Comparative Study to Examine Whether Echocardiography Performed During Cardiac Resynchronization Therapy Device Implantation Can Improve the Response Rate

Study Overview
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Brief Summary
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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.

Official Title
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OPTimization of Left-Ventricular Lead Implantation by Echocardiography- E-OPT Study

Conditions
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Heart Failure, Cardiac Resynchronization Therapy, Echocardiography

Intervention / Treatment
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* Device: Empirical group
* Device: Echocardiography-guided approach


Participation Criteria
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Eligibility Criteria
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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 80. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Empirical<br>Empirical implantation of the left ventricular lead during cardiac resynchronization therapy device implantation | Device: Empirical group<br>* Empirical implantation of the left ventricular lead during cardiac resynchronization therapy device implantation<br>|
| Experimental: Echocardiography-guided approach<br>Echocardiography-guided implantation of the left ventricular lead during cardiac resynchronization therapy device implantation | Device: Echocardiography-guided approach<br>* Echocardiography-guided implantation of the left ventricular lead during cardiac resynchronization therapy device implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response (Improvement in functional class status by at least one NYHA Class or ≥10% increase in 6-minute hall walk distance) to CRT |  | 6 months after device implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |