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. (see Contacts and Locations)
Verified March 2013 by Princess Margaret Hospital, Hong Kong
Sponsor:
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
  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

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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 23, 2014