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

Heart Failure Clinical Trial

— E-OPT  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01014000
• Other study ID #: EOPT01
• Status: Withdrawn
• Phase: N/A
• First received: November 13, 2009
• Last updated: September 3, 2015
• Start date: June 2015
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: Princess Margaret Hospital, Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Resynchronization Therapy
• Echocardiography
• Heart Failure

Intervention

Device:
• Empirical group
Empirical implantation of the left ventricular lead during cardiac resynchronization therapy device implantation
• Echocardiography-guided approach
Echocardiography-guided implantation of the left ventricular lead during cardiac resynchronization therapy device implantation

Locations

Country	Name	City	State
China	Princess Margaret Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Princess Margaret Hospital, Hong Kong	Medtronic

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Echocardiographic response of =15% reduction in LVESV		6 months after device implantation	No
Secondary	Echocardiographic response of absolute increase of =5% in LVEF		6 months after device implantation	No
Secondary	Biochemical response with reduction of BNP level=15%		6 months after device implantation	No