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NCT06444386 Clinical Trial

ECGi of SyncAV With MultiPoint Pacing

Cardiac Resynchronization Therapy Clinical Trial

Official title:
Electrocardiographic Imaging of MultiPoint Pacing and SyncAV: Understanding Optimized Programming for Cardiac Resynchronization Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06444386
Other study ID # ABT-CIP-10292
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 29, 2021
Est. completion date April 1, 2024

Study information
Verified date June 2024
Source Abbott Medical Devices
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective of this clinical study was to evaluate the impact of Multipoint Pacing (MPP) and SyncAV programming on ventricular electrical activation time and activation sequence using noninvasive electrocardiographic imaging (ECGi) in patients receiving cardiac resynchronization therapy (CRT).

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date April 1, 2024
Est. primary completion date July 12, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients previously implanted with a SyncAV and MPP-enabled Abbott Quadripolar CRT pacing system - Patient must be > 18 years of age, able to provide informed consent and willing to comply with study requirements - Sinus (or atrial paced) rhythm with intact AV conduction with PR interval = 250 ms - Patient has documented Left Bundle Branch Block (LBBB) 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 - 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

Study Design

Related Conditions & MeSH terms

  • Cardiac Resynchronization Therapy

Intervention

Device:
• MPP + SyncAV
Cardiac resynchronization therapy (CRT) features of MultiPoint Pacing (MPP) and SyncAV (dynamic atrioventricular delay programming) enabled.

Locations
Country Name City State
United States Abbott Sylmar California

Sponsors (1)
Lead Sponsor Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Left ventricular activation time Evaluate acute changes in left ventricular (LV) electrical activation time measured with ECGi resulting from various CRT pacing configurations with MPP and SyncAV 1 day
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