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Not yet recruiting NCT07511166

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

— Observational Atrial Fibrillation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Atrial Fibrillation. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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).

Primary outcome measures

  • Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias Episode [Time frame: Day 91 to Day 365 post index procedure]
Secondary outcome measures (12)
  • Freedom From Documented (Symptomatic and Asymptomatic) AF, AT, and AFL [Time frame: Day 91 to Day 365 post index procedure]
  • Acute Procedural Success [Time frame: Intraoperative]
  • Acute Reconnection [Time frame: Intraoperative]
  • Repeat Ablation [Time frame: Up to 12 months post-index procedure]
  • PV Re-Connection [Time frame: Up to 12 months post-index procedure]
  • Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Questionnaire Score [Time frame: Baseline, up to 12 months post-index procedure]
  • Total Procedure Time [Time frame: Intraoperative]
  • Mapping Time [Time frame: Intraoperative]
  • Pulsed Field Ablation (PFA) Application Time [Time frame: Intraoperative]
  • Number of PFA Ablation [Time frame: Intraoperative]
  • Total Fluoroscopy Time [Time frame: Intraoperative]
  • Study Catheter Dwell Time [Time frame: Intraoperative]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07511166 · BWI202523

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