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OpenTrials
Completed

NCT Number: NCT06444386

ECGi of SyncAV With MultiPoint Pacing

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).

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Key information

Conditions

Cardiac Resynchronization Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Abbott

Sylmar, California, 91342, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MPP + SyncAV

Device

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

Primary outcomes

  1. Left ventricular activation time

    Time frame: 1 day

    Evaluate acute changes in left ventricular (LV) electrical activation time measured with ECGi resulting from various CRT pacing configurations with MPP and SyncAV

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jun 5, 2024
Registry last updated
Jun 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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