Clinical trial NCT06857201: RAFT-TAVR PACE: LBBAP Vs. RVP Post-TAVR in Patients Requiring PPI
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: High Degree Second Degree Atrioventricular Block
Complete Heart Block
Heart Failure
Transcatheter Aortic Valve Replacement (TAVR)
Conduction Disorder
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
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Successful insertion of TAVR for aortic stenosis
2. 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.
3. Age ≥ 18 years

Exclusion Criteria:

1. Patients with a pacemaker/ICD/CRT prior to TAVR
2. More than mild para-valvular regurgitation following TAVR
3. Patients with clinical indication for CRT-D or CRT-P
4. Patients with mechanical tricuspid valve
5. Renal failure - eGFR\<15 or on dialysis
6. Un-revascularized coronary artery disease with proximal multi-vascular coronary disease
7. Acute coronary syndrome with 3 months
8. Cardiogenic shock requiring inotropic therapy within 1 week
9. Life-expectancy \< 2 years
10. Anticipating heart transplant within 1 year
11. Pregnant or intending to become pregnant within the study period
12. Participating in another randomized controlled trial
13. Unable or unwilling to provide consent

Primary outcomes:
measure: 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
measure: Successful Enrollment and Randomization
timeFrame: from start of enrollment to end of vanguard/pilot phase of study, enrolling 60 patients
measure: VANGUARD - Successful implantation of devices
timeFrame: Vanguard phase - from enrollment to the 60th patient being enrolled and followed up at 12 month FU point
measure: VANGUARD - at least 90% ventricular pace at 3 months follow up
timeFrame: enrollment to 3 month FU timepoint
Secondary outcomes:
measure: CV Mortality
timeFrame: at least 12 months until 4 years when the study is complete and all data is collected for the last participant
measure: Heart Failure Events
timeFrame: minimum 1 year to end of study completion, average of 5 years
measure: Quality of Life Assessment Change
timeFrame: enrollment to end of study completion, an average of 5 years
measure: Change of NT-proBNP
timeFrame: 1 year
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: 1 year
measure: Quality of Life Assessment Change - EQ5D
timeFrame: from baseline enrollment to end of study, average of 5 years
Other outcomes:
measure: Device-related hospitalization
timeFrame: 1 year
measure: Device Implant-Related Complications
timeFrame: 1 year
Locations:
Study officials:
References: