RAFT-TAVR PACE: LBBAP vs. RVP Post-TAVR in Patients Requiring PPI (NCT06857201) | Clinical Trial Compass
WithdrawnNot Applicable
RAFT-TAVR PACE: LBBAP vs. RVP Post-TAVR in Patients Requiring PPI
Stopped: not enough participating site interest
0Started 2026-04-16
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Successful insertion of TAVR for aortic stenosis
. Persistent HDAVB or CHB identified within 30 days of TAVR
. Age ≥ 18 years
Exclusion criteria
. Patients with a pacemaker/ICD/CRT prior to TAVR
. More than mild para-valvular regurgitation following TAVR
. Patients with clinical indication for CRT-D or CRT-P
. Patients with mechanical tricuspid valve
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
CV Mortality and Heart Failure Events
Timeframe: from enrollment to the 12 month FU at minimum, with data collected every 6 months after until study completion at 5 year mark
2
Successful Enrollment and Randomization
Timeframe: from start of enrollment to end of vanguard/pilot phase of study, enrolling 60 patients
3
VANGUARD - Successful implantation of devices
Timeframe: Vanguard phase - from enrollment to the 60th patient being enrolled and followed up at 12 month FU point
4
VANGUARD - at least 90% ventricular pace at 3 months follow up
Timeframe: enrollment to 3 month FU timepoint
Trial details
NCT IDNCT06857201
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's