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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01014000

Acronym

E-OPT

Enrollment

Registered

2009-11-16

Start date

2015-06-30

Completion date

2015-06-30

Last updated

2015-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Resynchronization Therapy, Echocardiography, Heart Failure

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.

Interventions

DEVICEEmpirical group

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

DEVICEEchocardiography-guided approach

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

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

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026