Risk Stratification and Benefits With Cardiac Resynchronization Therapy (CRT)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00996086
• Date of registration: 14/10/2009
• Primary sponsor: St. Jude Medical
• Public title: Risk Stratification and Benefits With Cardiac Resynchronization Therapy (CRT) BENEFIT
• Scientific title: Risk Stratification and Benefits With Cardiac Resynchronization Therapy
• Date of first enrolment: February 2010
• Target sample size: 150
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00996086
• Study type: Observational
• Study design: Observational Model: Case-Only, Time Perspective: Prospective

Countries of recruitment

United States

Contacts

• Name: Jasmina Halilovic

• Name: Alan Kadish, M.D.
• Affiliation: Northwestern University

• Name: Alaa Shalaby, M.D.
• Affiliation: VA Pittsburgh Healthcare System

Key inclusion & exclusion criteria

Inclusion Criteria:

- Meets current clinical indications for CRT-D therapy

- Patient is 18 years old or older

- Ability to independently comprehend and complete all QOL questionnaires

- Patient has the ability to perform the 6-minute Hall Walk Test (6-MHW) with the only
limiting factor being fatigue or shortness-of-breath

- Ability to provide informed consent for a study and be willing and able to comply
with the prescribed follow-up

Exclusion Criteria:

- Inability to successfully implant an intravascular lead and CRT-D device. (i.e.
exclude epicardial leads) within 30 days of initial procedure.

- Myocardial infarction in the last 3 weeks

- Unstable angina in the last 3 weeks

- Status 1 classification for cardiac transplantation

- Currently participating in a clinical trial that includes an active treatment arm

- Life expectancy of less than 12 months.

- Recent (within 1 week) administration of Nesiritide™ or inotropes

- Patients in whom revascularization is expected

- Patient is pregnant



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Heart Failure

Ventricular Arrhythmias

Intervention(s)

Device: CRT device implant

Primary Outcome(s)

Change in 6-minute hall walk distance between baseline and subsequent follow-up [Time Frame: 12 months]

Composite endpoint a. 6-minute hall walk distance b. NYHA Classification c. Quality of Life (Minnesota Living with Heart Failure, DASS, SF-36) [Time Frame: 12 months]

The occurrence of either death (all-cause) or first HF hospitalization. [Time Frame: 12 months]

Secondary Outcome(s)

Cause-specific mortality [Time Frame: 12 months]

Change in echocardiographic variables including: a. Ejection Fraction b. Wall motion score c. Increase in TD velocity d. Yu index [Time Frame: 12 months]

Quality of Life [Time Frame: 12 months]

Secondary ID(s)

CRD 480

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Northwestern University

VA Pittsburgh Healthcare System