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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Failure Cardiac Resynchronization Therapy Echocardiography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Empirical

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

Group Type ACTIVE_COMPARATOR

Empirical group

Intervention Type DEVICE

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

Echocardiography-guided approach

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

Group Type EXPERIMENTAL

Echocardiography-guided approach

Intervention Type DEVICE

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

Interventions

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Empirical group

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

Intervention Type DEVICE

Echocardiography-guided approach

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No