A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System (AdmIREPAS)

Biosense Webster

Status: Enrolling

Conditions: Atrial Fibrillation

Treatments: Device: Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator

Study type: Interventional

Funder types: Industry

Identifiers

NCT07227532

BWI202405 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the long-term safety and effectiveness of the VARIPULSE catheter system for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF).

Enrollment: 276 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatic paroxysmal Atrial Fibrillation (AF) who, in the opinion of the investigator, are candidates for catheter ablation for AF
• Refractory, intolerant, or contraindicated to Class I/III antiarrhythmic drugs (AAD)
• Willing and capable of providing consent
• Able and willing to comply with all pre-, post-, and follow-up testing and requirements

Exclusion criteria

• Previously diagnosed with persistent or long-standing persistent AF (more than [>] 7 days in duration)
• Previous surgical or catheter ablation for AF
• Significant congenital anomaly or medical problem that in the opinion of the investigator would be a contraindication to catheter ablation for AF
• Current enrollment in an investigational study evaluating another device or drug
• Life expectancy less than 12 months
• Any contraindications as defined in the Protocol

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

276 participants in 1 patient group

Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator

Experimental group

Description:

Participants undergoing electrophysiology mapping and pulsed field ablation (PFA) for management of treatment of symptomatic paroxysmal atrial fibrillation (AF) will undergo pulmonary vein (PV) ablation with the VARIPULSE Catheter with a TRUPULSE Generator.

Treatment:

Device: Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator