High-quality Pulmonary Veins Isolation Using Varipulse Catheter Under Contact and Continuity Guidance in Patients With Paroxysmal Atrial Fibrillation Under Optimized Sedation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 300
- Primary Endpoint
- Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias Episode
Study Overview
Brief 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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Acute Procedural Success(Intraoperative)
- Acute Reconnection(Intraoperative)
- Repeat Ablation(Up to 12 months post-index procedure)
- Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Questionnaire Score(Baseline, up to 12 months post-index procedure)
- Total Procedure Time(Intraoperative)
- Mapping Time(Intraoperative)
- Pulsed Field Ablation (PFA) Application Time(Intraoperative)
- Number of PFA Ablation(Intraoperative)
- Total Fluoroscopy Time(Intraoperative)
- Study Catheter Dwell Time(Intraoperative)
- Ablation Settings Used(Intraoperative)
- Use of Paralytics and Anesthesia, and Related Drug Details(Intraoperative)
- PV Re-Connection(Up to 12 months post-index procedure)
- Pain Visual Analogue Scale (VAS) Score(Prior to Discharge (up to Day 1 post-index procedure))
- Freedom From Documented (Symptomatic and Asymptomatic) AF, AT, and AFL(Day 91 to Day 365 post index procedure)
- Participant Electrophysiology (EP) Lab Time(Intraoperative)
- Richmond Agitation-Sedation Scale Score (RASS)(Intraoperative)
- Participant's Movements During Ablation(Intraoperative)
- Percentage of Participants who Switch from Non-General Anesthesia (GA) to GA(Intraoperative)