ECG Belt for CRT Response

Completed

Conditions: desynchronization
heart failure
10019280

Registration Number: NL-OMON48164

Lead Sponsor: Medtronic BV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

Indicated for CRT, with QRS duration >=130 ms, and planned to be implanted with
a market-released Medtronic CRT device and meets at least one of the following
criteria:
o QRS duration < 150 ms
o Prior documented Myocardial Infarction
o Non-LBBB

Exclusion Criteria

Permanent/persistent AF or presenting with AF

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Demonstrate benefit of using the ECG Belt Research System on reducing left<br /><br>ventricular end-systolic volume (LVESV) from baseline to 6 months post-implant<br /><br>compared to standard CRT.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To estimate the benefit of using the ECG Belt Research System on LVEF compared<br /><br>to standard CRT.<br /><br>2. To estimate the benefit of using the ECG Belt Research System on change in<br /><br>quality of life compared to standard CRT.<br /><br>3. To estimate the benefit of using the ECG Belt Research System on change in<br /><br>Six-Minute Walk Test distance compared to standard CRT.<br /><br>4. To estimate the benefit of using the ECG Belt Research System on the<br /><br>Clinical Composite Score compared to standard CRT.<br /><br>5. To characterize ECG Belt Research System-related AEs.<br /><br>6. To assess the changes in LVESV from 6-9 months between subjects who have and<br /><br>have not used the ECG Belt Research System at 6 months.<br /><br>7. To assess the extent of ECG Belt Research System guided programming changes<br /><br>across study visits.</p><br>