Clinical trial NCT01014000: Comparative Study to Examine Whether Echocardiography Performed During Cardiac Resynchronization Therapy Device Implantation Can Improve the Response Rate
Official title: OPTimization of Left-Ventricular Lead Implantation by Echocardiography- E-OPT Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Failure
Cardiac Resynchronization Therapy
Echocardiography
Lead sponsor: Princess Margaret Hospital, Hong Kong
Sponsor class: OTHER_GOV
Collaborators: name: Medtronic
First posted: 2009-11-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical response (Improvement in functional class status by at least one NYHA Class or ≥10% increase in 6-minute hall walk distance) to CRT
timeFrame: 6 months after device implantation
Secondary outcomes:
measure: Echocardiographic response of ≥15% reduction in LVESV
timeFrame: 6 months after device implantation
measure: Echocardiographic response of absolute increase of ≥5% in LVEF
timeFrame: 6 months after device implantation
measure: Biochemical response with reduction of BNP level≥15%
timeFrame: 6 months after device implantation
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Princess Margaret Hospital
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Ngai Yin Chan, MBBS
role: PRINCIPAL_INVESTIGATOR
References: