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RECRUITING
NCT07403760
NA

Wellbeing and Survival Improvement With Event Reduction by Ablation for Atrial Fibrillation in the Very Elderly

Sponsor: Beijing Anzhen Hospital

View on ClinicalTrials.gov

Summary

The WISER-AF trial is a multicenter, double-blind, sham-controlled, randomized controlled trial. It aims to evaluate the efficacy and safety of catheter ablation compared to a sham procedure in improving the quality of life (SF-36 score) in very elderly patients (aged ≥80 years) with symptomatic atrial fibrillation over a 6-month follow-up period.

Official title: Wellbeing and Survival Improvement With Event Reduction by Ablation for Atrial Fibrillation in the Very Elderly (WISER-AF)

Key Details

Gender

All

Age Range

80 Years - Any

Study Type

INTERVENTIONAL

Enrollment

182

Start Date

2026-01-30

Completion Date

2028-12-30

Last Updated

2026-02-11

Healthy Volunteers

No

Interventions

PROCEDURE

Catheter Ablation

Patients undergo PVI (for paroxysmal AF) or PVI +linear ablation+EI-VOM(for persistent AF) using pulsed field ablation catheters. All patients will wear eye masks and headphones with music during the procedure.

PROCEDURE

Sham Control

Patients undergo femoral vein puncture and catheter placement. Phrenic nerve stimulation is performed to mimic procedural sensations. No ablation energy is delivered. All patients will wear eye masks and headphones with music during the procedure. Patients remain in the lab for at least 80 minutes.

Locations (1)

Beijing Anzhen Hospital, Capital Medical University, Beijing, China

Beijing, China