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

High-quality Pulmonary Veins Isolation Using Varipulse Catheter Under Contact and Continuity Guidance in Patients With Paroxysmal Atrial Fibrillation Under Optimized Sedation

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: YanTing Zhang; Phone Number: +86 13162835013; Email: yzhan365@ITS.JNJ.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion criteria:

• Diagnosed with I and/or III antiarrhythmic drugs (AAD)-refractory symptomatic paroxysmal atrial fibrillation (PAF) or intolerable to class I and/or III 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)

Exclusion criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Procedural Success	Acute procedural success, which is defined as confirmation of entrance block in all clinically relevant targeted pulmonary vein (PVs) after drugs challenge or pacing at the end of the index ablation procedure will be reported.	Intraoperative
Acute Reconnection	Participants with acute reconnection, which is identified by drugs challenge or pacing among all clinically relevant targeted PVs will be reported.	Intraoperative
Repeat Ablation	Participants undergoing repeat ablation within the 12 month follow up period, including timing (blanking period or after blanking) will be reported.	Up to 12 months post-index procedure
Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Questionnaire Score	The AFEQT uses a questionnaire to evaluate symptoms, daily activities and treatment concerns participants have related to atrial fibrillation. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" difficult to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). A positive change in score corresponds to improvement in AF symptoms.	Baseline, up to 12 months post-index procedure
Total Procedure Time	Total procedure time will be reported.	Intraoperative
Mapping Time	Mapping time will be reported.	Intraoperative
Pulsed Field Ablation (PFA) Application Time	PFA application time will be reported.	Intraoperative
Number of PFA Ablation	Number of PFA ablation will be reported.	Intraoperative
Total Fluoroscopy Time	Total fluoroscopy time will be reported.	Intraoperative
Study Catheter Dwell Time	Dwell time is defined as time from first Varipulse catheter insertion in LA until removal from LA.	Intraoperative
Ablation Settings Used	The ablation parameters setting used for the procedure will be reported.	Intraoperative
Use of Paralytics and Anesthesia, and Related Drug Details	Number of participants reporting the use of paralytics and anesthesia, and related drug details will be reported.	Intraoperative
Freedom From Documented (Symptomatic and Asymptomatic) AF, AT, and AFL	Participants reporting freedom from documented (asymptomatic and symptomatic) atrial tachyarrhythmias (AF, AT or AFL of unknown origin) lasting >= 30 seconds based on mobile electrocardiogram (ECG) during the effectiveness evaluation period will be reported.	Day 91 to Day 365 post index procedure
PV Re-Connection	Participants reporting PV re-connection during repeat ablation will be assessed and reported.	Up to 12 months post-index procedure
Participant Electrophysiology (EP) Lab Time	Participant EP lab time is defined as the time taken for participant on table to leave table, including induction and awakening.	Intraoperative
Richmond Agitation-Sedation Scale Score (RASS)	RASS ranges from -5 (unarousable) to +4 (very agitated) , where 0 denotes a calm and alert patient.	Intraoperative
Pain Visual Analogue Scale (VAS) Score	VAS score will be measured for intraprocedural pain, discomfort and anxiety and post-procedural groin pain, throat pain and chest pain prior to hospital discharge using 100- point VAS, where 0 = no pain/anxiety/comfort, 100 = worst imaginable pain/anxiety/discomfort. Higher score means greater severity.	Prior to Discharge (up to Day 1 post-index procedure)
Participant's Movements During Ablation	Participant's significant movements causing map shifting or CARTO "learning new" warning, and coughs will be reported. Phrenic nerve stimulation not included.	Intraoperative
Percentage of Participants who Switch from Non-General Anesthesia (GA) to GA	Percentage of participants who need to switch from non-GA to GA will be reported.	Intraoperative

Collaborators and Investigators

• Sponsor: Johnson & Johnson Medical (Shanghai) Ltd.
• Investigators: Study Director: Johnson & Johnson Medical (Shanghai) Ltd. Clinical Trial, Johnson & Johnson Medical (Shanghai) Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): September 7, 2026
• Primary Completion (Estimated): July 28, 2028
• Study Completion (Estimated): July 28, 2028

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): August 28, 2026
• Last Update Submitted That Met QC Criteria: August 27, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: BWI202523

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of Johnson & Johnson MedTech is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No