Risk Stratification and Benefits With Cardiac Resynchronization Therapy (CRT)

NCT00996086 | Completed DMC

• 1 other identifier: CRD 480
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 2

Brief Summary

This is an observational study to learn which patients benefit from CRT therapy and to track the clinical changes that help identify the risk-level of CRT patients.

Conditions

Heart Failure; Ventricular Arrhythmias

Outcome Measures

Primary Outcomes (3)

• Change in 6-minute hall walk distance between baseline and subsequent follow-up

  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)

  12 months

• The occurrence of either death (all-cause) or first HF hospitalization.

  12 months

Secondary Outcomes (3)

• Quality of Life

  12 months

• Change in echocardiographic variables including: a. Ejection Fraction b. Wall motion score c. Increase in TD velocity d. Yu index

  12 months

• Cause-specific mortality

  12 months

Study Arms (1)

CRT device-recipients

Device: CRT device implant

Interventions

CRT device implant DEVICE

CRT device-recipients

CRT device-recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who undergo implantation of a market-approved St. Jude Medical CRT defibrillator (CRT-D) and a compatible lead system may be included in the study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead
• Northwestern University: collaborator
• VA Pittsburgh Healthcare System: collaborator

Study Sites (2)

Touro College

New York, New York, 10010, United States

Location

Veterans' Adminstration Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15240, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

There is a genetic substudy that will evaluate the presence of certain protein markers.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Alan Kadish, M.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Alaa Shalaby, M.D.

  VA Pittsburgh Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2009
• First Posted: October 16, 2009
• Study Start: February 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

US (2)