An observational study in Atrial Fibrillation, sponsored by Johnson & Johnson Medical (Shanghai) Ltd.. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Johnson & Johnson Medical (Shanghai) Ltd. · Observational
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).
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.
Exclusion criteria:
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.
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.
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.
Time frame: Day 91 to Day 365 post index procedure
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.
Time frame: Day 91 to Day 365 post index procedure
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.
Time frame: Intraoperative
Acute Reconnection
Participants with acute reconnection, which is identified by drugs challenge or pacing among all clinically relevant targeted PVs will be reported.
Time frame: Intraoperative
Repeat Ablation
Participants undergoing repeat ablation within the 12 month follow up period, including timing (blanking period or after blanking) will be reported.
Time frame: Up to 12 months post-index procedure
PV Re-Connection
Participants reporting PV re-connection during repeat ablation will be assessed and reported.
Time frame: 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.
Time frame: Baseline, up to 12 months post-index procedure
Total Procedure Time
Total procedure time will be reported.
Time frame: Intraoperative
Mapping Time
Mapping time will be reported.
Time frame: Intraoperative
Pulsed Field Ablation (PFA) Application Time
PFA application time will be reported.
Time frame: Intraoperative
Number of PFA Ablation
Number of PFA ablation will be reported.
Time frame: Intraoperative
Total Fluoroscopy Time
Total fluoroscopy time will be reported.
Time frame: Intraoperative
Study Catheter Dwell Time
Dwell time is defined as time from first Varipulse catheter insertion in LA until removal from LA.
Time frame: Intraoperative
Ablation Settings Used
The ablation parameters setting used for the procedure will be reported.
Time frame: Intraoperative
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.
Time frame: Intraoperative
Richmond Agitation-Sedation Scale Score (RASS)
RASS ranges from -5 (unarousable) to +4 (very agitated) , where 0 denotes a calm and alert patient.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Intraoperative
No study locations are listed for this record.
Plan to share: Yes — 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.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Medical (Shanghai) Ltd.