LV Only MPP With SyncAV
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|ClinicalTrials.gov Identifier: NCT03567096|
Recruitment Status : Enrolling by invitation
First Posted : June 25, 2018
Last Update Posted : October 4, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Left Bundle-Branch Block||Device: BiV pacing with MPP and SyncAV Device: LV only pacing with MPP and SyncAV||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective, two-arm, randomized 1:1, multicenter study|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Characterization of Acute and Long Term Response to Left Ventricle Only Pacing Combined With MultiPoint Pacing and SyncAV|
|Actual Study Start Date :||October 9, 2018|
|Estimated Primary Completion Date :||June 30, 2023|
|Estimated Study Completion Date :||June 30, 2023|
Active Comparator: BiV+MPP
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
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.
Experimental: LV-only + MPP
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
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.
- Clinical response [ Time Frame: up to 6 months ]Patient clinical response to LV only pacing with SyncAV optimization at six-month follow-up evaluated by the Packer clinical composite score.
- Left Ventricle reverse remodeling [ Time Frame: up to 6 months ]Patient reverse remodeling response to LV only pacing at six-month follow-up defined as end-systolic volume reduction >15%.
- Electrical resynchronization [ Time Frame: intraoperative ]Acute changes in surface ECG QRS duration resulting from various CRT and SyncAV pacing configurations.
- Hemodynamic response [ Time Frame: intraoperative ]Acute changes in LV dP/dtmax (measured with pressure wire, pressure-volume loop catheter or non-invasive system) resulting from various CRT and SyncAV pacing configurations (subset of patients consenting to invasive measurements
- Left Ventricle Electrical Activation [ Time Frame: intraoperative ]Acute changes in LV activation time resulting from various CRT and SyncAV pacing configurations (subset of patients undergoing body surface mapping).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567096
|Montreal Heart Institute|
|Queen Elizabeth Hospital|
|Birmingham, United Kingdom|
|St. Bartholomew's Hospital|
|London, United Kingdom|
|John Radcliffe Hospital|
|Oxford, United Kingdom|
|Principal Investigator:||Bernarnd Thibault, MD||Montreal Heart Institute|