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

OPTimization of Left-Ventricular Lead Implantation by Echocardiography- E-OPT Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Heart Failure; Cardiac Resynchronization Therapy; Echocardiography
• Intervention / Treatment: Device: Empirical group; Device: Echocardiography-guided approach

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong, China, 852
    • Princess Margaret Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical response (Improvement in functional class status by at least one NYHA Class or ≥10% increase in 6-minute hall walk distance) to CRT	6 months after device implantation

Secondary Outcome Measures

Outcome Measure	Time Frame
Echocardiographic response of ≥15% reduction in LVESV	6 months after device implantation
Echocardiographic response of absolute increase of ≥5% in LVEF	6 months after device implantation
Biochemical response with reduction of BNP level≥15%	6 months after device implantation

Collaborators and Investigators

• Sponsor: Princess Margaret Hospital, Hong Kong
• Collaborators: Medtronic
• Investigators: Principal Investigator: Ngai Yin Chan, MBBS, Princess Margaret Hospital, Canada

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: November 13, 2009
• First Submitted That Met QC Criteria: November 13, 2009
• First Posted (Estimate): November 16, 2009

Study Record Updates

• Last Update Posted (Estimate): September 4, 2015
• Last Update Submitted That Met QC Criteria: September 3, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: EOPT01