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Recruiting Observational

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

NCT07511166 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2026-10-12
Last updated
2026-11-04

Condition(s) studied

Atrial Fibrillation

Study 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 symptoms like a racing heart, or shortness of breath).

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion criteria: * 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 criteria: * 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 * 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

Primary outcome measure(s)

  • Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias Episode — 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.

Trial sites (1)

FacilityCityRegionStatus
Zhongshan Hospital Fudan University Shanghai China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07511166 on ClinicalTrials.gov ↗ ← All trials in China