Trials / Not Yet Recruiting

Not Yet RecruitingNCT06857201

RAFT-TAVR PACE: LBBAP Vs. RVP Post-TAVR in Patients Requiring PPI

Randomized Assessment of Left Bundle Branch Area Pacing Versus Right Ventricular Pacing in Post-TAVR Patients with Persistent High-Degree Atrioventricular Block or Complete Heart Block Requiring Permanent Pacemaker Implantation

Status: Not Yet Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 430 (estimated)

Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

The RAFT-TAVR PACE study is a clinical trial designed to compare two types of heart pacing methods in patients who develop conduction problems after undergoing a transcatheter aortic valve replacement (TAVR) procedure. This study will evaluate whether Left Bundle Branch Area Pacing (LBBAP), a newer and more natural pacing method, is better than the traditional Right Ventricular Pacing (RVP) at improving heart function and patient outcomes. The study aims to recruit 60 patients across six centers and will focus on the safety, feasibility, and success of LBBAP compared to RVP. Patients will be followed for one year to assess heart function, quality of life, and any complications related to the pacing method.

Detailed description

The RAFT-TAVR PACE study is a multi-center, double-blind, randomized controlled trial (RCT) designed to compare Left Bundle Branch Area Pacing (LBBAP) and Right Ventricular Pacing (RVP) in patients who develop persistent high-degree atrioventricular block (HDAVB) or complete heart block (CHB) following Transcatheter Aortic Valve Replacement (TAVR). Background \& Rationale: TAVR is an established treatment for severe aortic stenosis, but conduction disturbances requiring permanent pacemaker implantation (PPI) remain a common complication, affecting approximately 15-25% of patients post-TAVR. Conventional RVP has been associated with ventricular dyssynchrony, adverse cardiac remodeling, and increased risk of heart failure. LBBAP is an emerging conduction system pacing technique that may preserve physiological ventricular activation by engaging the His-Purkinje system more effectively. While observational studies suggest LBBAP may improve ventricular function, quality of life, and clinical outcomes compared to RVP, no large-scale RCT has yet validated these benefits in post-TAVR patients requiring PPI. Study Objectives: Primary Objective: Assess the feasibility and success rate of LBBAP implantation in post-TAVR patients requiring PPI and determine if LBBAP results in improved outcomes over RVP. Secondary Objectives: Evaluate the impact of LBBAP versus RVP on: Left ventricular activation Left ventricular ejection fraction (LVEF) Quality of life (KCCQ, EQ-5D-5L) Heart failure events and adverse clinical outcomes Study Design: The Vanguard Phase will enroll 60 patients across six sites over nine months to establish the feasibility, procedural success, and safety of LBBAP. If successful, the study will expand into a full-scale RCT. Randomization (1:1) occurs after the clinical decision to implant a pacemaker post-TAVR. Blinding: The study is double-blinded-patients and follow-up clinicians are blinded to pacing allocation. The implanting physician is unblinded for procedural purposes. Follow-up Duration: 12 months, with scheduled assessments at 3, 6, and 12 months, including pacemaker interrogation, echocardiography, and quality-of-life questionnaires. Key Endpoints: Primary Endpoint: Feasibility of recruitment (60 patients in 9 months) LBBAP implantation success rate \>90% Secondary Endpoints: Improvement in left ventricular activation LVEF at 12 months Quality of life (KCCQ, EQ-5D-5L) changes Rates of heart failure hospitalization and adverse events Safety \& Data Monitoring: An independent Data and Safety Monitoring Board (DSMB) will oversee patient safety. Adverse events will be adjudicated by a blinded committee and reported per regulatory guidelines. Data collection will be managed through a secure REDCap database. Significance: This study will generate critical evidence to determine whether LBBAP should be the preferred pacing modality for post-TAVR patients requiring PPI. If proven superior, LBBAP could redefine post-TAVR pacing guidelines, improving patient outcomes and quality of life.

Conditions

Interventions

Type	Name	Description
PROCEDURE	Left Bundle Branch Area Pacing	LBBAP is performed during permanent pacemaker implantation post-TAVR.
PROCEDURE	Right Ventricular Pacing	RVP is performed during permanent pacemaker implantation post-TAVR.

Timeline

Start date: 2025-04-01
Primary completion: 2025-09-26
Completion: 2028-12-31
First posted: 2025-03-04
Last updated: 2025-03-04

Source: ClinicalTrials.gov record NCT06857201. Inclusion in this directory is not an endorsement.