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

Completed

Conditions: Cardiac Arrhythmias
Cardiac Resynchronisation Therapy
10019280

Registration Number: NL-OMON54206

Lead Sponsor: St. Jude Medical

Brief Summary: Trial ended prematurely

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

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 <=
250 ms
4. Patient has documented Left Bundle Branch Block (LBBB)

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 (< 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
5. Women who are pregnant or plan to become pregnant during the study course

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is acute reduction in the left ventricular activation time<br /><br>(LVAT) and the standard deviation of activation times (SDAT) measured with ECGi<br /><br>resulting from various CRT pacing configurations with MPP and SyncAV. </p><br>

Secondary Outcome Measures

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