Wellbeing and Survival Improvement With Event Reduction b... | NCT07403760

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

NCT07403760

Sponsor

Beijing Anzhen Hospital

Status

Recruiting

Last Update Posted

Jul 6, 2026Actual

Enrollment

136Estimated

Phase

Not Applicable

Conditions

Atrial Fibrillation (AF)

Interventions

Catheter Ablation
Sham Control

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2026Estimated

Primary Completion Date

Nov 30, 2028Estimated

Completion Date

Dec 30, 2028Estimated

First Submitted Date

Feb 4, 2026

First Submission Date that Met QC Criteria

Feb 4, 2026

First Posted Date

Feb 11, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2026

Last Update Posted Date

Jul 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 136 symptomatic AF patients aged ≥80 years in China. Patients will be randomized 1:1 to undergo either catheter ablation 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, and cardiovascular events.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

136Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Catheter Ablation Group	Experimental		Procedure: Catheter Ablation
Sham Control Group	Sham Comparator		Procedure: Sham Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Change in AFEQT Score	Change in Atrial Fibrillation Effect on Quality-of-Life (AFEQT) score	Baseline, 6 months
Change in Clinical Frailty Scale (CFS) Score	Change in frailty status assessed by CFS

Other Outcomes

Measure	Description	Time Frame
Safety Outcome	Composite of all-cause death, stroke, serious adverse events and complications	6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

80 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Liu He, PhD	Contact	+86 13810720787		theliu@139.com

Overall Officials

Name	Affiliation	Role
Changsheng Ma, Prof.	Beijing Anzhen Hospital	Principal Investigator
Ning Zhou, Prof.	Beijing Anzhen Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Anzhen Hospital, Capital Medical University, Beijing, China	Recruiting	Beijing			China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017115	Catheter Ablation

Ancestor Terms

ID	Term
D000078703	Radiofrequency Ablation
D000078702	Radiofrequency Therapy
D013812	Therapeutics
D055011	Ablation Techniques

Browse Leaves

Not provided

Browse Branches

Not provided