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

July 1, 2026 updated by: Beijing Anzhen Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
136

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Liu He, PhD
  • Phone Number: +86 13810720787
  • Email: theliu@139.com

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Anzhen Hospital, Capital Medical University, Beijing, China
        • Contact:
        • Principal Investigator:
          • Changsheng Ma, Prof.
        • Principal Investigator:
          • Ning Zhou, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Sham Control Group
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 60 minutes (for paroxysmal AF) or 90 minutes (for persistent AF).
Experimental: Catheter Ablation Group
Procedure: Catheter Ablation
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in SF-36 Total Score
Time Frame: Baseline, 6 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in AFEQT Score
Time Frame: Baseline, 6 months
Change in Atrial Fibrillation Effect on Quality-of-Life (AFEQT) score
Baseline, 6 months
Change in Clinical Frailty Scale (CFS) Score
Time Frame: Baseline, 6 months
Change in frailty status assessed by CFS
Baseline, 6 months
Change in Left Ventricular Ejection Fraction (LVEF)
Time Frame: Baseline, 6 months
Baseline, 6 months
Change in NT-proBNP level
Time Frame: Baseline, 6 months
Baseline, 6 months
Freedom from Atrial Arrhythmias
Time Frame: 6 months
Absence of atrial fibrillation, atrial flutter, or atrial tachycardia recorded by ECG, Holter, or patch monitor after a 30-day blanking period.
6 months
Incidence of Composite Cardiovascular Outcome
Time Frame: 6 months
Composite of all-cause death, stroke or systemic embolism, myocardial infarction, major bleeding, and heart failure hospitalization/emergency visits.
6 months
Healthcare Resource Utilization
Time Frame: 6 months
Number of emergency room visits and unplanned hospitalizations
6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety Outcome
Time Frame: 6 months
Composite of all-cause death, stroke, serious adverse events and complications
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Anzhen Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Changsheng Ma, Prof., Beijing Anzhen Hospital
  • Principal Investigator: Ning Zhou, Prof., Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KS202607

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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