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NCT07511166Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 25 Sept 2026

Brief summary (registry, in English)

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).

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
300 (estimated)
First submitted
30 Mar 2026
Start date
12 Oct 2026
Primary completion date
28 Jul 2028
Lead sponsor
Johnson & Johnson Medical (Shanghai) Ltd.
NCT number
NCT07511166

What you commit to

  • Study type: Observational
  • Planned participants: 300
  • From 12 Oct 2026 to the primary completion date, 28 Jul 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous left atrium (LA) ablation or surgery
  • Current enrollment in an investigational study evaluating another device or drug

Other illness

  • 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

Lab values

  • Left ventricular ejection fraction (LVEF) less than (\<) 40 percent (%)

Age

  • 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

Other

  • 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)

Who the study is looking for

  • 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)

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.