A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation

NCT07511166 | Not Yet Recruiting

• 1 other identifier: BWI202523
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main purpose of the study is to assess how well the standard ablation procedure (Varipulse Catheter) works over long term when used with different types of anesthesia in participants with symptomatic paroxysmal atrial fibrillation (PAF, irregular heartbeat that comes and goes on its own, causing noticeable symptoms like a racing heart, or shortness of breath).

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias Episode

  Participants reporting freedom from documented (asymptomatic and symptomatic) atrial tachyarrhythmias (atrial fibrillation \[AF\], atrial tachycardia \[AT\] or atrial flutter \[AFL\] of unknown origin) episode based on 24-hour Holter will be reported. Additionally, criteria for effectiveness failure included following: 1) Greater (\>) than 1 repeat ablations for AF, AT, and AFL of unknown origin in the blanking period or any repeat ablation or surgical treatment for AF, AT, and AFL of unknown origin; 2) Direct current or pharmacological cardioversion for AF, AT, and AFL of unknown origin and; 3) A Class I and/or Class III antiarrhythmic drugs (AAD) is prescribed for AF, AT, and AFL of unknown origin.

  Day 91 to Day 365 post index procedure

Secondary Outcomes (14)

• Acute Procedural Success

  Intraoperative

• Acute Reconnection

  Intraoperative

• Repeat Ablation

  Up to 12 months post-index procedure

• PV Re-Connection

  Up to 12 months post-index procedure

• Pain Visual Analogue Scale (VAS) Score

  Prior to Discharge (up to Day 1 post-index procedure)

Study Arms (2)

General Anesthesia Group

Participants undergoing ablation for treatment of symptomatic Paroxysmal Atrial Fibrillation (PAF) under general anesthesia will undergo pulsed field ablation (PFA) with Varipulse PFA catheter system including Varipulse catheter and Trupulse generator.

Non-General Anesthesia Group

Participants undergoing ablation for treatment of symptomatic PAF under the non-general anesthesia, including participants with deep sedation and conscious sedation will undergo PFA with the Varipulse PFA catheter system including Varipulse catheter and Trupulse generator.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include participants diagnosed with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF) or who are intolerable to class I and/or III antiarrhythmic drugs (AAD) based on medical records.

You may qualify if:

• Diagnosed with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF) or intolerable to class I and/or III antiarrhythmic drugs (AAD) based on medical records
• Age 18-80 years
• Able and willing to comply with all pre-procedure, post-procedure, and follow-up testing and visit requirements
• Signed patient informed consent form (ICF)

You may not qualify if:

• Atrial fibrillation (AF) secondary to electrolyte imbalance, hyperthyroidism, or reversible or non-cardiac cause
• Previous left atrium (LA) ablation or surgery
• Left atrium diameter (LAD) greater than (\>) 50 millimeters (mm) by transthoracic echocardiography (TTE)
• Left ventricular ejection fraction (LVEF) less than (\<) 40 percent (%)
• Known significant pulmonary vein (PV) anomaly that in the opinion of the investigator would preclude enrollment in this study
• Current enrollment in an investigational study evaluating another device or drug
• Women who are pregnant (as evidenced by pregnancy test or oral confirmation if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation
• Life expectancy less than 12 months
• Presenting contra-indications for the devices used in the study, as indicated in the respective instructions for use (IFU)
• Presenting contra-indications for catheter ablation at physicians' discretion, for example LA/Left atrial appendage (LAA) thrombus, systematic infection, situations preventing catheter access
• Other conditions that, at discretion of the investigators, would preclude enrollment in this study

Sponsors & Collaborators

• Johnson & Johnson Medical (Shanghai) Ltd.: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Johnson & Johnson Medical (Shanghai) Ltd. Clinical Trial

  Johnson & Johnson Medical (Shanghai) Ltd.

  STUDY DIRECTOR

Central Study Contacts

YanTing Zhang

CONTACT

13162835013; yzhan365@ITS.JNJ.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 6, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): February 9, 2028
• Study Completion (Estimated): March 28, 2028
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share