LV Only MPP With SyncAV

NCT03567096 | Completed

• 1 other identifier: SJM-CIP-10231
• Study Type: interventional
• Target: 101
• Locations: 4 countries
• Sites: 6

Brief Summary

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.

Conditions

Heart Failure; Left Bundle-Branch Block

Keywords

Cardiac resynchronization therapy; MultiPoint Pacing

Outcome Measures

Primary Outcomes (1)

• Clinical response

  Patient clinical response to LV only pacing with SyncAV optimization at six-month follow-up evaluated by the Packer clinical composite score.

  up to 6 months

Secondary Outcomes (2)

• Left Ventricle reverse remodeling

  up to 6 months

• Electrical resynchronization

  intraoperative

Other Outcomes (2)

• Hemodynamic response

  intraoperative

• Left Ventricle Electrical Activation

  intraoperative

Study Arms (2)

BiV+MPP

ACTIVE COMPARATOR

Patients randomized to the "BiV pacing with MPP and SyncAV" study arm will have CRT programming to biventricular pacing with MPP activated. RV-LV pacing delay set to 5 ms, LV1 \& LV2 pacing cathodes selected as the maximal spaced electrodes (D1+P4, D2+M3, M2+P4) with pacing delay set to 5 ms and SyncAV offset programmed providing the optimum electrical resynchronization (shortest QRS duration).

Device: BiV pacing with MPP and SyncAV

LV-only + MPP

EXPERIMENTAL

Patients randomized to the " LV only pacing with MPP and SyncAV" study arm will have CRT programming to left ventricular only pacing with MPP activated. LV1 \& LV2 pacing cathodes selected as the maximal spaced electrodes (D1+P4, D2+M3, M2+P4) with pacing delay set to 5 ms and SyncAV offset programmed providing the optimum electrical resynchronization (shortest QRS duration)

Device: LV only pacing with MPP and SyncAV

Interventions

BiV pacing with MPP and SyncAV DEVICE

This cohort will receive Bi-Ventricular Pacing (left ventricle and right ventricle pacing) with MultiPoint Pacing of the left ventricle (two stimulation sites) and the SyncAV algorithm active.

BiV+MPP

LV only pacing with MPP and SyncAV DEVICE

This cohort will receive left ventricular only pacing (no right ventricle pacing) with MultiPoint Pacing of the left ventricle (two stimulation sites) and the SyncAV algorithm active.

LV-only + MPP

Eligibility Criteria

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

You may qualify if:

• Patients with approved indication for CRT scheduled to be implanted with an MPP-enabled ABT Quadripolar CRT pacing system, de novo or upgrade from non-CRT system
• Patient must be \> 18 years of age, able to provide informed consent and willing to comply with study requirements
• Documented permanent left bundle branch block (LBBB)
• Intrinsic QRS duration ≥ 150 ms
• Sinus (or atrial paced) rhythm with intact AV conduction with PR interval ≤ 250 ms

You may not qualify if:

• Resting heart rate \> 100 bpm
• AV Block (1st degree with PR\> 250 ms, 2nd or 3rd degree)
• Documented persistent atrial tachycardia or atrial fibrillation at the moment of enrollment or patients not likely to remain in sinus (or atrial paced) rhythm for the duration of the study
• Patients scheduled for AV node ablation to treat paroxysmal atrial arrhythmias
• Recent (\< 3 months) myocardial infarction, ablation, electrolyte imbalance, or any condition within the last 90 days that would contraindicate for CRT programming changes in the opinion of the investigator
• Women who are pregnant or plan to become pregnant during the study course

Sponsors & Collaborators

• Abbott Medical Devices: lead
• Abbott: collaborator

Study Sites (6)

Montreal Heart Institute

Montreal, Canada

Location

CHU Rennes

Rennes, France

Location

Policlinico Casilino

Roma, Italy

Location

Queen Elizabeth Hospital

Birmingham, United Kingdom

Location

St. Bartholomew's Hospital

London, United Kingdom

Location

John Radcliffe Hospital

Oxford, United Kingdom

Location

Related Publications (1)

• Thibault B, Waddingham P, Badie N, Mangual JO, McSpadden LC, Betts TR, Calo L, Grieco D, Leyva F, Chow A. Acute Electrical Synchronization Achieved With Dynamic Atrioventricular Delays During Biventricular and Left Ventricular MultiPoint Pacing. CJC Open. 2024 Nov 8;7(2):166-175. doi: 10.1016/j.cjco.2024.11.003. eCollection 2025 Feb.

  PMID: 40060211 DERIVED

MeSH Terms

Conditions

Heart Failure; Bundle-Branch Block

Condition Hierarchy (Ancestors)

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

Study Officials

• Bernarnd Thibault, MD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, two-arm, randomized 1:1, multicenter study

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 25, 2018
• Study Start: October 9, 2018
• Primary Completion: February 24, 2023
• Study Completion: September 30, 2023
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3); IT (1); CA (1); FR (1)