Effect of targeting left ventricular lead position on the rate of response to resynchronisation therapy in patients with Coronary Artery Disease

Not Applicable

Completed

• Conditions: Coronary artery disease; Circulatory System; Chronic ischaemic heart disease

• Registration Number: ISRCTN91938977
• Lead Sponsor: niversity of Calgary (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-06-17
• Study Completion: 2012-03-30
• Last Update Posted: 18 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Left ventricular ejection fraction (LVEF) less than or equal to 0.35 measured within three months of enrolment
2. Specific Activity Scale (SAS) class 3 or 4 symptoms (moderate to severe functional capacity limitation due to heart failure) within 1 month of enrolment
3. QRS width greater than 120 ms
4. Confirmed dyssynchrony on screening echo
5. Documented history of ischaemic heart disease (prior myocardial infarction, prior coronary artery bypass, prior coronary angioplasty, or imaging confirmation [angiogram, cardiac MRI])
6. On stable doses of angiotensin converting enzyme (ACE) inhibitor or angiotensin II blocker and a beta-blocker for greater than or equal to two months unless medically contra-indicated
7. Controlled heart rate if in permanent atrial fibrillation (AF) (resting rate less than 70 and maximal rate less than 120 bpm)
8. Patients aged 18 years or older

Exclusion Criteria

1. Unable or unwilling to provide informed consent
2. Medical condition other than heart failure likely to cause death within 12 months
3. Cardiac transplant planned within six months
4. Known contra-indication to transvenous CRT device implant (e.g., active sepsis, artificial tricuspid valve, known vascular occlusion that will prevent delivery of transvenous leads)
5. Clinically significant myocardial infarction within last two months
6. Coronary artery bypass graft surgery less than or equal to two months or coronary angioplasty less than or equal to one month

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CRT response (greater than or equal to 10% relative reduction in left ventricular end systolic volume and greater than or equal to one Specific Activity Scale class reduction) at 9 months.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Clinical events (mortality and hospitalisation) from implant until 9 months<br> 2. Safety (procedural time, contrast use, fluoroscopy time, procedural complications - minor and severe) from implant until 9 months<br> 3. Pacing efficacy (pacing thresholds) from implant until 9 months<br>