Who is sponsoring NCT05970120?

NCT05970120 is sponsored by Biosense Webster, Inc..

What drugs are being tested in NCT05970120?

Interventions in NCT05970120: NUVISION NAV Ultrasound Catheter.

What condition does NCT05970120 study?

NCT05970120 studies Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Ventricular Tachycardia, Premature Ventricular Complex.

Is NCT05970120 still recruiting?

NCT05970120 is currently completed. Last updated 20 May 2025.

Are results published for NCT05970120?

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

Last reviewed 2025-05-20 · How we verify

NCT05970120

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

A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter

Completed NA Results posted Last updated 20 May 2025

What this trial tests

NA trial testing NUVISION NAV Ultrasound Catheter in Scar-related Atrial Tachycardia in 30 participants. Completed in 22 February 2024.

Timeline

5 September 2023

Primary endpoint
22 February 2024

22 February 2024

Quick facts

Lead sponsor	Biosense Webster, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	5 September 2023
Primary completion	22 February 2024
Estimated completion	22 February 2024
Sites	3 locations across Italy, Croatia, Israel

Drugs / interventions tested

NUVISION NAV Ultrasound Catheter

Conditions studied

Scar-related Atrial Tachycardia — all drugs for Scar-related Atrial Tachycardia →
Persistent Atrial Fibrillation — all drugs for Persistent Atrial Fibrillation →
Paroxysmal Atrial Fibrillation — all drugs for Paroxysmal Atrial Fibrillation →
Ventricular Tachycardia — all drugs for Ventricular Tachycardia →

Sponsor

Biosense Webster, Inc. — full company profile →

Who can join

18 and older, any sex, with Scar-related Atrial Tachycardia or Persistent Atrial Fibrillation. 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.

Percentage of Participants With Completion of Imaging With the NUVISION NAV Ultrasound Catheter Without Resort to Non-study Mapping Catheter Primary · At Day 1

Percentage of participants with completion of imaging with the NUVISION NAV ultrasound catheter without resort to non-study mapping catheter were reported.

Group	Value	95% CI
NUVISION NAV Ultrasound Catheter	100.0	88.4 – 100.0

Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the NUVISION NAV Ultrasound Catheter Primary · From day of index procedure (Day 1) up to 7 days

Number of participants with SAEs within 7 days of index procedure related to the NUVISION NAV ultrasound catheter were reported. An AE was any untoward medical experience (sign, symptom, illness, abnormal laboratory value, or other medical event) occurring to a participant during the course of the study whether or not related to the investigational device. SAE was any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, was life-threatening experience, a congenital anomaly/birth defect and ma

Group	Value	95% CI
NUVISION NAV Ultrasound Catheter	0

Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures Secondary · Day 1

Physician assessment of deployment, maneuverability and navigational features with the NUVISION NAV ultrasound catheter during the study procedures were reported. The physician's feedback was collected after each study procedure for each investigational catheter through a questionnaire-based survey consisting of 15 question/sub-question. Each survey question/sub-question included a response option with a Likert scale of 1 to 7 (1=poor and 7=excellent). A score of 4 on the Likert scales indicated the catheter met expectations or was comparable to other devices. Scores of greater than or equal t

Initial catheter introduction insert catheter into sheath

Group	Value	95% CI
NUVISION NAV Ultrasound Catheter	7.0	6.0 – 7.0

Advance catheter into heart

Group	Value	95% CI
NUVISION NAV Ultrasound Catheter	7.0	6.0 – 7.0

Visualize catheter on fluoroscopy

Group	Value	95% CI
NUVISION NAV Ultrasound Catheter	7.0	6.0 – 7.0

Catheter performance assessment deflection control

Group	Value	95% CI
NUVISION NAV Ultrasound Catheter	7.0	6.0 – 7.0

Deflection reach

Group	Value	95% CI
NUVISION NAV Ultrasound Catheter	6.5	5.0 – 7.0

Deflection degree (bi-directional)

Group	Value	95% CI
NUVISION NAV Ultrasound Catheter	7.0	5.0 – 7.0

Torqability

Group	Value	95% CI
NUVISION NAV Ultrasound Catheter	7.0	6.0 – 7.0

Ability to maintain torque

Group	Value	95% CI
NUVISION NAV Ultrasound Catheter	7.0	6.0 – 7.0

Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures Secondary · Day 1

Physician assessment of imaging quality acquired with the NUVISION NAV ultrasound catheter during the study procedures was reported. The quality of image acquired with NUVISION NAV ultrasound catheter and displayed by CARTO software was assessed through physician's feedback on 11 question/sub-questions. Each survey question/sub-question included a response option with a Likert scale of 1 to 7 (1=poor and 7=excellent). A score of 4 on the Likert scales indicated the catheter met expectations or was comparable to other devices. Scores of \>=4 were considered satisfaction.

