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

N/ANot Yet RecruitingNCT07511166

Johnson & Johnson Medical (Shanghai) Ltd.300 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

300

Conditions

Atrial Fibrillation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Central Contacts

YanTing Zhang

CONTACT

13162835013 yzhan365@ITS.JNJ.com

Data from ClinicalTrials.gov

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