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

Sponsor
Johnson & Johnson Medical (Shanghai) Ltd.
Study ID
NCT07511166
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Study Details

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).

Key Dates

First listed
Apr 6, 2026
Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Feb 9, 2028
Completion
Mar 28, 2028

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias Episode [ Time Frame: Day 91 to Day 365 post index procedure ]

Central Contacts

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