Comparing two types of cardiac pacing for patients with AV conduction disorders
Permanent Left Ventricular Septal Pacing Versus Right Ventricular Pacing in Patients With Atrioventricular Conduction Disorders: a Randomized Trial: LEAP Trial
NA · Maastricht University · NCT04595487
This study is testing if a new way of pacing the heart called left ventricular septal pacing can help people with AV conduction disorders feel better than the traditional method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 470 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maastricht University (other) |
| Locations | 13 sites (Genk and 12 other locations) |
| Trial ID | NCT04595487 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of left ventricular septal pacing (LVSP) compared to traditional right ventricular pacing (RVP) in patients with atrioventricular (AV) conduction disorders. It is a multi-center, randomized controlled trial involving 470 patients who require pacemaker implantation. The study aims to determine if LVSP can provide better outcomes by reducing the adverse effects associated with RVP, such as pacing-induced cardiomyopathy. Participants will be randomly assigned to receive either LVSP or RVP, and their progress will be monitored to assess the primary endpoints.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a class I or IIa indication for pacemaker implantation due to AV conduction disorders and an expected ventricular pacing percentage greater than 20%.
Not a fit: Patients with advanced heart failure, significant valvular heart disease, or those requiring hemodialysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved heart function and quality of life for patients with AV conduction disorders.
How similar studies have performed: While the approach of LVSP is emerging, similar studies have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18y * Life expectancy with good functional status of \> 1y * Class I or IIa pacemaker indication due to AV conduction disorder * Acquired 3rd or 2nd degree AVB * Atrial arrhythmia with slow ventricular conduction * Expected ventricular pacing percentage \> 20% * LVEF \>/= 40% * Signed and dated informed consent form Exclusion Criteria: * HF NYHA class III-IV * Class I indication for CRT * Class I indication for ICD * Previous implanted CIED (except for ILR) * Atrial arrhythmia with planned AV junction ablation * PCI or CABG \<30 days before enrollment * Valvular heart disease with indication for valve repair or replacement * Hypertrophic cardiomyopathy with interventricular septum thickness \> 2 cm * Renal insufficiency requiring hemodialysis * Active infectious disease or malignancy * Pregnancy
Where this trial is running
Genk and 12 other locations
- Ziekenhuis Oost Limburg — Genk, Belgium (NOT_YET_RECRUITING)
- University Hospital Gent — Gent, Belgium (NOT_YET_RECRUITING)
- University Hospital Kralovske Vinohrady — Praha, Czechia (RECRUITING)
- Policlinico Casilino — Rome, Italy (NOT_YET_RECRUITING)
- Maastricht University — Maastricht, Limburg, Netherlands (RECRUITING)
- Noordwest Ziekenhuisgroep — Alkmaar, Netherlands (RECRUITING)
- Reinier de Graaf Gasthuis — Delft, Netherlands (RECRUITING)
- Catharina Ziekenhuis — Eindhoven, Netherlands (RECRUITING)
- Medisch Spectrum Twente — Enschede, Netherlands (RECRUITING)
- Sint Antonius Ziekenhuis — Nieuwegein, Netherlands (RECRUITING)
- University Hospital Jaegellonian — Kraków, Poland (NOT_YET_RECRUITING)
- Hospital Universitario y Politecnico La Fe — Valencia, Spain (NOT_YET_RECRUITING)
- University Hospital of Geneva — Geneva, Switzerland (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Justin Luermans, MD PhD — Department of Cardiology
- Study coordinator: Justin Luermans, MD PhD
- Email: justin.luermans@mumc.nl
- Phone: +31433875093
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiac Pacing, Pacing-Induced Cardiomyopathy, Conduction System Pacing, Left Ventricular Septal Pacing, Atrioventricular Block