Contouring, value of drawing CARTOSOUND contours on 2D ultrasound image

Group	Value	95% CI
NUVISION NAV Ultrasound Catheter	7.0	5.0 – 7.0

On dual-plane

Group	Value	95% CI
NUVISION NAV Ultrasound Catheter	6.0	5.0 – 7.0

On multi-plane

Group	Value	95% CI
NUVISION NAV Ultrasound Catheter	6.0	5.0 – 7.0

General did CARTO integration help you to orient in multi-plane?

Group	Value	95% CI
NUVISION NAV Ultrasound Catheter	6.0	4.0 – 7.0

Did CARTO integration help you to orient in 4D?

Group	Value	95% CI
NUVISION NAV Ultrasound Catheter	6.0	4.0 – 7.0

Did image on CARTO screen change as predicted when deflecting in anterior and posterior directions?

Group	Value	95% CI
NUVISION NAV Ultrasound Catheter	6.0	5.0 – 7.0

How useful was the 'store clip' on CARTO?

Group	Value	95% CI
NUVISION NAV Ultrasound Catheter	6.0	4.0 – 7.0

Was troubleshooting information provided by the system helpful?

Group	Value	95% CI
NUVISION NAV Ultrasound Catheter	6.0	5.0 – 7.0

Physicians Overall Feedback on the NUVISION NAV Ultrasound Catheter During the Study Procedures Secondary · Day 1

Physicians overall feedback on the NUVISION NAV ultrasound catheter during the study procedure was reported. The overall feedback on the NUVISION NAV ultrasound catheter was assessed through physician's feedback on 3 question/sub-questions. Each survey question/sub-question included a response option with a Likert scale of 1 to 7 (1=poor and 7=excellent). A score of 4 on the Likert scales indicated the catheter met expectations or was comparable to other devices. Scores of \>=4 were considered satisfaction. TEE is transesophageal echocardiography.

Do you think that the NUVISION NAV ultrasound catheter is an acceptable alternative to TEE?

Group	Value	95% CI
NUVISION NAV Ultrasound Catheter	7.0	6.0 – 7.0

What is your overall satisfaction of the NUVISION NAV ultrasound catheter?

Group	Value	95% CI
NUVISION NAV Ultrasound Catheter	7.0	6.0 – 7.0

Would you recommend the NUVISION NAV ultrasound catheter to fellow physicians?

Group	Value	95% CI
NUVISION NAV Ultrasound Catheter	7.0	4.0 – 7.0

Number of Serious Adverse Events (SAEs) Excluding NUVISION NAV Ultrasound Catheter Related SAE Within 7 Days of Index Procedure Secondary · From day of index procedure (Day 1) up to 7 days

Number of SAEs excluding NUVISION NAV ultrasound catheter related SAE within 7 days of index procedure was reported. AE was any untoward medical experience (sign, symptom, illness, abnormal laboratory value, or other medical event) occurring to a participant during the course of the study whether or not related to the investigational device. SAE was any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, was life-threatening experience, a congenital anomaly/birth defect and may jeopardize pa

Group	Value	95% CI
NUVISION NAV Ultrasound Catheter	2	0.8 – 22.1

Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Related to the NUVISION NAV Ultrasound Catheter Secondary · From day of index procedure (Day 1) up to 7 days

Number of participants with non-serious adverse events within 7 days of index procedure related to the NUVISION NAV ultrasound catheter were reported. AE was any untoward medical experience (sign, symptom, illness, abnormal laboratory value, or other medical event) occurring to a participant during the course of the study whether or not related to the investigational device.

Group	Value	95% CI
NUVISION NAV Ultrasound Catheter	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From baseline up to 7 days after index procedure on Day 1. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

NUVISION NAV Ultrasound Catheter

Serious: 2/30 (7%)

Deaths: 0/30

Serious adverse events (2 terms)

Reaction	System	NUVISION NAV Ultrasound Ca…
Complete Atrioventricular block	Cardiac disorders	—
Vascular access site pseudoaneurysm	Injury, poisoning and procedural complications	—

Other adverse events (2 terms — click to expand)

Reaction	System	NUVISION NAV Ultrasound Ca…
Pericardial Effusion	Cardiac disorders	—
Delayed Wound Healing	Injury, poisoning and procedural complications	—

Most-reported serious reactions: Complete Atrioventricular block, Vascular access site pseudoaneurysm.

Data from ClinicalTrials.gov NCT05970120 adverse events section.

Sponsor's own description

The purpose of this study is to assess the performance and safety of using the investigational catheter.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Scar-related Atrial Tachycardia

Currently open trials in the same condition.

NCT07116525 — A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter · NA · recruiting

Other Biosense Webster, Inc. trials

Trials by the same sponsor.

NCT07527299 — A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior · NA · not yet recruiting
NCT07523750 — A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants Wit · NA · not yet recruiting
NCT07429214 — A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF · NA · recruiting
NCT07428564 — A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE PRO Software in Participants With PsAF · NA · not yet recruiting
NCT07227532 — A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Cathe · 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 NCT05970120 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Biosense Webster, Inc.
Last refreshed: 20 May 2025

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/NCT05970120.

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