NCT03567096

LV Only MPP With SyncAV

Completed NA Last updated 21 February 2025

What this trial tests

NA trial testing BiV pacing with MPP and SyncAV in Heart Failure in 101 participants. Completed in 30 September 2023.

Timeline

9 October 2018

Primary endpoint
24 February 2023

30 September 2023

Quick facts

Lead sponsor	Abbott Medical Devices
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	101
Start date	9 October 2018
Primary completion	24 February 2023
Estimated completion	30 September 2023
Sites	6 locations across France, Canada, United Kingdom, Italy

Drugs / interventions tested

• BiV pacing with MPP and SyncAV
• LV only pacing with MPP and SyncAV

Conditions studied

• Heart Failure — all drugs for Heart Failure →
• Left Bundle-Branch Block — all drugs for Left Bundle-Branch Block →

Sponsor

Abbott Medical Devices — full company profile →

Who can join

18 and older, any sex, with Heart Failure or Left Bundle-Branch Block. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of this clinical investigation is to evaluate the clinical benefits of left ventricle (LV) only pacing combined with automatic adjustment of AV timing (SyncAV) in patients receiving cardiac resynchronization therapy (CRT) after 6 months of therapy.

This clinical investigation is a prospective, two-arm, randomized 1:1, multicenter feasibility study designed to evaluate the effectiveness of LV only with multipoint pacing (MPP) and SyncAV compared to bi-ventricular pacing with MPP and SyncAV. The clinical investigation will be conducted at approximately 7 centers in Europe and Canada. Approximately 120 subjects will be enrolled in the study. No site may enroll more than 33% of the total subjects.

Data will be collected at enrollment, CRT implant procedure, hospital pre-discharge, one and 6 months post implant. Enrollment data collection will include demographics, cardiovascular history, medication, echocardiography measurements and quality of life questionnaire. CRT implant procedure data collection will include implanted system information and lead location. The electrical conduction recording procedure will include surface ECG and device IEGM recordings during various pacing configurations at implant or up to 45 days post implant. In patients who consent to invasive measurements (expected target of at least 80 patients), a hemodynamic recording procedure will include invasive hemodynamic measurements during various pacing configurations which may take place during device implant or up to 45 days post implant. Hospital pre-discharge data collection will take place within 3 days after the CRT implant, electrical conduction recordings visit or hemodynamic recordings visit and will include system information, surface ECG, and device IEGMs.

In a subset of patients from selected centers that have access to this technology (expected 20 patients), non-invasive electrical activation data will be collected with body surface mapping within 45 days of the implant procedure.

Patients will be randomized 1:1 to receive either biventricular pacing with multipoint pacing (MPP) or LV-only pacing with MPP at the one-month (± 15 days) visit. The 6-month (± 15 days) post randomization follow up visit will include surface ECG, IEGMs, echocardiographic parameters and quality of life questionnaire.

Subjects participating in this clinical investigation will follow the hospital center standard of care from implant to 6 month follow up. The expected duration of enrollment is 1.5 year. The total duration of the clinical investigation is expected to be 2 years.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Fusion Pacing with Biventricular, Left Ventricular-only and Multipoint Pacing in Cardiac Resynchronisation Therapy: Latest Evidence and Strategies for Use.
   Waddingham PH, Lambiase P, Muthumala A, Rowland E, et al · · 2021 · cited 13× · PMID 34401181 · DOI 10.15420/aer.2020.49
2. Electrocardiographic imaging demonstrates electrical synchrony improvement by dynamic atrioventricular delays in patients with left bundle branch block and preserved atrioventricular conduction.
   Waddingham PH, Mangual JO, Orini M, Badie N, et al · · 2023 · cited 12× · PMID 36480445 · DOI 10.1093/europace/euac224
3. Progress in Cardiac Resynchronisation Therapy and Optimisation.
   Akhtar Z, Gallagher MM, Kontogiannis C, Leung LWM, et al · · 2023 · cited 2× · PMID 37887875 · DOI 10.3390/jcdd10100428
4. Acute Electrical Synchronization Achieved With Dynamic Atrioventricular Delays During Biventricular and Left Ventricular MultiPoint Pacing.
   Thibault B, Waddingham P, Badie N, Mangual JO, et al · · 2025 · cited 1× · PMID 40060211 · DOI 10.1016/j.cjco.2024.11.003
5. Noninvasive electrocardiographic imaging of dynamic atrioventricular delay programming in a patient with left bundle branch block.
   Waddingham PH, Mangual J, Orini M, Badie N, et al · · 2021 · cited 1× · PMID 34987974 · DOI 10.1016/j.hrcr.2021.09.009
6. Left Ventricular and Biventricular Multipoint Pacing With Dynamic Atrioventricular Delays: 6-Month Cardiac Resynchronization Therapy Response.
   Thibault B, Waddingham P, Badie N, Mangual JO, et al · · 2026 · PMID 41755392 · DOI 10.1111/jce.70294