High Degree Second Degree Atrioventricular BlockRAFT-TAVR PACENCT06857201
RAFT-TAVR PACE: LBBAP vs. RVP Post-TAVR in Patients Requiring PPI
A study testing Left Bundle Branch Area Pacing and Right Ventricular Pacing in people with High Degree Second Degree Atrioventricular Block and Complete Heart Block, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Degree Second Degree Atrioventricular Block, Complete Heart Block, Heart Failure
- What is being tested?
- Left Bundle Branch Area Pacing and Right Ventricular Pacing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 16 Apr 2026to 16 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
About this study
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
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.
Read the 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
- High Degree Second Degree Atrioventricular Block, Complete Heart Block, Heart Failure, Transcatheter Aortic Valve Replacement (TAVR), Conduction Disorder
- Being tested
- Left Bundle Branch Area Pacing, Right Ventricular Pacing
- 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
- Medical subject headings
- Heart Failure, Arrhythmias, Cardiac, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left Bundle Branch Area PacingProcedure or surgery
LBBAP is performed during permanent pacemaker implantation post-TAVR.
Right Ventricular PacingProcedure or surgery
RVP is performed during permanent pacemaker implantation post-TAVR.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Right Ventricular Pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: enrollment to 3 month FU timepoint
Secondary outcomes (6)
CV Mortality
Compare the incidence of cardiovascular mortality between the LBBAP and RVP groups over the entire follow-up period of the study.
Measured: at least 12 months until 4 years when the study is complete and all data is collected for the last participant
Heart Failure Events
Compare the incidence of heart failure events, including heart failure hospitalizations, between the LBBAP and RVP groups during the entire follow-up period.
Measured: 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
Measured: enrollment to end of study completion, an average of 5 years
Change of NT-proBNP
Change of NT-proBNP from baseline
Measured: 1 year
Left Ventricular Ejection Fraction (LVEF)
Measure and compare changes in LVEF between LBBAP and RVP groups using echocardiographic assessments.
Measured: 1 year
Quality of Life Assessment Change - EQ5D
Change of Quality-of-Life assessment EQ5D from baseline
Measured: from baseline enrollment to end of study, average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start16 Apr 2026 (estimated)
- Primary completion16 Apr 2026 (estimated)
- Study completion16 Apr 2026 (estimated)
Why it stopped: not enough participating site interest
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Degree Second Degree Atrioventricular BlockStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Habib Khan, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857201
- Sponsor's protocol ID
- 5143
- Acronym
- RAFT-TAVR PACE
- Status last verified
- Apr 2026
- First submitted
- 6 Feb 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06857201
- Acronym / sponsor ID
- RAFT-TAVR PACE / 5143
- 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
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: not enough participating site interest
- Enrolment
- 0 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 16 Apr 2026 (estimated)
- Primary completion
- 16 Apr 2026 (estimated)
- Study completion
- 16 Apr 2026 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left Bundle Branch Area Pacing (LBBAP) Group | Experimental | Procedure: Left Bundle Branch Area PacingParticipants 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 | Procedure: Right Ventricular PacingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Left Bundle Branch Area PacingLBBAP is performed during permanent pacemaker implantation post-TAVR. | Procedure or surgery | Left Bundle Branch Area Pacing (LBBAP) Group |
| Right Ventricular PacingRVP is performed during permanent pacemaker implantation post-TAVR. | Procedure or surgery | Right Ventricular Pacing (RVP) Group |
Primary outcome
CV Mortality and Heart Failure Events
Time frame: from enrollment to the 12 month FU at minimum, with data collected every 6 months after until study completion at 5 year mark
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.
Successful Enrollment and Randomization
Time frame: from start of enrollment to end of vanguard/pilot phase of study, enrolling 60 patients
(1) Successfully enroll and randomize 60 patients in 9 months from 6 participating centers
VANGUARD - Successful implantation of devices
Time frame: Vanguard phase - from enrollment to the 60th patient being enrolled and followed up at 12 month FU point
(2) Successfully implant the devices in 60 randomized patients, defined as <10% inability to implant LBBAP lead in those randomized to have LBBAP
VANGUARD - at least 90% ventricular pace at 3 months follow up
Time frame: enrollment to 3 month FU timepoint
>90% ventricular pace in these 60 patients at 3 months follow-up
6 secondary outcomes
CV Mortality
Time frame: at least 12 months until 4 years when the study is complete and all data is collected for the last participant
Heart Failure Events
Time frame: minimum 1 year to end of study completion, average of 5 years
Quality of Life Assessment Change
Time frame: enrollment to end of study completion, an average of 5 years
Change of NT-proBNP
Time frame: 1 year
Left Ventricular Ejection Fraction (LVEF)
Time frame: 1 year
Quality of Life Assessment Change - EQ5D
Time frame: from baseline enrollment to end of study, average of 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Left Bundle Branch Area Pacing and Right Ventricular Pacing in people with High Degree Second Degree Atrioventricular Block and Complete Heart Block, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CV Mortality and Heart Failure Events (time frame: from enrollment to the 12 month FU at minimum, with data collected every 6 months after until study completion at 5 year mark). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.