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Cardiac Resynchronization Therapy

LV Only Pacing and BiV Pacing for Heart Failure

N/A
Waitlist Available
Led By Bernarnd Thibault, MD
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights

Study Summary

This trial is designed to study whether left ventricle (LV) only pacing combined with automatic adjustment of AV timing (SyncAV) is more effective than bi-ventricular pacing with multipoint pacing (MPP) and SyncAV in patients receiving cardiac resynchronization therapy (CRT), after 6 months of therapy. Approximately 120 subjects will be enrolled at 7 centers in Europe and Canada, and data will be collected at enrollment, CRT implant procedure, hospital pre-discharge, one and 6 months post implant.

Eligible Conditions
  • Heart Failure
  • Left Bundle Branch Block

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical response
Secondary outcome measures
Electrical resynchronization
Left Ventricle reverse remodeling
Other outcome measures
Hemodynamic response
Left Ventricle Electrical Activation

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: LV-only + MPPExperimental Treatment1 Intervention
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)
Group II: BiV+MPPActive Control1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LV only pacing with MPP and SyncAV
2018
N/A
~110

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
638 Previous Clinical Trials
404,395 Total Patients Enrolled
124 Trials studying Heart Failure
51,895 Patients Enrolled for Heart Failure
AbbottIndustry Sponsor
751 Previous Clinical Trials
478,074 Total Patients Enrolled
20 Trials studying Heart Failure
5,962 Patients Enrolled for Heart Failure
Bernarnd Thibault, MDPrincipal InvestigatorMontreal Heart Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings remaining in this research program?

"As indicated on clinicaltrials.gov, this study has ceased its recruitment efforts as of October 3rd 2022 - the date of its most recent update since being first posted in 2018. However, 707 other trials are currently offering participation at present."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
LV Only MPP With SyncAV
2018. "LV Only MPP With SyncAV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03567096.
~16 spots leftby Apr 2025
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