Myocardial infarction, Bronchial infection.

Data from ClinicalTrials.gov NCT03432494 adverse events section.

Sponsor's own description

Background: Transcatheter aortic valve replacement (TAVR) is a non-surgical alternative to standard surgical aortic valve replacement. Not all patients are eligible for TAVR using standard access through the artery in the groin, because the artery is too small or too diseased. In this study, TAVR is performed using a new technique called transcaval access. The catheter is placed in the artery deep in the body by crossing through the wall of a deep vein. The connection between that vein and the aorta is closed with a new metallic device they are testing. This is called a transcaval closure device (TCD). Objective: To test the safety and early feasibility of closure of transcaval aortic access sites using the TCD after TAVR. Eligibility: Adults ages 21 and older undergoing TAVR for whom the procedure cannot be performed safely by the standard artery approach Design: Participants will be assessed by heart experts including cardiologists and surgeons. Participants will have TAVR by the transcaval approach. A small catheter will be passed between the largest vein in the body and the nearby largest artery (aorta), inside the abdomen. Through this catheter, the TAVR will be implanted in the usual way. After, doctors will implant the TCD by catheter to close the hole made in the aorta. Participants will be X-rayed. A dye will be injected to view the TCD device. Participants will get standard TAVR care afterwards. They will have physical exams, blood tests, and scans. Participants will have a follow-up scan within 1 month and after 12 months. Participants will have follow-up visits and phone calls 6 and 12 months after the procedure.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

The Fate of Transcaval Access Tracts: 12-Month Results of the Prospective NHLBI Transcaval Transcatheter Aortic Valve Replacement Study.
Lederman RJ, Babaliaros VC, Rogers T, Stine AM, et al · · 2019 · cited 49× · PMID 30846083 · DOI 10.1016/j.jcin.2018.11.035
Dedicated Closure Device for Transcaval Access Closure: From Concept to First-in-Human Testing.
Rogers T, Greenbaum AB, Babaliaros VC, Stine AM, et al · · 2019 · cited 12× · PMID 31629746 · DOI 10.1016/j.jcin.2019.05.053

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03432494 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI)
Last refreshed: 14 March 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03432494.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing