Persistent Atrial FibrillationNCT05021601
Bi-atrial Versus Left Atrial Ablation for Patients With Rheumatic Mitral Valve Disease and Non-paroxysmal Atrial Fibrillation
A study testing Bi-atrial ablation and Left atrial ablation in people with Persistent Atrial Fibrillation, run by China National Center for Cardiovascular Diseases at 2 sites in China.
Trial summary
This study is aimed to compare the efficacy of bi-atrial ablation with left atrial ablation for atrial fibrillation during mitral valve surgery in patients with rheumatic mitral valve disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Bi-atrial ablation and Left atrial ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 2 sitesChina
- Study dates
- 10 May 2022to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Diagnosis of persistent atrial fibrillation(AF) or long-standing persistent AF by medical history and Holter monitoring (persistent AF lasting more than 7 days; long-standing persistent AF lasting more than 1 year).
- Rheumatic mitral valve disease(RMVD) requires mitral valve surgery( RMVD was determined by history of acute rheumatic fever, valve morphology, echocardiographic findings and pathological diagnosis).
- Consent to surgical ablation of AF
Who cannot join
- Paroxysmal AF
- Degenerative or ischemic mitral valve disease
- Evidence of active infection
- Previous catheter ablation or surgical ablation for AF
- Surgical management of hypertrophic obstructive cardiomyopathy
- Absolute contraindications for anticoagulation therapy
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- Left atrial thrombosis (not including left atrial appendage thrombosis alone)
- Chronic obstructive pulmonary disease(Forced expiratory volume in 1 second (FEV1)<30% anticipated value)
- Uncontrolled hypo- or hyperthyroidism
- Mental impairment or other conditions that may not allow participants to understand the nature, significance, and scope of study
- Left atrial diameter>70mm
- Right ventricular dysfunction (TAPSE<16) or moderate to severe tricuspid regurgitation or pulmonary artery pressure (estimated by echocardiography) >60mmHg
- Coronary artery bypass grafting is required for participants with coronary heart disease
- Previous cardiac surgery
- Refuse to participate in this study
Trial locations and contacts
2 sites in 1 country.
Chunyu Yu, MD contact
China2 sites, 2 recruiting
- Recruiting
Fuwai Hospital
Beijing, Beijing Municipality
Chunyu Yu, MD, yuchunyu@fuwai.com
- Recruiting
Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu
Xin Chen
About this study
Official title: Bi-atrial Versus Left Atrial Ablation for Patients With Rheumatic Mitral Valve Disease and Non-paroxysmal Atrial Fibrillation: a Multicenter, Prospective, Randomized Controlled Trial
This study is aimed to compare the efficacy of bi-atrial ablation with left atrial ablation for atrial fibrillation during mitral valve surgery in patients with rheumatic mitral valve disease.
Read the detailed description
Atrial fibrillation (AF) is present in 40%-60% of patients with rheumatic mitral valve disease (RMVD), which is an independent predictor of mortality and late stroke. During mitral valve (MV) surgery, the open left atrium facilitates a bi-atrial ablation procedure. However, a simplified lesion set including isolated pulmonary vein isolation or posterior left atrial (LA) wall isolation or LA maze was usually applied. The current literatures provide insufficient evidence to determine the potential benefits of bi-atrial ablation procedure when comparing with LA ablation procrdure in patients with non-paroxysmal AF and RMVD.
Patients with RMVD often have longer history, which tends to affect the right atrium, including pulmonary hypertension or tricuspid regurgitation.The necessity of bi-atrial ablation procedure targeting the bi-atrial substrate for AF in RMVD requires to be explored. In this study, we aimed to compare the efficacy of bi-atrial ablation with LA ablation for AF during MV surgery in patients with RMVD.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Bi-atrial ablation, Left atrial ablation
- Keywords
- Rheumatic mitral valve disease, Surgical ablation, Mitral valve surgery
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bi-atrial ablationProcedure or surgery
This intervention includes mitral valve surgery concomitant with left atrial ablation and right atrial ablation.
Left atrial ablationProcedure or surgery
This intervention includes mitral valve surgery concomitant with left atrial ablation alone.
| Study group | Role | What they receive |
|---|---|---|
| Bi-atrial ablation group | Experimental | Participants in this group will receive mitral valve surgery concomitant with bi-atrial ablation procedure. Receives: Procedure: Bi-atrial ablation |
| Left atrial ablation group | Active comparator | Participants in this group will receive mitral valve surgery concomitant with left atrial ablation procedure. Receives: Procedure: Left atrial ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate without any recurrence of atrial tachyarrhythmias in the absence of antiarrhythmic drugs
Without detections of atrial fibrillation, atrial flutter, or other atrial tachyarrhythmias with a duration of greater than 30 seconds documented by 3-day Holter monitoring in the absence of antiarrhythmic drugs.
Measured: At 12-month after intervention
Secondary outcomes (5)
Survival rate without permanent pacemaker implantation (Key secondary outcome)
Percentage of participants who did not have a new permanent pacemaker implanted.
Measured: At 12-month after intervention
Survival rate without any recurrence of atrial tachyarrhythmias with antiarrhythmic drugs
Without detections of atrial fibrillation, atrial flutter, or other atrial tachyarrhythmias with a duration of greater than 30 seconds documented by 3-day Holter monitoring with antiarrhythmic drugs.
Measured: At 12-month after intervention
Burden of atrial fibrillation
Burden of atrial fibrillation according to 3-day Holter monitoring.
Measured: At 12-month after intervention
Major adverse events
Including cardiac death, stroke, heart failure requiring rehospitalization, embolic events or bleeding events requiring rehospitalization.
Measured: At 12-month after intervention
Cardiac function
Documented by echocardiography (left ventricular ejection fraction).
Measured: At 12-month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start10 May 2022
- Primary completionJun 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Zhe Zheng, MD,PhD, Study chair, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021601
- Sponsor's protocol ID
- 2021-1515
- Status last verified
- Jun 2024
- First submitted
- 16 Aug 2021
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yu C, Li H, Wang Y, Chen S, Zhao Y, Zheng Z. Bi-atrial versus left atrial ablation for patients with rheumatic mitral valve disease and non-paroxysmal atrial fibrillation (ABLATION): rationale, design and study protocol for a multicentre randomised controlled trial. BMJ Open. 2022 Nov 29;12(11):e064861. doi: 10.1136/bmjopen-2022-064861.
PubMed 36446460
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bi-atrial Versus Left Atrial Ablation for Patients With Rheumatic Mitral Valve Disease and Non-paroxysmal Atrial Fibrillation: a Multicenter, Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05021601
- Acronym / sponsor ID
- 2021-1515
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- Rheumatic mitral valve disease, Surgical ablation, Mitral valve surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 10 May 2022 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 25 Aug 2021 (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.
This study is aimed to compare the efficacy of bi-atrial ablation with left atrial ablation for atrial fibrillation during mitral valve surgery in patients with rheumatic mitral valve disease.
Detailed description
Atrial fibrillation (AF) is present in 40%-60% of patients with rheumatic mitral valve disease (RMVD), which is an independent predictor of mortality and late stroke. During mitral valve (MV) surgery, the open left atrium facilitates a bi-atrial ablation procedure. However, a simplified lesion set including isolated pulmonary vein isolation or posterior left atrial (LA) wall isolation or LA maze was usually applied. The current literatures provide insufficient evidence to determine the potential benefits of bi-atrial ablation procedure when comparing with LA ablation procrdure in patients with non-paroxysmal AF and RMVD.
Patients with RMVD often have longer history, which tends to affect the right atrium, including pulmonary hypertension or tricuspid regurgitation.The necessity of bi-atrial ablation procedure targeting the bi-atrial substrate for AF in RMVD requires to be explored. In this study, we aimed to compare the efficacy of bi-atrial ablation with LA ablation for AF during MV surgery in patients with RMVD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bi-atrial ablation group | Experimental | Procedure: Bi-atrial ablationParticipants in this group will receive mitral valve surgery concomitant with bi-atrial ablation procedure. |
| Left atrial ablation group | Active comparator | Procedure: Left atrial ablationParticipants in this group will receive mitral valve surgery concomitant with left atrial ablation procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Diagnosis of persistent atrial fibrillation(AF) or long-standing persistent AF by medical history and Holter monitoring (persistent AF lasting more than 7 days; long-standing persistent AF lasting more than 1 year).
- Rheumatic mitral valve disease(RMVD) requires mitral valve surgery( RMVD was determined by history of acute rheumatic fever, valve morphology, echocardiographic findings and pathological diagnosis).
- Consent to surgical ablation of AF
Key exclusion criteria (15 listed)
- Paroxysmal AF
- Degenerative or ischemic mitral valve disease
- Evidence of active infection
- Previous catheter ablation or surgical ablation for AF
- Surgical management of hypertrophic obstructive cardiomyopathy
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 |
|---|---|---|
| Bi-atrial ablationThis intervention includes mitral valve surgery concomitant with left atrial ablation and right atrial ablation. | Procedure or surgery | Bi-atrial ablation group |
| Left atrial ablationThis intervention includes mitral valve surgery concomitant with left atrial ablation alone. | Procedure or surgery | Left atrial ablation group |
Primary outcome
Survival rate without any recurrence of atrial tachyarrhythmias in the absence of antiarrhythmic drugs
Time frame: At 12-month after intervention
Without detections of atrial fibrillation, atrial flutter, or other atrial tachyarrhythmias with a duration of greater than 30 seconds documented by 3-day Holter monitoring in the absence of antiarrhythmic drugs.
5 secondary outcomes
Survival rate without permanent pacemaker implantation (Key secondary outcome)
Time frame: At 12-month after intervention
Survival rate without any recurrence of atrial tachyarrhythmias with antiarrhythmic drugs
Time frame: At 12-month after intervention
Burden of atrial fibrillation
Time frame: At 12-month after intervention
Major adverse events
Time frame: At 12-month after intervention
Cardiac function
Time frame: At 12-month after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Derived from this study: PubMed 36446460Yu C, Li H, Wang Y, Chen S, Zhao Y, Zheng Z. Bi-atrial versus left atrial ablation for patients with rheumatic mitral valve disease and non-paroxysmal atrial fibrillation (ABLATION): rationale, design and study protocol for a multicentre randomised controlled trial. BMJ Open. 2022 Nov 29;12(11):e064861. doi: 10.1136/bmjopen-2022-064861.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Chunyu Yu, MD contact
Zhe Zheng, MD,PhD study chair
Chinese Academy of Medical Sciences, Fuwai Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bi-atrial ablation and Left atrial ablation in people with Persistent Atrial Fibrillation, run by China National Center for Cardiovascular Diseases at 2 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 4 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhe Zheng, MD,PhD (: +86-010-88396051, zhengzhe@fuwai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate without any recurrence of atrial tachyarrhythmias in the absence of antiarrhythmic drugs (time frame: At 12-month after intervention). 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 NCT05021601, which also lists 1 linked publication.
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 Jun 2024.