Who is sponsoring NCT01118299?

NCT01118299 is sponsored by Abbott Medical Devices.

What drugs are being tested in NCT01118299?

Interventions in NCT01118299: AMPLATZER Cardiac Plug.

What condition does NCT01118299 study?

NCT01118299 studies Atrial Fibrillation, Ischemic Stroke, Peripheral Thromboembolism.

Is NCT01118299 still recruiting?

NCT01118299 is currently completed. Last updated 14 April 2020.

Are results published for NCT01118299?

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

Last reviewed 2020-04-14 · How we verify

NCT01118299

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

AMPLATZER Cardiac Plug Clinical Trial

Completed NA Results posted Last updated 14 April 2020

What this trial tests

NA trial testing AMPLATZER Cardiac Plug in Atrial Fibrillation in 97 participants. Completed in 6 December 2018.

Timeline

26 April 2010

Primary endpoint
6 December 2018

6 December 2018

Quick facts

Lead sponsor	Abbott Medical Devices
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	97
Start date	26 April 2010
Primary completion	6 December 2018
Estimated completion	6 December 2018
Sites	18 locations across United States

Drugs / interventions tested

AMPLATZER Cardiac Plug

Conditions studied

Atrial Fibrillation — all drugs for Atrial Fibrillation →
Ischemic Stroke — all drugs for Ischemic Stroke →
Peripheral Thromboembolism — all drugs for Peripheral Thromboembolism →

Sponsor

Abbott Medical Devices — full company profile →

Who can join

18 and older, any sex, with Atrial Fibrillation or Ischemic Stroke. 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.

Acute Safety - Procedure Related SAEs From Randomization Through Discharge For Device Arm Only Primary · From Randomization to Discharge Visit

An analysis comparing the rate of procedure related serious adverse events that occur in the device arm to a performance goal determined from literature reported rates for similar procedural techniques. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT). However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints.

Device Embolization

Group	Value	95% CI
Device Arm	3

Pleural Effusion

Group	Value	95% CI
Device Arm	1

Hematoma

Group	Value	95% CI
Device Arm	1

Pericardial Tamponade

Group	Value	95% CI
Device Arm	3

Cardiac Perforation*

Group	Value	95% CI
Device Arm	1

Pericardial Effusion

Group	Value	95% CI
Device Arm	1

Cardiogenic Shock*

Group	Value	95% CI
Device Arm	1

Pericarditis*

Group	Value	95% CI
Device Arm	1

Long-term Safety - Device Arm Only Primary · Randomization to 2 year follow-up

All-Cause Mortality and Major Bleeds Through 2 years in device arm subjects only. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT). However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated Septe

Empyema (Major Bleeding)

Group	Value	95% CI
Device Arm	1

Hemothorax (Major Bleeding)

Group	Value	95% CI
Device Arm	1

Hematoma (Major Bleeidng)

Group	Value	95% CI
Device Arm	1

Bleeding (Major Bleeding)

Group	Value	95% CI
Device Arm	1

Respiratory Failure (Death)

Group	Value	95% CI
Device Arm	2

Congestive Heart Failure (Death)

Group	Value	95% CI
Device Arm	1

Device Embolization (Death)

Group	Value	95% CI
Device Arm	1

Effectiveness Endpoint - Device Arm Only Primary · Randomization through 2 year follow up

Occurrence of ischemic stroke and peripheral thromboembolism in the device arm. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT). However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated Septemb

Ischemic Stroke

Group	Value	95% CI
Device Arm	2

Peripheral Thromboembolism

Group	Value	95% CI
Device Arm	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 5 Years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Device

Serious: 52/68 (76%)

Deaths: 7/68

Optimal Medical Therapy (Control)

Serious: 15/29 (52%)

Deaths: 5/29

Serious adverse events (103 terms)

Reaction	System	Device	Optimal Medical Therapy (C…
Atrial Fibrillation	Cardiac disorders	—	—
Congestive Heart Failure	Cardiac disorders	—	—
Pericardial Effusion	Cardiac disorders	—	—
Chest Pain	Cardiac disorders	—	—
Device Embolization	Cardiac disorders	—	—
Pericardial Tamponade	Cardiac disorders	—	—
Pneumonia	Cardiac disorders	—	—
Bacterial Infections	Cardiac disorders	—	—
Persistent Atrial Fibrillation	Cardiac disorders	—	—
Pleural Effusion	Cardiac disorders	—	—
Respiratory Failure	Cardiac disorders	—	—
Sepsis	Cardiac disorders	—	—
VASC Hematoma	Cardiac disorders	—	—
Acute Bronchitis	Cardiac disorders	—	—
Acute Pancreatitis	Cardiac disorders	—	—
Acute Renal Failure	Cardiac disorders	—	—
Atrial Tachycardia	Cardiac disorders	—	—
Cancer	Cardiac disorders	—	—
Cholecystitis	Cardiac disorders	—	—
Chronic Obstructive Pulmonary Disease (COPD)	Cardiac disorders	—	—
Dysphagia	Cardiac disorders	—	—
Elective Surgery	Cardiac disorders	—	—
Hematoma	Cardiac disorders	—	—
Ischemic Stroke	Cardiac disorders	—	—
Myocardial Infarction	Cardiac disorders	—	—

