An observational study in Atrial Fibrillation, sponsored by Johnson & Johnson Medical (Shanghai) Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Johnson & Johnson Medical (Shanghai) Ltd. (part of Johnson & Johnson) · 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).
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 300 is close to the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Johnson & Johnson Medical (Shanghai) Ltd. is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Data sharing details ↗ · www.jnj.com
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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