Varipulse Catheter Ablation Under Optimized Sedation for Paroxysmal Atrial Fibrillation
Looks at long-term results of Varipulse catheter ablation in adults with symptomatic paroxysmal atrial fibrillation.
Plain-language title generated from the registry record
Registry title: A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation
Key facts
- Where
- Shanghai, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07511166, who can take part
Where in China
- Zhongshan Hospital,Fudan UniversityShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Johnson & Johnson Medical (Shanghai) Ltd.
- Trial code
- NCT07511166
- Record updated
- 4 November 2026
- Original description
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).Read full original descriptionShow less
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).
Inclusion: 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: Previous left atrium (LA) ablation or surgery; Current enrollment in an investigational study evaluating another device or drug; Atrial fibrillation (AF) secondary to electrolyte imbalance, hyperthyroidism, or reversible or non-cardiac cause; 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; Left ventricular ejection fraction (LVEF) less than (<) 40 percent (%); 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; Left atrium diameter (LAD) greater than (>) 50 millimeters (mm) by transthoracic echocardiography (TTE); Known significant pulmonary vein (PV) anomaly that in the opinion of the investigator would preclude enrollment in this study; 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).