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.

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. https://www.chictr.org.cn/showproj.html?proj=227719.