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

Not Applicable

Withdrawn

• Conditions: Echocardiography; Heart Failure; Cardiac Resynchronization Therapy

• Registration Number: NCT01014000
• Lead Sponsor: Princess Margaret Hospital, Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-13
• Study First Submitted QC: 2009-11-13
• Study First Posted: 2009-11-16
• Study Start: 2015-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-03
• Last Update Posted: 2015-09-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. 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%)
2. Patients with ischaemic or non-ischaemic cardiomyopathy can be recruited

Exclusion Criteria

1. Patients already implanted with an implantable cardiac device, undergoing device upgrade or generator replacement
2. Patients who aged less than 18 or over 80.
3. Patients who are pregnant.
4. Patients who cannot give informed consent.
5. Patients who are judged to have severe mental impairment and cannot report symptoms of heart failure during follow-up.
6. Patients who have comorbid congenital heart disease.
7. Patients who have severe valvular heart disease, apart from severe mitral regurgitation.
8. Patients who have unstable angina or who are within 1 month of myocardial infarction.
9. Patients who have severe lung disease and accurate clinical assessment for heart failure symptoms cannot be performed.
10. Patients who have poor echocardiographic windows precluding reliable echocardiographic examination during baseline assessment, CRT procedures or follow-up.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Princess Margaret Hospital; 🇨🇳 Hong Kong, China