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American Heart Journal

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The randomized controlled trial to compare temporary permanent pacemaker vs temporary pacemaker in patients with conduction block after transcatheter aortic valve replacement: Rationale and design of the RECOVER trial - 23/05/25

Doi : 10.1016/j.ahj.2025.04.017 
Zhengming Jiang, MD a, #, Sanshuai Chang, MD a, #, Ling Tao, MD b, Jianfang Luo, MD c, Guosheng Fu, MD d, Yan Wang, MD e, Wenzhi Pan, MD f, Lianglong Chen, MD g, Zhenfei Fang, MD h, Yan Li, MD i, Ming Bai, MD j, Bo Yu, MD k, i, Xiang Cheng, MD l, Xiaoping Peng, MD m, Hasan Jilaihawi, MD n, Nicolo Piazza, MD o, Thomas Modine, MD p, Guangyuan Song, MD a, ⁎

The RECOVER Investigators

a Interventional Center of Valvular Heart Disease, Beijing AnZhen Hospital, Capital Medical University, National Clinical Research Centre for Cardiovascular Diseases, Beijing, China 
b Department of Cardiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China 
c Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangdong Cardiovascular Institute, Guangzhou, China 
d Department of Cardiology, Sir Run Run Shaw Hospital, Zhejiang University of Medicine, Hangzhou, China 
e Xiamen Heart Center, Xiamen University, Xiamen, China 
f Department of Cardiology, Shanghai Institute of Cardiovascular Disease, Zhongshan Hospital, Fudan University, Shanghai, China 
g Department of Cardiology, Fujian Medical University Union Hospital, Fuzhou, China 
h Departments of Cardiology, The Second Xiangya Hospital of Central South University, Hunan, China 
i Department of Cardiology, Tangdu Hospital, Fourth Military Medical University, Xi'an, China 
j Department of Cardiology, The First Hospital of Lanzhou University, Lanzhou, China 
k Department of Cardiology, The Second Affiliated Hospital of Harbin Medical University, Harbin, China 
l Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China 
m Department of Cardiology, The First Affiliated Hospital of Nanchang University, Nanchang, China 
n Heart Valve Center, NYU Langone Health, New York, USA 
o Division of Cardiology, Department of Medicine, McGill University Health Centre, Quebec, Canada 
p Hôpital Cardiologique de Haut-Leveque, Bordeaux University Hospital, Bordeaux, France 

⁎Reprint requests: Guangyuan Song, MD, Department of Cardiology, Beijing AnZhen Hospital, Capital Medical University, National Clinical Research Centre for Cardiovascular Diseases, Anzhen Road 2# Chaoyang District, Beijing 100029, China.Department of CardiologyBeijing AnZhen HospitalCapital Medical UniversityNational Clinical Research Centre for Cardiovascular DiseasesAnzhen Road 2# Chaoyang DistrictBeijing100029China

ABSTRACT

Rationale

Current guidelines and expert consensus recommend different time thresholds of temporary pacemaker (TM) indwelling in patients with conduction block after transcatheter aortic valve replacement (TAVR). Accordingly, this lack of clinical evidence and effective strategies has resulted in extensive variations in permanent pacemaker (PPM) implantation patterns, potentially leading to over-early PPM implantation. The use of a temporary permanent pacemaker (TPPM), which involves an active fixation pacing lead and an external pulse generator secured to the skin surface, may be effective and safe in these patients. TPPM may improve postoperative mobility and facilitate early discharge, while providing prolonged and stable pacing for the recovery of conduction block, thereby reducing unnecessary PPM implantation.

Design

The RECOVER trial is a prospective, multicenter, open-label, randomized controlled study comparing TPPM vs TM in patients with conduction block after TAVR. The trial will enroll 160 subjects across 13 sites in China. Inclusion criteria include patients with persistent third-degree atrioventricular block (AVB), second-degree AVB, first-degree AVB with symptoms (PR interval >300 ms), alternating bundle branch block or bifascicular block with syncope/blackness related symptoms occurred during TAVR procedure or within 1 month after TAVR. Enrolled patients will be randomized 1:1 to the TPPM group for a 1-month bridge or the TM group for conventional 24 to 48 hours pacing. The primary effectiveness endpoint is the rate of PPM implantation at 6 months after the occurrence of AVB. Secondary effectiveness endpoint is the rate of PPM implantation at 1 month after the occurrence of AVB. Safety endpoints include all-cause mortality and TPPM/TM/PPM procedure-related complications during the 6-month follow-up. Key data collected will include sociodemographic information, medical history, electrocardiograph, HOLTER, echocardiography, contrast-enhanced cardiac CT, details of procedures and pacemaker interrogation. Indication for PPM implantation will be adjudicated by an independent pacing electrophysiologist committee.

Conclusion

The RECOVER trial will evaluate whether TPPM is superior to conventional TM in reducing the rate of PPM implantation in patients with conduction block after TAVR, with a buffer period to distinguish whether conduction block is reversible or persistent.

Current status

The trial is still enrolling participants (with 14 enrolled as of January 1, 2025).

Trial registration

Randomized controlled trial to compare temporary permanent pacemaker vs temporary pacemaker in patients with conduction block after transcatheter aortic valve replacement. Chinese Clinical Trial Registry ChiCTR2400087536. Registered at July 30, 2024. showproj.html?proj=227719.

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Vol 287

P. 41-49 - septembre 2025 Retour au numéro
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