A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System

The purpose of this study is to evaluate the long-term safety and effectiveness of the FDA approved VARIPULSE catheter system for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF).

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Phoenix Cardiovascular Research Group, Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Symptomatic paroxysmal Atrial Fibrillation (AF) who, in the opinion of the investigator, are candidates for catheter ablation for AF
Refractory (that is, ineffective, not tolerated, or not desired) or contraindicated to at least one Class I/III antiarrhythmic drugs (AAD)
Willing and capable of providing consent
Able and willing to comply with all pre-, post-, and follow-up testing and requirements

Exclusion criteria

Previously diagnosed with persistent or long-standing persistent AF (more than [>] 7 days in duration)
Previous surgical or catheter ablation for AF
Significant congenital anomaly or medical problem that in the opinion of the investigator would be a contraindication to catheter ablation for AF
Current enrollment in an investigational study evaluating another device or drug
Life expectancy less than 12 months
Any contraindications as defined in the Protocol

Treatment and study plan

Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator

Device

Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator will be used.

Primary outcomes

Occurences of Early Onset Primary Adverse Events (PAEs) Within 7 days of the Index Ablation Procedure

Time frame: Within 7 days post index procedure

PAE's will include the following adverse events: atrio-esophageal fistula, phrenic nerve paralysis, cardiac tamponade/perforation, pulmonary vein stenosis (PVS), device or procedure related death, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency), and vagal nerve injury/gastroparesis.
Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias Episodes

Time frame: Day 61-1095 post-index procedure

Freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmias (atrial fibrillation [AF], atrial tachycardia [AT] or atrial flutter [AFL] of unknown origin) episodes will be reported. AFL of unknown origin is defined as all AFL except those Cavotricuspid isthmus CTI dependent AFL as confirmed by 12-Lead electrocardiogram (ECG) and entrainment maneuvers in an evaluation period study.

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Purcell

CONTACT

[email protected]

+1 949 230 3701

Sponsors and collaborators

Lead sponsor

Biosense Webster, Inc.

Industry

Registry information

Official study title

BWI202405: Assessment of Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the VARIPULSE™ Catheter System

Acronym: AdmIREPAS

Important dates

Study start: 2025
Primary completion: 2030
Study completion: 2030
First posted: Nov 12, 2025
Registry last updated: Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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