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AzTrials

Atrial Fibrillation (AF)ELEVATE-AFNCT06883864

Efficacy and Safety of Catheter abLation in patiEnts With seVere mitrAl regurgiTation and pErsistent Atrial Fibrillation: a Randomized Controlled Trial

A study testing Catheter ablation plus medication, Medication and (ELEVATE-AF X) experimental group in people with Atrial Fibrillation (AF) and Catheter Ablation, run by Beijing Anzhen Hospital at 17 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Atrial fibrillation (AF) leads to atrial functional mitral regurgitation (MR) through mechanisms including mitral annular dilatation, systolic leaflet motion distance alteration, and contractility decrease. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Catheter ablation plus medication, Medication and (ELEVATE-AF X) experimental group
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
17 sitesChina
Study dates
8 Apr 2025to 1 May 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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients were required to have moderate-to-severe or greater (≥3+) atrial functional mitral regurgitation assessed by transthoracic echocardiography within 14 days before randomization. Mitral regurgitation severity was graded by an echocardiography core-lab based on the American Society of Echocardiography criteria, specifically an effective regurgitant orifice area (EROA) ≥30 mm²
  • Age 18-80 years
  • Persistent atrial fibrillation diagnosed by electrocardiogram
  • Left ventricular ejection fraction ≥50% assessed by transthoracic echocardiography within 14 days before randomization(confirmed by the echocardiography core-lab)
  • Left ventricular end-diastolic internal diameter ≤60 mm and left atrial anterior- posterior diameter ≤60 mm in echocardiographic parasternal long-axis view within 14 days before randomization(confirmed by the echocardiography core-lab)
  • Agree to undergo catheter ablation and be able to undergo follow-up as required.

Who cannot join

  • paroxysmal atrial fibrillation, atrial fibrillation secondary to an apparently reversible cause, or with history of previous ablation;
  • primary mitral valve pathology, including calcification, sclerosis, prolapse, flail, tendon cable rupture, valve degeneration, infective endocarditis, rheumatic lesions, or ischemic lesions;
  • history of previous mitral valve surgery or transcatheter manipulation;
  • mitral valve orifice area <4 cm2;
  • aortic valve disease requiring surgical or transcatheter intervention;
  • untreated clinically significant coronary artery disease requiring revascularization;
Show all 26Show fewer
  • history of previous myocardial infarction;
  • previous definitive diagnosis of cardiomyopathies such as dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, arrhythmogenic cardiomyopathy, and infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, and nodular disease)
  • echocardiographic evidence of intracardiac mass or thrombus;
  • implant of cardiac device (pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy device, or left atria appendage closure);
  • hemodynamic instability requiring cardiac assist devices, intra-aortic balloon pump (IABP), or other hemodynamic support;
  • any percutaneous cardiac intervention (percutaneous coronary intervention, transcatheter aortic valve replacement, etc.) within the 30 days prior to randomization,
  • any cardiac surgery within the 6 months prior to randomization;
  • active infections requiring current antibiotic therapy;
  • a known hypersensitivity or contradiction to procedure medications which cannot be adequately managed medically;
  • contraindication to appropriate anti-coagulation therapy;
  • chronic obstructive pulmonary disease (COPD) requiring continuous home oxygen therapy or chronic oral steroid therapy;
  • acute cerebrovascular accident within 30 days prior to randomization or Modified Rankin Score ≥ 4;
  • symptomatic severe carotid stenosis (>70% by ultrasound);
  • other planned surgical or interventional procedures within the next 3 months;
  • liver failure;
  • renal failure or dialysis status;
  • pregnant or planning pregnancy within the next 3 months;
  • life expectancy < 12 months (e.g., advanced malignant tumors);
  • currently participating in other interventional studies;
  • circumstances that, in the judgment of the researcher, make participation in this study unsuitable.

Trial locations and contacts

17 sites in 1 country. Contact the study team or a site near you to ask about taking part.

liu HE, MD contact

+86 13810720787

theliu@139.com

Caihua Sang, MD contact

17 sites in 1 country

China17 sites, 17 recruiting

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100029

    Liu HE, MD, +86 13810720787, theliu@139.com

    Caihua Sang, MD, +86 010-81992281, sch9613070@sina.com

    Recruiting

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

    Yida Tang, MD, +86 13901010211, tang_yida@163.com

    Yida Tang, MD

    Recruiting

  • The first hospital of Jilin University

    Changchun, Jilin, 130000

    Yang Yu, MD, fredyy@163.com

    Yang Yu, MD

    Not yet recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510000

    Wei Wei, MD, +86 13724893386, weiwei@gdph.org.cn

    Wei Wei, MD

    Not yet recruiting

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

    Chenyang Jiang, MD, +86 13857190051, jiangchenyangmail@163.com

    Chenyang Jiang, MD

    Recruiting

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

    Yue Li, MD, +86 13945057313, ly99ly@vip.163.com

    Yue Li, MD

    Recruiting

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 450052

    Bo Yu, MD, +86 13804585601, yubodr@163.com

    Bo Yu, MD

    Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

    Ronghui Yu, MD, +86 13901080383, ronghuiyu@vip.sina.com

    Ronghui Yu, MD

    Recruiting

  • Shandong Provincial Qianfoshan Hospital

    Jinan, Shandong, 250000

    Hesheng Hu, MD, +86 13589112300, hyperhhs@163.com

    Hesheng Hu, MD

    Recruiting

  • The Second Hospital of Hebeimedical University

    Shijiazhuang, Hebei, 050000

    Jingzhao Lu, MD, +86 13230177989, ljchb2h@hebmu.edu.cn

    Jingzhao Lu, MD

    Recruiting

  • Wuhan Asia Heart Hospital

    Wuhan, Hubei, 430022

    Hua Yan, MD, +86 13100659066, yanhua0807@aliyun.com

    Hua Yan, MD

    Recruiting

  • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

    Yan Wang, MD, +86 13697326307, newswangyan@126.com

    Yan Wang, MD

    Recruiting

  • Tangdu Hospital-Air Force Medical University

    Xi’an, Shanxi, 710000

    Yan Li, MD, +86 13892890227, profleeyan@163.com

    Yan Li, MD

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710061

    Zuyi Yuan, MD, +86 13571828319, zuyiyuan@xjtu.edu.cn

    Zuyi Yuan, MD

    Not yet recruiting

  • Xiamen University Affiliated Cardiovascular Hospital

    Xiamen, Fujian, 361006

    Yan Wang, MD, +86 13860488088, wy@medmail.com.cn

    Yan Wang, MD

    Not yet recruiting

  • People's Hospital of Ningxia Hui Autonomous Region

    Yinchuan, Ningxia, 750002

    Shaojing Xi, MD, +86 18295107706, xishaojing0318@163.com

    Shaojing Xi, MD

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Yingwei Chen, MD, +86 18639001891, zzchenyingwei@126.com

    Yingwei Chen, MD

    Not yet recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Catheter abLation in patiEnts With seVere mitrAl regurgiTation and pErsistent Atrial Fibrillation: a Randomized Controlled Trial(ELEVATE-AF)

Atrial fibrillation (AF) leads to atrial functional mitral regurgitation (MR) through mechanisms including mitral annular dilatation, systolic leaflet motion distance alteration, and contractility decrease. Compared with primary MR, atrial functional MR due to AF and other diseases tends to have a worse prognosis, with a higher risk of death and heart failure hospitalization. MR and AF co-exist and exacerbate left atrial dysfunction, further causing worse cardiac dysfunction, valvular regurgitation, and aggravating prognosis.

The best therapy for secondary MR is unclear because MR is only one component of the disease, and restoration of mitral valve competence is not curative. Catheter ablation improves symptoms and cardiac function in patients with AF, reduces risks of AF recurrence and hospitalization, as well as increases quality of life. For patients with AF combined with functional moderate-to-severe MR, previous observational studies have found that the severity of MR significantly reduced after taking catheter ablation to restore sinus rhythm. We hypothesized that catheter ablation would significantly improve the severity of MR in patients with severe atrial functional MR combined with persistent AF compared with drug therapy alone.

Read the detailed description

The ELEVATE-AF is a multi-center, open-label, parallel design, randomized controlled trial. Eligible subjects will be randomized in a 1:1 ratio to the catheter ablation combined with drug group or to the drug-alone group. A total of 146 patients with persistent atrial fibrillation and severe atrial functional mitral regurgitation (MR) (severity of moderate-to-severe [3+] or severe [4+]) will be enrolled at up to 17 investigational sites in China. The enrollment period is estimated to last approximately 18 months. The primary endpoint is the proportion of patients with residual MR of moderate [2+] or less assessed by transthoracic echocardiography at 3 months. MR severity is confirmed by the Echocardiography Core Lab according to the American Society of Cardiac Ultrasound criteria (mitral effective regurgitant orifice area [EROA)]≤20 mm2). The secondary endpoints evaluate: (i)all-cause mortality; (ii)cardiovascular hospitalization; (iii)undergoing interventional or surgical treatment of mitral valve; (iv)heart failure hospitalization or emergency room visit; (v)change in scores on the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire, and the 5-level EQ-5D version (EQ-5D-5L); (vi) freedom from any documented atrial arrhythmias lasting more than 30 seconds and atrial fibrillation burden. The safety endpoints include: (i)perioperative surgical complications (within 30 days after catheter ablation procedure); (ii)major bleeding (ISTH definition); (iii)stroke and systemic embolism.

As an extension of the ELEVATE-AF trial, ELEVATE-AF X study will conducted after 3-month follow-up of ELEVATE-AF. The ELEVATE-AF X study is designed as a prospective, multi-center, continued access registry study. The objective of the this study is to validate the long-term outcomes of catheter ablation procedure in patients with persistent AF and severe atrial functional MR. All patients will receive catheter ablation if the procedure is needed, and the medical therapy for ELEVATE-AF X is identical to that of ELEVATE-AF trial. Active follow-up of patients will be performed through 12 months.

