Not provided
Not provided
Not provided
Not provided
Not provided
not enough participating site interest
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Left Bundle Branch Area Pacing | Procedure | LBBAP is performed during permanent pacemaker implantation post-TAVR. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| CV Mortality | Compare the incidence of cardiovascular mortality between the LBBAP and RVP groups over the entire follow-up period of the study. | at least 12 months until 4 years when the study is complete and all data is collected for the last participant |
| Heart Failure Events |
| Measure | Description | Time Frame |
|---|---|---|
| Device-related hospitalization | Assess the incidence of hospitalizations directly related to the implanted device in both the LBBAP and RVP groups. | 1 year |
| Device Implant-Related Complications | Evaluate the occurrence of device-related complications requiring medical or surgical intervention, including:
|
Inclusion Criteria:
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
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Right Ventricular Pacing | Procedure | RVP is performed during permanent pacemaker implantation post-TAVR. |
|
Compare the incidence of heart failure events, including heart failure hospitalizations, between the LBBAP and RVP groups during the entire follow-up period. |
| minimum 1 year to end of study completion, average of 5 years |
| Quality of Life Assessment Change | Change of Quality-of-Life assessment Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline | enrollment to end of study completion, an average of 5 years |
| Change of NT-proBNP | Change of NT-proBNP from baseline | 1 year |
| Left Ventricular Ejection Fraction (LVEF) | Measure and compare changes in LVEF between LBBAP and RVP groups using echocardiographic assessments. | 1 year |
| Quality of Life Assessment Change - EQ5D | Change of Quality-of-Life assessment EQ5D from baseline | from baseline enrollment to end of study, average of 5 years |
| 1 year |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D001145 | Arrhythmias, Cardiac |
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D014694 | Ventricular Outflow Obstruction |
Not provided
Not provided