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

Sponsor
Beijing Anzhen Hospital
Study ID
NCT07403760
Status
Recruiting
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Conditions

  • Atrial Fibrillation (AF)

Eligibility Criteria

Sex
ALL
Age
80 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Catheter Ablation — PROCEDURE
    Patients undergo PVI (for paroxysmal AF) or PVI +linear ablation+EI-VOM(for persistent AF). All patients will wear eye masks and headphones with music during the procedure.
  • Sham Control — PROCEDURE
    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 60 minutes (for paroxysmal AF) or 90 minutes (for persistent AF).

Study Details

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.

Key Dates

First listed
Feb 11, 2026
Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Nov 30, 2028
Completion
Dec 30, 2028

Study Design

Enrollment
136 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Catheter Ablation Group
  • Sham Comparator: Sham Control Group

Primary Outcome Measure

Change in SF-36 Total Score [ Time Frame: Baseline, 6 months ]

Central Contacts

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