Hybrid versus catheter ablation for Hypertrophic CardioMyopathy with Atrial Fibrillation (HCM-AF): study protocol for a randomised controlled trial
Introduction Atrial fibrillation (AF) is an independent predictor of adverse outcomes in patients with hypertrophic cardiomyopathy (HCM). Although catheter ablation is highly recommended for general AF populations, it is less effective in maintaining sinus rhythm in patients with HCM associated with...
Saved in:
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2024-10-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/10/e089284.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849720547364044800 |
|---|---|
| author | Yan Yao Zhe Zheng Lei Song Min Tang Le Li Sipeng Chen Huiming Guo Yajie Tang Yumei Xue |
| author_facet | Yan Yao Zhe Zheng Lei Song Min Tang Le Li Sipeng Chen Huiming Guo Yajie Tang Yumei Xue |
| author_sort | Yan Yao |
| collection | DOAJ |
| description | Introduction Atrial fibrillation (AF) is an independent predictor of adverse outcomes in patients with hypertrophic cardiomyopathy (HCM). Although catheter ablation is highly recommended for general AF populations, it is less effective in maintaining sinus rhythm in patients with HCM associated with AF. Hybrid ablation, combining a cosmetic approach with a lower rate of AF relapse, lacks comparative studies to verify its efficacy against CA in HCM. This study aims to assess the rhythm control effectiveness of hybrid versus CA in non-obstructive HCM (non-oHCM) patients with AF.Methods/analysis This prospective, multicentre, randomised trial involves a blinded assessment of outcomes in non-oHCM patients with non-paroxysmal AF. Sixty-six candidates from three centres will be randomised 1:1 to either hybrid or CA, including isthmus addressed lesion sets. Participants will be stratified by left atrial (LA) size (LA diameter ≤50 mm or >50 mm). Follow-ups at the 3rd, 6th and 12th months will evaluate the primary endpoint of freedom from documented atrial tachycardia lasting over 30 s within 12 months post-procedure without antiarrhythmic drugs, along with secondary endpoints of all-cause mortality, cardiovascular-related mortality, cerebral stroke, peripheral vascular embolism, heart failure-related rehospitalisation, all-cause rehospitalisation and quality of life assessments.Ethics and disseminationapproval The central ethics committee at Fuwai Hospital has approved the Hypertrophic CardioMyopathy with Atrial Fibrillation trial (approval number: 2022-1736). Results will be disseminated through publications in peer-reviewed journals and presentations at conferences.Trial registration number NCT05610215. |
| format | Article |
| id | doaj-art-9a3b8dfa821d423c85da411a6c02c0e4 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-10-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-9a3b8dfa821d423c85da411a6c02c0e42025-08-20T03:11:54ZengBMJ Publishing GroupBMJ Open2044-60552024-10-01141010.1136/bmjopen-2024-089284Hybrid versus catheter ablation for Hypertrophic CardioMyopathy with Atrial Fibrillation (HCM-AF): study protocol for a randomised controlled trialYan Yao0Zhe Zheng1Lei Song2Min Tang3Le Li4Sipeng Chen5Huiming Guo6Yajie Tang7Yumei Xue8Fuwai Shenzhen Hospital,Chinese Academy of Medical Sciences, Shenzhen, People`s Republic of ChinaState Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People`s Republic of ChinaState Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People`s Republic of ChinaFuwai Hospital State Key Laboratory of Cardiovascular Disease, Beijing, ChinaState Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People`s Republic of ChinaNational Clinical Research Center of Cardiovascular Diseases，Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People`s Republic of ChinaDepartment of Cardiovascular Surgery, Guangdong Provincial People`s Hospital, Guangzhou, Guangdong, People`s Republic of ChinaState Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People`s Republic of ChinaDepartment of Arrhythmia, Guangdong Provincial People`s Hospital, Guangzhou, Guangdong, People`s Republic of ChinaIntroduction Atrial fibrillation (AF) is an independent predictor of adverse outcomes in patients with hypertrophic cardiomyopathy (HCM). Although catheter ablation is highly recommended for general AF populations, it is less effective in maintaining sinus rhythm in patients with HCM associated with AF. Hybrid ablation, combining a cosmetic approach with a lower rate of AF relapse, lacks comparative studies to verify its efficacy against CA in HCM. This study aims to assess the rhythm control effectiveness of hybrid versus CA in non-obstructive HCM (non-oHCM) patients with AF.Methods/analysis This prospective, multicentre, randomised trial involves a blinded assessment of outcomes in non-oHCM patients with non-paroxysmal AF. Sixty-six candidates from three centres will be randomised 1:1 to either hybrid or CA, including isthmus addressed lesion sets. Participants will be stratified by left atrial (LA) size (LA diameter ≤50 mm or >50 mm). Follow-ups at the 3rd, 6th and 12th months will evaluate the primary endpoint of freedom from documented atrial tachycardia lasting over 30 s within 12 months post-procedure without antiarrhythmic drugs, along with secondary endpoints of all-cause mortality, cardiovascular-related mortality, cerebral stroke, peripheral vascular embolism, heart failure-related rehospitalisation, all-cause rehospitalisation and quality of life assessments.Ethics and disseminationapproval The central ethics committee at Fuwai Hospital has approved the Hypertrophic CardioMyopathy with Atrial Fibrillation trial (approval number: 2022-1736). Results will be disseminated through publications in peer-reviewed journals and presentations at conferences.Trial registration number NCT05610215.https://bmjopen.bmj.com/content/14/10/e089284.full |
| spellingShingle | Yan Yao Zhe Zheng Lei Song Min Tang Le Li Sipeng Chen Huiming Guo Yajie Tang Yumei Xue Hybrid versus catheter ablation for Hypertrophic CardioMyopathy with Atrial Fibrillation (HCM-AF): study protocol for a randomised controlled trial BMJ Open |
| title | Hybrid versus catheter ablation for Hypertrophic CardioMyopathy with Atrial Fibrillation (HCM-AF): study protocol for a randomised controlled trial |
| title_full | Hybrid versus catheter ablation for Hypertrophic CardioMyopathy with Atrial Fibrillation (HCM-AF): study protocol for a randomised controlled trial |
| title_fullStr | Hybrid versus catheter ablation for Hypertrophic CardioMyopathy with Atrial Fibrillation (HCM-AF): study protocol for a randomised controlled trial |
| title_full_unstemmed | Hybrid versus catheter ablation for Hypertrophic CardioMyopathy with Atrial Fibrillation (HCM-AF): study protocol for a randomised controlled trial |
| title_short | Hybrid versus catheter ablation for Hypertrophic CardioMyopathy with Atrial Fibrillation (HCM-AF): study protocol for a randomised controlled trial |
| title_sort | hybrid versus catheter ablation for hypertrophic cardiomyopathy with atrial fibrillation hcm af study protocol for a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/14/10/e089284.full |
| work_keys_str_mv | AT yanyao hybridversuscatheterablationforhypertrophiccardiomyopathywithatrialfibrillationhcmafstudyprotocolforarandomisedcontrolledtrial AT zhezheng hybridversuscatheterablationforhypertrophiccardiomyopathywithatrialfibrillationhcmafstudyprotocolforarandomisedcontrolledtrial AT leisong hybridversuscatheterablationforhypertrophiccardiomyopathywithatrialfibrillationhcmafstudyprotocolforarandomisedcontrolledtrial AT mintang hybridversuscatheterablationforhypertrophiccardiomyopathywithatrialfibrillationhcmafstudyprotocolforarandomisedcontrolledtrial AT leli hybridversuscatheterablationforhypertrophiccardiomyopathywithatrialfibrillationhcmafstudyprotocolforarandomisedcontrolledtrial AT sipengchen hybridversuscatheterablationforhypertrophiccardiomyopathywithatrialfibrillationhcmafstudyprotocolforarandomisedcontrolledtrial AT huimingguo hybridversuscatheterablationforhypertrophiccardiomyopathywithatrialfibrillationhcmafstudyprotocolforarandomisedcontrolledtrial AT yajietang hybridversuscatheterablationforhypertrophiccardiomyopathywithatrialfibrillationhcmafstudyprotocolforarandomisedcontrolledtrial AT yumeixue hybridversuscatheterablationforhypertrophiccardiomyopathywithatrialfibrillationhcmafstudyprotocolforarandomisedcontrolledtrial |