Atrial Fibrillation (AF)WISER-AFNCT07403760
Wellbeing and Survival Improvement With Event Reduction by Ablation for Atrial Fibrillation in the Very Elderly
A study testing Catheter Ablation in people with Atrial Fibrillation (AF), run by Beijing Anzhen Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Catheter Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University, Beijing, China
Beijing
Liu He, PhD., +86 13810720787, theliu@139.com
Changsheng Ma, Prof.
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Catheter Ablation, Sham Control
- Keywords
- catheter ablation, very elderly, quality of life
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter AblationProcedure or surgery
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 ControlProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Catheter Ablation Group | Experimental | Not described Receives: Procedure: Catheter Ablation |
| Sham Control Group | Sham comparator | Not described Receives: Procedure: Sham Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 months
Secondary outcomes (7)
Change in AFEQT Score
Change in Atrial Fibrillation Effect on Quality-of-Life (AFEQT) score
Measured: Baseline, 6 months
Change in Clinical Frailty Scale (CFS) Score
Change in frailty status assessed by CFS
Measured: Baseline, 6 months
Change in Left Ventricular Ejection Fraction (LVEF)
Measured: Baseline, 6 months
Change in NT-proBNP level
Measured: Baseline, 6 months
Freedom from Atrial Arrhythmias
Absence of atrial fibrillation, atrial flutter, or atrial tachycardia recorded by ECG, Holter, or patch monitor after a 30-day blanking period.
Measured: 6 months
Incidence of Composite Cardiovascular Outcome
Composite of all-cause death, stroke or systemic embolism, myocardial infarction, major bleeding, and heart failure hospitalization/emergency visits.
Measured: 6 months
Healthcare Resource Utilization
Number of emergency room visits and unplanned hospitalizations
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Changsheng Ma, Prof., Principal investigator, Beijing Anzhen HospitalNing Zhou, Prof., Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07403760
- Sponsor's protocol ID
- KS202607
- Acronym
- WISER-AF
- Status last verified
- Jun 2026
- First submitted
- 4 Feb 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wellbeing and Survival Improvement With Event Reduction by Ablation for Atrial Fibrillation in the Very Elderly (WISER-AF)
- ClinicalTrials.gov ID
- NCT07403760
- Acronym / sponsor ID
- WISER-AF / KS202607
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- catheter ablation, very elderly, quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter Ablation Group | Experimental | Procedure: Catheter Ablation |
| Sham Control Group | Sham comparator | Procedure: Sham Control |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter AblationPatients 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. | Procedure or surgery | Catheter Ablation Group |
| Sham ControlPatients 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). | Procedure or surgery | Sham Control Group |
Primary outcome
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.
7 secondary outcomes
Change in AFEQT Score
Time frame: Baseline, 6 months
Change in Clinical Frailty Scale (CFS) Score
Time frame: Baseline, 6 months
Change in Left Ventricular Ejection Fraction (LVEF)
Time frame: Baseline, 6 months
Change in NT-proBNP level
Time frame: Baseline, 6 months
Freedom from Atrial Arrhythmias
Time frame: 6 months
Incidence of Composite Cardiovascular Outcome
Time frame: 6 months
Healthcare Resource Utilization
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Changsheng Ma, Prof. principal investigator
Beijing Anzhen Hospital
Ning Zhou, Prof. principal investigator
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter Ablation in people with Atrial Fibrillation (AF), run by Beijing Anzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liu He, PhD (+86 13810720787, theliu@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SF-36 Total Score (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.