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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
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Abbott Medical Devices

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.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, two-arm, randomized 1:1, multicenter study
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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%.

  2. Electrical resynchronization [ Time Frame: intraoperative ]
    Acute changes in surface ECG QRS duration resulting from various CRT and SyncAV pacing configurations.


Other Outcome Measures:
  1. 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

  2. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Locations
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Canada
Montreal Heart Institute
Montreal, Canada
France
CHU Rennes
Rennes, France
Italy
Policlinico Casilino
Roma, Italy
United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
St. Bartholomew's Hospital
London, United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom
Sponsors and Collaborators
Abbott Medical Devices
Abbott
Investigators
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Principal Investigator: Bernarnd Thibault, MD Montreal Heart Institute
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03567096    
Other Study ID Numbers: SJM-CIP-10231
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: October 4, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No participant data will be shared to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Abbott Medical Devices:
Cardiac resynchronization therapy
MultiPoint Pacing
Additional relevant MeSH terms:
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Bundle-Branch Block
Heart Diseases
Cardiovascular Diseases
Heart Block
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes