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

NCT06857201 | Withdrawn DMC

• 1 other identifier: 5143
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Complete Heart Block; Heart Failure; Transcatheter Aortic Valve Replacement (TAVR); Conduction Disorder; High Degree Second Degree Atrioventricular Block

Keywords

Left Bundle Branch Area Pacing (LBBAP); Right Ventricular Pacing (RVP); Transcatheter Aortic Valve Replacement (TAVR); Permanent Pacemaker Implantation (PPI); High-Degree Atrioventricular Block (HDAVB); Complete Heart Block (CHB); Conduction System Pacing (CSP); Heart Failure; cardiovascular mortality; Ventricular Dyssynchrony; Pacing-Induced Cardiomyopathy; Electrophysiology; cardiac pacing; Physiological Pacing; ventricular function; Left Ventricular Ejection Fraction (LVEF); Clinical Outcomes Post-TAVR; Quality of Life (QoL); Aortic Stenosis; Heart Rhythm Disorders

Outcome Measures

Primary Outcomes (4)

• CV Mortality and Heart Failure Events

  The primary outcome of the full-scale RCT is a composite of CV mortality and HF events. All deaths and in-patient/outpatient unscheduled encounters will be adjudicated by a clinical events adjudication committee. HF events are defined as an admission to a healthcare facility for \>24 hours with a diagnosis of worsening HF or worsening HF requiring intravenous HF therapy and ultrafiltration at an urgent or outpatient healthcare facility. The rationale for using CV mortality and HF events as the primary outcome is that pacing therapy will not prevent non-CV deaths. The rationale for including the worsening of HF managed in outpatient facilities is that more patients are managed aggressively with IV diuretics in emergency departments, HF clinics, and infusion centers, avoiding hospitalization. This is accepted by Health Canada, US Food and Drug Administration, and European Medicines Agency.

  from enrollment to the 12 month FU at minimum, with data collected every 6 months after until study completion at 5 year mark

• Successful Enrollment and Randomization

  (1) Successfully enroll and randomize 60 patients in 9 months from 6 participating centers

  from start of enrollment to end of vanguard/pilot phase of study, enrolling 60 patients

• VANGUARD - Successful implantation of devices

  (2) Successfully implant the devices in 60 randomized patients, defined as \<10% inability to implant LBBAP lead in those randomized to have LBBAP

  Vanguard phase - from enrollment to the 60th patient being enrolled and followed up at 12 month FU point

• VANGUARD - at least 90% ventricular pace at 3 months follow up

  \>90% ventricular pace in these 60 patients at 3 months follow-up

  enrollment to 3 month FU timepoint

Secondary Outcomes (6)

• CV Mortality

  at least 12 months until 4 years when the study is complete and all data is collected for the last participant

• Heart Failure Events

  minimum 1 year to end of study completion, average of 5 years

• Quality of Life Assessment Change

  enrollment to end of study completion, an average of 5 years

• Change of NT-proBNP

  1 year

• Left Ventricular Ejection Fraction (LVEF)

  1 year

Other Outcomes (2)

• Device-related hospitalization

  1 year

• Device Implant-Related Complications

  1 year

Study Arms (2)

Left Bundle Branch Area Pacing (LBBAP) Group

EXPERIMENTAL

Participants randomized to receive Left Bundle Branch Area Pacing (LBBAP) after Transcatheter Aortic Valve Replacement (TAVR). This pacing technique aims to preserve physiologic ventricular activation by directly pacing the left bundle branch area.

Procedure: Left Bundle Branch Area Pacing

Right Ventricular Pacing (RVP) Group

ACTIVE COMPARATOR

Participants randomized to receive Right Ventricular Pacing (RVP) after Transcatheter Aortic Valve Replacement (TAVR). This technique is the traditional pacing method, which stimulates the right ventricle to maintain cardiac rhythm.

Procedure: Right Ventricular Pacing

Interventions

Left Bundle Branch Area Pacing PROCEDURE

LBBAP is performed during permanent pacemaker implantation post-TAVR.

Left Bundle Branch Area Pacing (LBBAP) Group

Right Ventricular Pacing PROCEDURE

RVP is performed during permanent pacemaker implantation post-TAVR.

Right Ventricular Pacing (RVP) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Successful insertion of TAVR for aortic stenosis
• Persistent HDAVB or CHB identified within 30 days of TAVR
• ● HDAVB is defined as any of the following(9): Second-degree AV block type 2 (Mobitz II) in the presence of a QRS ≥120 msec, or 2:1 AV block in the presence of a QRS ≥120 msec, or ≥2 consecutive P waves at a constant physiologic rate that do not conduct to the ventricles, or transient third-degree AV block, or in the setting of AF a prolonged pause (\>3 s) or a fixed slow (\<50 beats/min) ventricular response rate.
• Age ≥ 18 years

You may not qualify if:

• 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
• Renal failure - eGFR\<15 or on dialysis
• Un-revascularized coronary artery disease with proximal multi-vascular coronary disease
• Acute coronary syndrome with 3 months
• Cardiogenic shock requiring inotropic therapy within 1 week
• Life-expectancy \< 2 years
• Anticipating heart transplant within 1 year
• Pregnant or intending to become pregnant within the study period
• Participating in another randomized controlled trial
• Unable or unwilling to provide consent

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

MeSH Terms

Conditions

Heart Failure; Arrhythmias, Cardiac; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Habib Khan, Co-Principal Investigator

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: March 4, 2025
• Study Start: April 16, 2026
• Primary Completion: April 16, 2026
• Study Completion: April 16, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04