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

NCT01014000 | Withdrawn

• 1 other identifier: EOPT01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Cardiac Resynchronization Therapy; Echocardiography

Outcome Measures

Primary Outcomes (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

  6 months after device implantation

Secondary Outcomes (3)

• 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

Study Arms (2)

Empirical

ACTIVE COMPARATOR

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

Device: Empirical group

Echocardiography-guided approach

EXPERIMENTAL

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

Device: Echocardiography-guided approach

Interventions

Empirical group DEVICE

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

Empirical

Echocardiography-guided approach DEVICE

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

Echocardiography-guided approach

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Princess Margaret Hospital, Hong Kong: lead
• Medtronic: collaborator

Study Sites (1)

Princess Margaret Hospital

Hong Kong, 852, China

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Ngai Yin Chan, MBBS

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 13, 2009
• First Posted: November 16, 2009
• Study Start: June 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 4, 2015

Record last verified: 2015-09

Locations

CN (1)