ECGi of SyncAV With MultiPoint Pacing

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

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).

Study Overview

• Status: Completed
• Conditions: Cardiac Resynchronization Therapy
• Intervention / Treatment: Device: MPP + SyncAV

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • California
    • Sylmar, California, United States, 91342
      • Abbott

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The intended population for this clinical investigation consisted of patients over the age of 18 years who have been previously implanted with an Abbott CRT device capable of SyncAV and MultiPoint Pacing. This clinical investigation enrolled male and female subjects from the general heart failure population. Subjects must have met all eligibility criteria and provide written informed consent prior to conducting any investigation-specific procedures not considered standard of care.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2021
• Primary Completion (Actual): July 12, 2023
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Actual): June 5, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ABT-CIP-10292

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No