LEft Bundle branchArea Pacing to Avoid Pacing-induced CARdiomyopathy
LEAP-CAR
1 other identifier
interventional
130
1 country
1
Brief Summary
LEAP-CAR will evaluate the benefit of left bundle branch area pacing (LBBAP), comparing to conventional right ventricular pacing (RVP), in preventing pacing-induced cardiomyopathy (PICM) in patients undergoing pacemaker implant for advanced (2° or 3° degree) atrioventricular block, with baseline left ventricular ejection fraction (LVEF) \>45%. LEAP-CAR is a randomized, prospective, double blind clinical trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2023
CompletedStudy Start
First participant enrolled
June 10, 2023
CompletedFirst Posted
Study publicly available on registry
June 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2026
ExpectedJanuary 30, 2024
January 1, 2024
2 years
June 9, 2023
January 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absolute and relative value of LVEF (left ventricular ejection fraction) difference between two arms at follow-up
comparison of LVEF by transthoracic echocardiography at 12 months between the two arms (LBBAP vs RV pacing).
1 year
Secondary Outcomes (7)
success rate
1 year
Distance covered at 6'WT (meters)
1 year
Score of quality of life (n: Higher value = worst outcome)
1 year
Intra-patient evolution of LVEF
1 year
Intra-patient evolution of 6'WT (meters difference)
1 year
- +2 more secondary outcomes
Other Outcomes (1)
Heart failure hospitalization and mortality
2 years
Study Arms (2)
Left bundle branch area pacing (LBBAP)
EXPERIMENTALImplant of the ventricular lead of the pacemaker in the left bundle branch area
Right ventricular pacing (RVP)
ACTIVE COMPARATORImplant of the ventricular lead of the pacemaker in a conventional site for pacing (apex/paraapical interventricular septum)
Interventions
Pacing of the conduction system of the heart to obtain physiological activation
Eligibility Criteria
You may qualify if:
- advanced AVB (frequent 2° degree or 3° degree AVB, atrial fibrillation - AF - with advanced AV block) and preserved or slightly reduced LVEF (\>45%)
You may not qualify if:
- LVEF ≤45%
- signs or symptoms of heart failure at enrollment
- unstable angina or acute coronary syndrome \<3 months
- percutaneous coronary intervention or coronary-artery bypass surgery \<3 months
- life expectancy \<6 months
- previous hospitalization for heart failure
- evidence of pulmonary artery hypertension of any origin
- valvular disease greater than moderate
- previous heart transplant pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital "Maggiore della Carità", Division of Cardiology
Novara, 28100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Electrophysiology Unit
Study Record Dates
First Submitted
June 9, 2023
First Posted
June 20, 2023
Study Start
June 10, 2023
Primary Completion
June 10, 2025
Study Completion (Estimated)
June 10, 2026
Last Updated
January 30, 2024
Record last verified: 2024-01