Being tested
Catheter ablation plus medication, Medication, (ELEVATE-AF X) experimental group, (ELEVATE-AF X) control group
Keywords
atrial fibrillation, mitral regurgitation, catheter ablation
Medical subject headings
Atrial Fibrillation, Mitral Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Catheter ablation plus medicationProcedure or surgery

    All patients will receive atrial fibrillation catheter ablation. They also should receive guideline-directed medical therapy, anticoagulation, and rate control with medications according to the guidelines.

  • MedicationDrug

    Patients will receive guideline-directed medical therapy, anticoagulation, and rate control according to the guidelines for the management of AF and heart failure.

  • (ELEVATE-AF X) experimental groupProcedure or surgery

    Subsequent ablations may be considered for patients with recurrence，and the medical therapy for ELEVATE-AF X is identical to that of the ELEVATE-AF trial.

  • (ELEVATE-AF X) control groupProcedure or surgery

    All patients could receive catheter ablation if the procedure is needed, and the medical therapy for ELEVATE-AF X is identical to that of the ELEVATE-AF trial.

Study groups in NCT06883864
Study groupRoleWhat they receive
Catheter ablation plus medication groupExperimentalAll patients assigned to the catheter ablation group will receive AF catheter ablation and receive the same medical therapy as the control group.
Receives: Procedure: Catheter ablation plus medication; Procedure: (ELEVATE-AF X) experimental group
Medication groupActive comparatorAll patients should receive guideline-directed medical therapy, anticoagulation, and rate control with medications according to the guidelines.
Receives: Drug: Medication; Procedure: (ELEVATE-AF X) control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary endpoint is the proportion of patients with residual MR of moderate [2+] or less assessed by transthoracic echocardiography at 3 months.

    The primary endpoint is the proportion of patients with residual MR of moderate [2+] or less assessed by transthoracic echocardiography at 3 months. MR severity is confirmed by the Echocardiography Core Lab according to the American Society of Cardiac Ultrasound criteria (mitral effective regurgitant orifice area [EROA)]≤20 mm2).

    Measured: 3 month

Secondary outcomes (17)

  1. all-cause mortality

    Measured: 3 month

  2. cardiovascular hospitalization

    Measured: 3 month

  3. undergoing interventional or surgical treatment of mitral valve

    Measured: 3 month

  4. heart failure hospitalization or emergency room visit

    Measured: 3 month

  5. Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) score change between baseline and 3 month

    Quality of life assessed by AFEQT questionaire

    Measured: 3 month

  6. EuroQoL 5-Dimension 5-Level (EQ-5D-5L) score change between baseline and 3 month

    Quality of life assessed by EQ-5D-5L scale

    Measured: 3 month

  7. freedom from any documented atrial arrhythmias lasting more than 30 seconds and atrial fibrillation burden

    Measured: 3 month

  8. Change from baseline to 3 months in the 6-minute walk distance

    Measured: 3 months

  9. (ELEVATE-AF X) the proportion of patients with residual MR of moderate [2+] or less assessed by transthoracic echocardiography

    Measured: 12 month

  10. (ELEVATE-AF X) all-cause mortality

    Measured: 12 month

  11. (ELEVATE-AF X) cardiovascular hospitalization

    Measured: 12 month

  12. (ELEVATE-AF X) undergoing interventional or surgical treatment of mitral valve

    Measured: 12 month

  13. (ELEVATE-AF X) heart failure hospitalization or emergency room visit

    Measured: 12 month

  14. (ELEVATE-AF X) Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) score change between baseline and 12 month

    Quality of life assessed by AFEQT questionaire

    Measured: 12 month

  15. (ELEVATE-AF X) EuroQoL 5-Dimension 5-Level (EQ-5D-5L) score change between baseline and 12 month

    Quality of life assessed by EQ-5D-5L scale

    Measured: 12 month

  16. (ELEVATE-AF X) freedom from any documented atrial arrhythmias lasting more than 30 seconds and atrial fibrillation burden

    Measured: 12 month

  17. (ELEVATE-X) Change from baseline to 12 months in the 6-minute walk distance

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2025
  2. Study start8 Apr 2025
  3. Primary completion1 Aug 2027 (estimated)
  4. Study completion1 May 2028 (estimated)

Resources

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
None (open label)
Enrolment
146 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06883864
Sponsor's protocol ID
2025KLS10
Other IDs
2022YFC3601303
Acronym
ELEVATE-AF
Status last verified
Mar 2026
First submitted
11 Mar 2025
Last updated
13 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Catheter ablation plus medication, Medication and (ELEVATE-AF X) experimental group in people with Atrial Fibrillation (AF) and Catheter Ablation, run by Beijing Anzhen Hospital at 17 sites 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 6 inclusion and 26 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 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites 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. 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, MD (+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?

The primary endpoint is the proportion of patients with residual MR of moderate [2+] or less assessed by transthoracic echocardiography at 3 months. (time frame: 3 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06883864.

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 13 Mar 2026.

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