Left Bundle Branch Area Pacing or Biventricular Pacing in AF and Left Ventricular Dysfunction

NCT06620705 | Recruiting DMC FDA Device

• 1 other identifier: NL84372.058.23
• Study Type: interventional
• Target: 34
• Locations: 2 countries
• Sites: 2

Brief Summary

It is unknown whether left bundle branch area pacing (LBBAP) or biventricular pacing best prevents or reverses left ventricular (LV) adverse remodelling in patients with atrial fibrillation (AF) who require ventricular pacing or CRT. This randomized non-inferiority cross-over trial will compare left ventricular end-systolic volume change and secondary endpoints between LBBAP and biventricular pacing in patients with AF and LV dysfunction.

Conditions

Heart Failure; Block, Heart; Pacing-Induced Cardiomyopathy

Keywords

pacing; cardiac resynchronization therapy; left bundle branch area pacing; conduction system pacing; heart failure; heart block

Outcome Measures

Primary Outcomes (1)

• Left ventricular end-systolic volume (LVESV) change

  Left ventricular end-systolic volume change measured by echocardiography

  6 months

Secondary Outcomes (10)

• Change in New York Heart Association functional class

  6 months

• Change in Minnesota living with heart failure questionnaire

  6 months

• Change in 6-minute walking distance

  6 months

• Change in QRS duration

  6 months

• Change in vectorcardiographic QRS area

  6 months

Study Arms (2)

Left bundle branch area pacing

EXPERIMENTAL

6 months of left bundle branch area pacing.

Device: Left bundle branch area pacing

Biventricular pacing

ACTIVE COMPARATOR

6 months of biventricular pacing using a RV apex lead and LV lead in the coronary sinus.

Device: Biventricular pacing

Interventions

Left bundle branch area pacing DEVICE

Pacing of the left bundle branch area using a transvenous pacemaker lead

Also known as: Conduction system pacing, Cardiac resynchronization therapy

Left bundle branch area pacing

Biventricular pacing DEVICE

Pacing of the right and left ventricle using transvenous pacemaker leads

Also known as: Cardiac resynchronization therapy

Biventricular pacing

Eligibility Criteria

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

You may qualify if:

• In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Adults ≥18 years with permanent AF and LVEF \< 50% who either require ventricular pacing because of bradycardia including patients undergoing AV junction ablation, or have an indication for cardiac resynchronization therapy.
• Expected percentage of ventricular pacing \> 40%
• ≥ 3 months of heart failure medication optimization
• Of note, patients who already have a device, but require an upgrade to a CRT device, can also be included

You may not qualify if:

• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Age \< 18 years
• Pregnancy or active pregnancy wish
• Not eligible for implantation of an RV lead, LBBAP lead, or LV lead in the coronary sinus
• Recent valve intervention/surgery or acute myocardial infarction (\< 6 months)
• NYHA functional class IV heart failure, left ventricular assist device or cardiac transplant

Sponsors & Collaborators

• srdpiers: lead
• Aarhus University Hospital: collaborator

Study Sites (2)

Aarhus University Hospital

Aarhus N, Aarhus N, DK-8200, Denmark

NOT YET RECRUITING

Leiden University Medical Center

Leiden, South Holland, 2300 RC, Netherlands

RECRUITING

MeSH Terms

Conditions

Heart Failure; Heart Block

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Officials

• Sebastiaan Piers, MD, PhD

  Leiden University Medical Center, Leiden, the Netherlands

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastiaan RD Piers, MD, PhD

CONTACT

+31715262020; s.r.d.piers@lumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient will be blinded to the treatment allocation. The assessor of the ECG endpoints and echocardiographic endpoints will be blinded to the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized patient and assessor blinded non-inferiority cross-over trial.

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: October 1, 2024
• Study Start: September 10, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After completion of the study and publication, the data will be shared with other researchers whenever reasonable and of potential benefit for patients.
• Access Criteria: Whenever reasonable and of potential benefit for patients.

Locations

DK (1); NL (1)