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Comparative Study to Examine Whether Echocardiography Performed During Cardiac Resynchronization Therapy Device Implantation Can Improve the Response Rate (E-OPT)

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ClinicalTrials.gov Identifier: NCT01014000
Recruitment Status : Withdrawn (On reviewing of new data)
First Posted : November 16, 2009
Last Update Posted : September 4, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Heart Failure Cardiac Resynchronization Therapy Echocardiography Device: Empirical group Device: Echocardiography-guided approach

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: OPTimization of Left-Ventricular Lead Implantation by Echocardiography- E-OPT Study
Study Start Date : June 2015
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Echocardiographic response of ≥15% reduction in LVESV [ Time Frame: 6 months after device implantation ]
  2. Echocardiographic response of absolute increase of ≥5% in LVEF [ Time Frame: 6 months after device implantation ]
  3. Biochemical response with reduction of BNP level≥15% [ Time Frame: 6 months after device implantation ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01014000


Locations
China
Princess Margaret Hospital
Hong Kong, China, 852
Sponsors and Collaborators
Princess Margaret Hospital, Hong Kong
Medtronic
Investigators
Principal Investigator: Ngai Yin Chan, MBBS Princess Margaret Hospital, Canada
More Information

Responsible Party: Ngai Yin Chan, Dr, Princess Margaret Hospital, Hong Kong
ClinicalTrials.gov Identifier: NCT01014000     History of Changes
Other Study ID Numbers: EOPT01
First Posted: November 16, 2009    Key Record Dates
Last Update Posted: September 4, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases