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

Primary Purpose

Heart Failure, Cardiac Resynchronization Therapy, Echocardiography

Status
Withdrawn
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Empirical group
Echocardiography-guided approach
Sponsored by
Princess Margaret Hospital, Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Princess Margaret Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Empirical

Echocardiography-guided approach

Arm Description

Empirical implantation of the left ventricular lead during cardiac resynchronization therapy device implantation

Echocardiography-guided implantation of the left ventricular lead during cardiac resynchronization therapy device implantation

Outcomes

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

Secondary Outcome Measures

Echocardiographic response of ≥15% reduction in LVESV
Echocardiographic response of absolute increase of ≥5% in LVEF
Biochemical response with reduction of BNP level≥15%

Full Information

First Posted
November 13, 2009
Last Updated
September 3, 2015
Sponsor
Princess Margaret Hospital, Hong Kong
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT01014000
Brief Title
Comparative Study to Examine Whether Echocardiography Performed During Cardiac Resynchronization Therapy Device Implantation Can Improve the Response Rate
Acronym
E-OPT
Official Title
OPTimization of Left-Ventricular Lead Implantation by Echocardiography- E-OPT Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Withdrawn
Why Stopped
On reviewing of new data
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Princess Margaret Hospital, Hong Kong
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Cardiac Resynchronization Therapy, Echocardiography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Empirical
Arm Type
Active Comparator
Arm Description
Empirical implantation of the left ventricular lead during cardiac resynchronization therapy device implantation
Arm Title
Echocardiography-guided approach
Arm Type
Experimental
Arm Description
Echocardiography-guided implantation of the left ventricular lead during cardiac resynchronization therapy device implantation
Intervention Type
Device
Intervention Name(s)
Empirical group
Intervention Description
Empirical implantation of the left ventricular lead during cardiac resynchronization therapy device implantation
Intervention Type
Device
Intervention Name(s)
Echocardiography-guided approach
Intervention Description
Echocardiography-guided implantation of the left ventricular lead during cardiac resynchronization therapy device implantation
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Echocardiographic response of ≥15% reduction in LVESV
Time Frame
6 months after device implantation
Title
Echocardiographic response of absolute increase of ≥5% in LVEF
Time Frame
6 months after device implantation
Title
Biochemical response with reduction of BNP level≥15%
Time Frame
6 months after device implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ngai Yin Chan, MBBS
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Hong Kong
ZIP/Postal Code
852
Country
China

12. IPD Sharing Statement

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

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