NCT01014000
Withdrawn
N/A
OPTimization of Left-Ventricular Lead Implantation by Echocardiography- E-OPT Study
Princess Margaret Hospital, Hong Kong1 site in 1 countryJune 2015
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Princess Margaret Hospital, Hong Kong
- Locations
- 1
- Primary Endpoint
- Clinical response (Improvement in functional class status by at least one NYHA Class or ≥10% increase in 6-minute hall walk distance) to CRT
- Status
- Withdrawn
- Last Updated
- 10 years ago
Overview
Brief Summary
Empirical implantation of the left ventricular lead is the prevailing practice in cardiac resynchronization therapy device implantation. The response rate to the therapy has been uniformly 70% only despite various methods to screen patients before device implantation. This study tested the hypothesis that echocardiography to assess acute resynchronization of the left ventricle during device implantation may improve the response rate to the therapy.
Investigators
Ngai Yin Chan
Dr
Princess Margaret Hospital, Hong Kong
Eligibility Criteria
Inclusion Criteria
- •Patients with SR or AF, indicated for CRT procedures (NYHA Class III or ambulatory Class IV despite optimal medical therapy, QRSd≥120ms and LVEF≤35%)
- •Patients with ischaemic or non-ischaemic cardiomyopathy can be recruited
Exclusion Criteria
- •Patients already implanted with an implantable cardiac device, undergoing device upgrade or generator replacement
- •Patients who aged less than 18 or over
- •Patients who are pregnant.
- •Patients who cannot give informed consent.
- •Patients who are judged to have severe mental impairment and cannot report symptoms of heart failure during follow-up.
- •Patients who have comorbid congenital heart disease.
- •Patients who have severe valvular heart disease, apart from severe mitral regurgitation.
- •Patients who have unstable angina or who are within 1 month of myocardial infarction.
- •Patients who have severe lung disease and accurate clinical assessment for heart failure symptoms cannot be performed.
- •Patients who have poor echocardiographic windows precluding reliable echocardiographic examination during baseline assessment, CRT procedures or follow-up.
Outcomes
Primary Outcomes
Clinical response (Improvement in functional class status by at least one NYHA Class or ≥10% increase in 6-minute hall walk distance) to CRT
Time Frame: 6 months after device implantation
Secondary Outcomes
- Echocardiographic response of ≥15% reduction in LVESV(6 months after device implantation)
- Echocardiographic response of absolute increase of ≥5% in LVEF(6 months after device implantation)
- Biochemical response with reduction of BNP level≥15%(6 months after device implantation)
Study Sites (1)
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