Other adverse events (182 terms — click to expand)

Reaction	System	Device	Optimal Medical Therapy (C…
VASC Bleeding	Cardiac disorders	—	—
Edema	Cardiac disorders	—	—
Hypotension	Cardiac disorders	—	—
Dyspnea	Cardiac disorders	—	—
Residual Interatrial Communication	Cardiac disorders	—	—
VASC Hematoma	Cardiac disorders	—	—
Atrial Fibrillation	Cardiac disorders	—	—
Fall	Cardiac disorders	—	—
Urinary Tract Infections	Cardiac disorders	—	—
Bleeding	Cardiac disorders	—	—
Bruise/Purpura Simplex	Cardiac disorders	—	—
Numbness	Cardiac disorders	—	—
Palpitations	Cardiac disorders	—	—
Pericardial Effusion	Cardiac disorders	—	—
Sore Throat	Cardiac disorders	—	—
Acute Bronchitis	Cardiac disorders	—	—
Common Cold/Upper Respiratory Tract Infection	Cardiac disorders	—	—
Shingles	Cardiac disorders	—	—
Abnormal Lab Value	Cardiac disorders	—	—
Asymptomatic Ischemic Stroke	Cardiac disorders	—	—
Atelectasis	Cardiac disorders	—	—
Chest Pain	Cardiac disorders	—	—
Chronic Obstructive Pulmonary Disease (COPD)	Cardiac disorders	—	—
Depression	Cardiac disorders	—	—
Dizziness	Cardiac disorders	—	—
Dysphagia	Cardiac disorders	—	—
Fatigue/Generalized Fatigue	Cardiac disorders	—	—
Pain	Cardiac disorders	—	—
Pneumonia	Cardiac disorders	—	—
Urinary Retention	Cardiac disorders	—	—
VASC Bruise	Cardiac disorders	—	—
Abrasion	Cardiac disorders	—	—
Acute Renal Failure	Cardiac disorders	—	—
Aortic Aneurysms	Cardiac disorders	—	—
Arm Fracture	Cardiac disorders	—	—
Atrial Flutter	Cardiac disorders	—	—
Back Pain	Cardiac disorders	—	—
Bronchitis	Cardiac disorders	—	—
Cellulitis	Cardiac disorders	—	—
Drug Side Effect	Cardiac disorders	—	—

Most-reported serious reactions: Atrial Fibrillation, Congestive Heart Failure, Pericardial Effusion, Chest Pain, Device Embolization, Pericardial Tamponade, Pneumonia, Bacterial Infections.

Data from ClinicalTrials.gov NCT01118299 adverse events section.

Sponsor's own description

The objective of this study is to evaluate the safety and effectiveness of the ACP in subjects with nonvalvular atrial fibrillation by demonstrating that the device is non-inferior to optimal medical therapy (OMT) with respect to the primary effectiveness endpoint and superior to OMT with respect to primary safety endpoint.

Publications & conference data

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

Left atrial appendage closure to prevent stroke in patients with atrial fibrillation.
Price MJ, Valderrábano M. · · 2014 · cited 23× · PMID 25001625 · DOI 10.1161/circulationaha.114.009060
Left atrial appendage exclusion for atrial fibrillation.
Syed FF, DeSimone CV, Friedman PA, Asirvatham SJ. · · 2014 · cited 12× · PMID 25443240 · DOI 10.1016/j.ccl.2014.07.006
Left atrial appendage exclusion for stroke prevention in atrial fibrillation.
Patel TK, Yancy CW, Knight BP. · · 2012 · cited 9× · PMID 23119222 · DOI 10.1155/2012/610827
Optimization Of Stroke Prophylaxis Strategies In Nonvalvular AF -Drugs, Devices Or Both?
Noheria A, Syed FF, DeSimone CV, Asirvatham SJ. · · 2015 · PMID 27957183 · DOI 10.4022/jafib.1156

Verify or expand the search:

Other recruiting trials for Atrial Fibrillation

Currently open trials in the same condition.

NCT07429214 — A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF · NA · recruiting
NCT07271238 — Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures · NA · recruiting
NCT07388108 — Atrial Dyssynchrony to Predict Arrhythmias in the Postoperative Setting of Cardiovascular Surgery. · recruiting
NCT07428967 — AV Node Ablation and CONDUCTion System Pacing for Atrial Fibrillation With Preserved Left Ventricular Function · NA · recruiting
NCT06650995 — AlEX-DHF: Ablation and Exercise in Diastolic Heart Failure · NA · recruiting

Other Abbott Medical Devices trials

Trials by the same sponsor.

NCT07421076 — Grid eXplore Mapping Study · NA · recruiting
NCT07509658 — TriClip Japan Post-Approval Study · recruiting
NCT07361445 — Agilis RF TSP Early Feasibility Study · NA · recruiting
NCT07373353 — A Clinical Evaluation of AMJ-401 · NA · recruiting
NCT07217392 — Left Bundle Branch Area Pacing (LBBAP) PMCF Study · NA · recruiting

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 NCT01118299 (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 Abbott Medical Devices
Last refreshed: 14 April 2020

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/NCT01118299.

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