NCT07403760

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Jan 2026Dec 2028

Study Start

First participant enrolled

January 30, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2028

Last Updated

February 11, 2026

Status Verified

January 1, 2026

Enrollment Period

2.8 years

First QC Date

February 4, 2026

Last Update Submit

February 4, 2026

Conditions

Atrial Fibrillation (AF)

Keywords

catheter ablationvery elderlyquality of life

Outcome Measures

Primary Outcomes (1)

  • Change in SF-36 Total Score

    Difference in the change of the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) total score from baseline to 6 months between the two groups.

    Baseline, 6 months

Secondary Outcomes (9)

  • Change in AFEQT Score

    Baseline, 6 months

  • Change in Clinical Frailty Scale (CFS) Score

    Baseline, 6 months

  • Change in Left Ventricular Ejection Fraction (LVEF)

    Baseline, 6 months

  • Change in NT-proBNP level

    Baseline, 6 months

  • Change in 6-Minute Walk Distance (6MWT)

    Baseline, 6 months

  • +4 more secondary outcomes

Study Arms (2)

Catheter Ablation Group

EXPERIMENTAL
Procedure: Catheter Ablation

Sham Control Group

SHAM COMPARATOR
Procedure: Sham Control

Interventions

Catheter AblationPROCEDURE

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.

Catheter Ablation Group
Sham ControlPROCEDURE

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.

Sham Control Group

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age ≥ 80 years.
  • Documented paroxysmal or persistent atrial fibrillation by ECG or Holter within 6 months prior to enrollment.
  • Symptomatic AF (including palpitations, chest tightness, fatigue, dizziness, blackouts, dyspnea).
  • Voluntary participation and signed informed consent.

You may not qualify if:

  • NYHA Class IV heart failure.
  • Acute myocardial infarction, cardiac surgery, or PCI within the past 1 year.
  • Long-standing persistent AF (duration \> 1 year).
  • Left atrial anteroposterior diameter \> 6 cm.
  • History of prior AF ablation.
  • AF secondary to reversible causes (e.g., post-surgery, infection, hyperthyroidism).
  • Severe mitral stenosis.
  • Moderate to severe hepatic failure (Child-Pugh B-C).
  • Renal failure stage 4-5 (eGFR \<30 ml/min/1.73m2) or continuous dialysis.
  • Inability to cooperate due to dementia or severe mental disorder.
  • Presence of left atrial thrombus.
  • Prior Left Atrial Appendage Occlusion (LAAO).
  • Contraindication to anticoagulation.
  • Life expectancy \< 1 year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University, Beijing, China

Beijing, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Changsheng Ma, Prof.

    Beijing Anzhen Hospital

    PRINCIPAL INVESTIGATOR

  • Ning Zhou, Prof.

    Beijing Anzhen Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu He, PhD

CONTACT

+86 13810720787theliu@139.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2026

First Posted

February 11, 2026

Study Start

January 30, 2026

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

December 30, 2028

Last Updated

February 11, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)