Comparative Study to Examine Whether Echocardiography Performed During Cardiac Resynchronization Therapy Device Implantation Can Improve the Response Rate (E-OPT)
This study is not yet open for participant recruitment.
Verified March 2013 by Princess Margaret Hospital, Hong Kong
Sponsor:
Princess Margaret Hospital, Hong Kong
Collaborator:
Medtronic
Information provided by (Responsible Party):
Ngai Yin Chan, Princess Margaret Hospital, Hong Kong
ClinicalTrials.gov Identifier:
NCT01014000
First received: November 13, 2009
Last updated: March 24, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Heart Failure Cardiac Resynchronization Therapy Echocardiography |
Device: Empirical group Device: Echocardiography-guided approach |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | OPTimization of Left-Ventricular Lead Implantation by Echocardiography- E-OPT Study |
Resource links provided by NLM:
Further study details as provided by Princess Margaret Hospital, Hong Kong:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Echocardiographic response of ≥15% reduction in LVESV [ Time Frame: 6 months after device implantation ] [ Designated as safety issue: No ]
- Echocardiographic response of absolute increase of ≥5% in LVEF [ Time Frame: 6 months after device implantation ] [ Designated as safety issue: No ]
- Biochemical response with reduction of BNP level≥15% [ Time Frame: 6 months after device implantation ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 70 |
| Study Start Date: | December 2013 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Empirical
Empirical implantation of the left ventricular lead during cardiac resynchronization therapy device implantation
|
Device: Empirical group
Empirical implantation of the left ventricular lead during cardiac resynchronization therapy device implantation
|
|
Experimental: Echocardiography-guided approach
Echocardiography-guided implantation of the left ventricular lead during cardiac resynchronization therapy device implantation
|
Device: Echocardiography-guided approach
Echocardiography-guided implantation of the left ventricular lead during cardiac resynchronization therapy device implantation
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01014000
Contacts
| Contact: Ngai Yin Chan, MBBS | 852 29903725 ext 3725 | ngaiyinchan@yahoo.com.hk |
Locations
| China | |
| Princess Margaret Hospital | Not yet recruiting |
| Hong Kong, China, 852 | |
| Contact: Ngai Yin Chan, MBBS 852 29903725 ext 3725 ngaiyinchan@yahoo.com.hk | |
Sponsors and Collaborators
Princess Margaret Hospital, Hong Kong
Medtronic
Investigators
| Principal Investigator: | Ngai Yin Chan, MBBS | Princess Margaret Hospital, Canada |
More Information
No publications provided
| Responsible Party: | Ngai Yin Chan, Dr, Princess Margaret Hospital, Hong Kong |
| ClinicalTrials.gov Identifier: | NCT01014000 History of Changes |
| Other Study ID Numbers: | EOPT01 |
| Study First Received: | November 13, 2009 |
| Last Updated: | March 24, 2013 |
| Health Authority: | Hong Kong: Ethics Committee |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 17, 2013