Atrial FibrillationGreatPFANCT07511166
A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation
An observational study of Atrial Fibrillation, run by Johnson & Johnson Medical (Shanghai) Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 12 Oct 2026to 28 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital Fudan University
Shanghai, 200032
About this study
Official title: 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).
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 91 to Day 365 post index procedure
Secondary outcomes (19)
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.
Measured: 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.
Measured: Intraoperative
Acute Reconnection
Participants with acute reconnection, which is identified by drugs challenge or pacing among all clinically relevant targeted PVs will be reported.
Measured: Intraoperative
Repeat Ablation
Participants undergoing repeat ablation within the 12 month follow up period, including timing (blanking period or after blanking) will be reported.
Measured: Up to 12 months post-index procedure
PV Re-Connection
Participants reporting PV re-connection during repeat ablation will be assessed and reported.
Measured: 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.
Measured: Baseline, up to 12 months post-index procedure
Total Procedure Time
Total procedure time will be reported.
Measured: Intraoperative
Mapping Time
Mapping time will be reported.
Measured: Intraoperative
Pulsed Field Ablation (PFA) Application Time
PFA application time will be reported.
Measured: Intraoperative
Number of PFA Ablation
Number of PFA ablation will be reported.
Measured: Intraoperative
Total Fluoroscopy Time
Total fluoroscopy time will be reported.
Measured: Intraoperative
Study Catheter Dwell Time
Dwell time is defined as time from first Varipulse catheter insertion in LA until removal from LA.
Measured: Intraoperative
Ablation Settings Used
The ablation parameters setting used for the procedure will be reported.
Measured: 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.
Measured: Intraoperative
Richmond Agitation-Sedation Scale Score (RASS)
RASS ranges from -5 (unarousable) to +4 (very agitated) , where 0 denotes a calm and alert patient.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start12 Oct 2026 (estimated)
- Primary completion28 Jul 2028 (estimated)
- Study completion28 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Medical (Shanghai) Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Medical (Shanghai) Ltd. Clinical Trial, Study director, Johnson & Johnson Medical (Shanghai) Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511166
- Sponsor's protocol ID
- BWI202523
- Other IDs
- BWI202523
- Acronym
- GreatPFA
- Status last verified
- Nov 2026
- First submitted
- 30 Mar 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-quality Pulmonary Veins Isolation Using Varipulse Catheter Under Contact and Continuity Guidance in Patients With Paroxysmal Atrial Fibrillation Under Optimized Sedation
- ClinicalTrials.gov ID
- NCT07511166
- Acronym / sponsor ID
- GreatPFA / BWI202523
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Johnson & Johnson Medical (Shanghai) Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Oct 2026 (estimated)
- Primary completion
- 28 Jul 2028 (estimated)
- Study completion
- 28 Jul 2028 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias Episode
Time frame: Day 91 to Day 365 post index procedure
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.
19 secondary outcomes
Freedom From Documented (Symptomatic and Asymptomatic) AF, AT, and AFL
Time frame: Day 91 to Day 365 post index procedure
Acute Procedural Success
Time frame: Intraoperative
Acute Reconnection
Time frame: Intraoperative
Repeat Ablation
Time frame: Up to 12 months post-index procedure
PV Re-Connection
Time frame: Up to 12 months post-index procedure
Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Questionnaire Score
Time frame: Baseline, up to 12 months post-index procedure
Total Procedure Time
Time frame: Intraoperative
Mapping Time
Time frame: Intraoperative
Pulsed Field Ablation (PFA) Application Time
Time frame: Intraoperative
Number of PFA Ablation
Time frame: Intraoperative
Total Fluoroscopy Time
Time frame: Intraoperative
Study Catheter Dwell Time
Time frame: Intraoperative
Ablation Settings Used
Time frame: Intraoperative
Participant Electrophysiology (EP) Lab Time
Time frame: Intraoperative
Richmond Agitation-Sedation Scale Score (RASS)
Time frame: Intraoperative
Pain Visual Analogue Scale (VAS) Score
Time frame: Prior to Discharge (up to Day 1 post-index procedure)
Participant's Movements During Ablation
Time frame: Intraoperative
Percentage of Participants who Switch from Non-General Anesthesia (GA) to GA
Time frame: Intraoperative
Use of Paralytics and Anesthesia, and Related Drug Details
Time frame: Intraoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: 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.
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Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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CONVERGE Post-Approval Study (PAS)
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johnson & Johnson Medical (Shanghai) Ltd. Clinical Trial study director
Johnson & Johnson Medical (Shanghai) Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Johnson & Johnson Medical (Shanghai) Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YanTing Zhang (13162835013 ext. +86, yzhan365@ITS.JNJ.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias Episode (time frame: Day 91 to Day 365 post index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.