Non-invasive Electrocardiographic Imaging of SyncAV with MPP: Understanding Optimized Programming for Cardiac Resynchronization Therapy

Non-invasive Electrocardiographic Imaging of SyncAV with MPP: Understanding Optimized Programming for Cardiac Resynchronization Therapy - ECGi of SyncAV with MPP

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54206

Enrollment

Registered

2021-03-17

Start date

2021-09-29

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrhythmias Cardiac Resynchronisation Therapy

Interventions

ECGi Data Collection Visit where device interrogation will be performed including: • Pacing system information and parameters (impedance, sensing amplitudes, and programmed pacing settings) • Recor

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients must meet ALL of the inclusion criteria to be considered for the clinical investigation. 1. Patients previously implanted with a SyncAV and MPP-enabled Abbott Quadripolar CRT pacing system. 2. Patient must be > 18 years of age, able to provide informed consent and willing to comply with study requirements 3. Sinus (or atrial paced) rhythm with intact AV conduction with PR interval

Exclusion criteria

Exclusion criteria: Subjects will be excluded from enrollment if they meet any of the below exclusion criteria: 1. Resting heart rate > 100 bpm 2. AV Block (1st degree with PR> 250 ms, 2nd or 3rd degree) 3. 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 4. Recent (

Design outcomes

Primary

Measure	Time frame
The primary endpoint is acute reduction in the left ventricular activation time (LVAT) and the standard deviation of activation times (SDAT) measured with ECGi resulting from various CRT pacing configurations with MPP and SyncAV.	—

Secondary

Measure	Time frame
Secondary endpoints are: • Correlation between patient baseline characteristics, including LV size, and LV electrical activation time during various CRT pacing configurations with MPP and SyncAV. • Correlation between traditional surface ECG-based QRS duration narrowing and ECGi measured LVAT and SDAT reduction and relationship to CRT device IEGM-based surrogates of activation. • Relationship between scar location assessed with MRI and LV electrical activation pattern during various CRT pacing configurations with MPP and SyncAV. • Acute reduction in the right ventricular activation time (RVAT) and the mean and standard deviation of activation times (SDAT) measured with ECGi resulting from various CRT pacing configurations with MPP and SyncAV.	—

Measure

Time frame

Secondary endpoints are: • Correlation between patient baseline characteristics, including LV size, and LV electrical activation time during various CRT pacing configurations with MPP and SyncAV. • Correlation between traditional surface ECG-based QRS duration narrowing and ECGi measured LVAT and SDAT reduction and relationship to CRT device IEGM-based surrogates of activation. • Relationship between scar location assessed with MRI and LV electrical activation pattern during various CRT pacing configurations with MPP and SyncAV. • Acute reduction in the right ventricular activation time (RVAT) and the mean and standard deviation of activation times (SDAT) measured with ECGi resulting from various CRT pacing configurations with MPP and SyncAV.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)