Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:50 AM
Study NCT ID:
NCT07403760
Status:
RECRUITING
Last Update Posted:
2026-02-11
First Post:
2026-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wellbeing and Survival Improvement With Event Reduction by Ablation for Atrial Fibrillation in the Very Elderly
Sponsor:
Beijing Anzhen Hospital
Organization:
Study Overview
Official Title:
Wellbeing and Survival Improvement With Event Reduction by Ablation for Atrial Fibrillation in the Very Elderly (WISER-AF)
Status:
RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WISER-AF
Brief 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.
Detailed Description:
Atrial fibrillation (AF) prevalence increases with age, posing significant challenges in the very elderly (≥80 years). While catheter ablation is an established treatment for general AF patients, its efficacy in improving quality of life (QoL) in the very elderly remains underrepresented in previous trials. The WISER-AF trial is designed to fill this evidence gap. The study will enroll 182 symptomatic AF patients aged ≥80 years in China. Patients will be randomized 1:1 to undergo either pulsed field ablation (PFA) or a sham procedure. To ensure blinding, all patients will wear eye masks and headphones during the procedure. The sham group will receive phrenic nerve stimulation to mimic the sensation of ablation without delivering therapeutic energy. The primary endpoint is the change in the SF-36 total score from baseline to 6 months. Secondary endpoints include changes in AFEQT score, Clinical Frailty Scale (CFS), LVEF, NT-proBNP, 6-minute walk distance, and cardiovascular events.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: