Atrial FibrillationNCT05610215
Concomitant Hybrid Versus Catheter Ablation for Atrial Fibrillation With Hypertrophic Cardiomyopathy
A study testing hybrid ablation and catheter ablation in people with Atrial Fibrillation and Cardiomyopathy, Hypertrophic, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
The goal of this clinical trial is to compare the rhythm control effect in hypertrophic non-obstructive patients with non-paroxysmal atrial fibrillation by either concomitant catheter endocardial and thoracoscopic epicardial ablation or catheter ablation alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Cardiomyopathy, Hypertrophic, Radiofrequency Ablation
- What is being tested?
- hybrid ablation and catheter ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 11 Feb 2023to Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients' age is ≥18 y
- Clinically diagnosed hypertrophic cardiomyopathy (any left ventricular wall segment thickness ≥15 mm in genetical negative (or unknown genetical status) patients or ≥13mm in genetical positive ones-as measured by any imaging technique (echocardiography, cardiac magnetic resonance imaging or computed tomography)-that is not explained solely by loading conditions)
- Non-obstructed left ventricular outflow obstruction with peak gradients <30mmHg
- Concomitant with persistent atrial fibrillation (7 days<sustained episode lasting<3 years) with drug-refractory symptoms.
- Be able to understand the contents of the trial, and provide written informed consent to participate in this investigation.
Who cannot join
- Patients with left atrial size >60 mm (2-dimensional echocardiography, parasternal long-axis view)
- Contraindicated to systemic anticoagulation
- Left ventricular ejection fraction ≤40%
- Concomitant with left atrium or left atrial appendage emboli
- Concomitant with a coronary or valvular disease that indicates intervention
- Ischaemic stroke within 2 months
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- Previous ablation history
- Uncontrolled hyper/hypothyroidism
- End-staged kidney failure
- Concomitantly involved in other trials
- Pregnant or breastfeeding, or women of childbearing age not using a reliable contraceptive method
- Concomitant with bacteremia or at an active phase of infection
- Anatomically not suitable for thoracoscopic surgery(history of chest surgery or radiotherapy, etc.)
- Unwilling or unable to comply with all peri-ablation and follow-up requirements
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
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing
Zhe Zheng, MD,PhD, +86-010-88396051, zhengzhe@fuwai.com
Yajie Tang, MD,PhD, +8618813019554, tangyajietangyajie@126.com
About this study
Official title: Concomitant Hybrid Versus Catheter Ablation for Reinforcing Therapeutic Effect of Atrial Fibrillation With Hypertrophic Cardiomyopathy
The goal of this clinical trial is to compare the rhythm control effect in hypertrophic non-obstructive patients with non-paroxysmal atrial fibrillation by either concomitant catheter endocardial and thoracoscopic epicardial ablation or catheter ablation alone. The study aims to see if concomitant hybrid ablation can more effectively achieve rhythm control effect than catheter ablation alone in non-paroxysmal atrial fibrillation patients with hypertrophic cardiomyopathy.
Read the detailed description
After informed consent, 66 eligible admissions will be recruited in 2 centers. Eligible participants will be randomly divided (1:1) into either hybrid or catheter ablation arms, looking for a primary outcome of 1-year freedom from atrial arrhythmias.
- Being tested
- hybrid ablation, catheter ablation
- Medical subject headings
- Atrial Fibrillation, Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hybrid ablationProcedure or surgery
simultaneous thoracoscopic epicardial and catheter endocardial ablation
catheter ablationProcedure or surgery
catheter endocardial ablation
| Study group | Role | What they receive |
|---|---|---|
| hybrid ablation | Experimental | Participants in this group will receive concomitant thoracoscopic epicardial ablation and catheter endocardial ablation Receives: Procedure: hybrid ablation |
| catheter ablation | Active comparator | Participants in this group will receive catheter endocardial ablation only Receives: Procedure: catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from documented recurrence (off-AADs)
freedom from documented AF/AT episodes >30 seconds (off-AADs) by 72-hour holter monitoring
Measured: within 3-12 months
Secondary outcomes (7)
All cause mortality
death by any reason
Measured: within 12 months
Cardiovascular related mortality
death that related to cardiogenic causes
Measured: within 12 months
Cerebral infarction/ischemia
Any stroke or TIA diagnosed in the clinical record after the completion of the intervention
Measured: within 12 months
Periferal arterial embolism
Periferal arterial embolism
Measured: within 12 months
All-cause rehospitalization
Rehospitalized by any reason
Measured: within 3-12 months
Heart failure related rehospitalization
Rehospitalized by the cause of heart failure episode
Measured: within 3-12 months
Freedom from documented recurrence (on-AADs)
freedom from documented AF/AT episodes >30 seconds (on-AADs) by 72-hour holter monitoring
Measured: within 3-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start11 Feb 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (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 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 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
- NCT05610215
- Sponsor's protocol ID
- 2022-1736
- Status last verified
- Aug 2024
- First submitted
- 2 Nov 2022
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tang Y, Li L, Chen S, Xue Y, Guo H, Song L, Tang M, Yao Y, Zheng Z. Hybrid versus catheter ablation for Hypertrophic CardioMyopathy with Atrial Fibrillation (HCM-AF): study protocol for a randomised controlled trial. BMJ Open. 2024 Oct 9;14(10):e089284. doi: 10.1136/bmjopen-2024-089284.
PubMed 39384237
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concomitant Hybrid Versus Catheter Ablation for Reinforcing Therapeutic Effect of Atrial Fibrillation With Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT05610215
- Acronym / sponsor ID
- 2022-1736
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 11 Feb 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Nov 2022 (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 goal of this clinical trial is to compare the rhythm control effect in hypertrophic non-obstructive patients with non-paroxysmal atrial fibrillation by either concomitant catheter endocardial and thoracoscopic epicardial ablation or catheter ablation alone. The study aims to see if concomitant hybrid ablation can more effectively achieve rhythm control effect than catheter ablation alone in non-paroxysmal atrial fibrillation patients with hypertrophic cardiomyopathy.
Detailed description
After informed consent, 66 eligible admissions will be recruited in 2 centers. Eligible participants will be randomly divided (1:1) into either hybrid or catheter ablation arms, looking for a primary outcome of 1-year freedom from atrial arrhythmias.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hybrid ablation | Experimental | Procedure: hybrid ablationParticipants in this group will receive concomitant thoracoscopic epicardial ablation and catheter endocardial ablation |
| catheter ablation | Active comparator | Procedure: catheter ablationParticipants in this group will receive catheter endocardial ablation only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients' age is ≥18 y
- Clinically diagnosed hypertrophic cardiomyopathy (any left ventricular wall segment thickness ≥15 mm in genetical negative (or unknown genetical status) patients or ≥13mm in genetical positive ones-as measured by any imaging technique (echocardiography, cardiac magnetic resonance imaging or computed tomography)-that is not explained solely by loading conditions)
- Non-obstructed left ventricular outflow obstruction with peak gradients <30mmHg
- Concomitant with persistent atrial fibrillation (7 days<sustained episode lasting<3 years) with drug-refractory symptoms.
- Be able to understand the contents of the trial, and provide written informed consent to participate in this investigation.
Key exclusion criteria (14 listed)
- Patients with left atrial size >60 mm (2-dimensional echocardiography, parasternal long-axis view)
- Contraindicated to systemic anticoagulation
- Left ventricular ejection fraction ≤40%
- Concomitant with left atrium or left atrial appendage emboli
- Concomitant with a coronary or valvular disease that indicates intervention
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 |
|---|---|---|
| hybrid ablationsimultaneous thoracoscopic epicardial and catheter endocardial ablation | Procedure or surgery | hybrid ablation |
| catheter ablationcatheter endocardial ablation | Procedure or surgery | catheter ablation |
Primary outcome
Freedom from documented recurrence (off-AADs)
Time frame: within 3-12 months
freedom from documented AF/AT episodes >30 seconds (off-AADs) by 72-hour holter monitoring
7 secondary outcomes
All cause mortality
Time frame: within 12 months
Cardiovascular related mortality
Time frame: within 12 months
Cerebral infarction/ischemia
Time frame: within 12 months
Periferal arterial embolism
Time frame: within 12 months
All-cause rehospitalization
Time frame: within 3-12 months
Heart failure related rehospitalization
Time frame: within 3-12 months
Freedom from documented recurrence (on-AADs)
Time frame: within 3-12 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 30 Aug 2024.
- Derived from this study: PubMed 39384237Tang Y, Li L, Chen S, Xue Y, Guo H, Song L, Tang M, Yao Y, Zheng Z. Hybrid versus catheter ablation for Hypertrophic CardioMyopathy with Atrial Fibrillation (HCM-AF): study protocol for a randomised controlled trial. BMJ Open. 2024 Oct 9;14(10):e089284. doi: 10.1136/bmjopen-2024-089284.
Related trials for Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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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.
Zhe Zheng, MD.PhD study chair
Chinese Academy of Medical Sciences, Fuwai 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 hybrid ablation and catheter ablation in people with Atrial Fibrillation and Cardiomyopathy, Hypertrophic, run by China National Center for Cardiovascular Diseases 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 5 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 30 Aug 2024. 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. 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 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?
Freedom from documented recurrence (off-AADs) (time frame: within 3-12 months). 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 NCT05610215, 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 30 Aug 2024.