Risk Stratification and Benefits With Cardiac Resynchronization Therapy (CRT) - Full Text View

Risk Stratification and Benefits With Cardiac Resynchronization Therapy (CRT) (BENEFIT)

This study is currently recruiting participants.

Verified April 2011 by St. Jude Medical

First Received on October 14, 2009. Last Updated on April 4, 2011 History of Changes

Sponsor:	St. Jude Medical
Collaborators:	Northwestern University VA Pittsburgh Healthcare System
Information provided by:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00996086

Purpose

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.

Condition	Intervention
Heart Failure Ventricular Arrhythmias	Device: CRT device implant

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Risk Stratification and Benefits With Cardiac Resynchronization Therapy

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Arrhythmia Heart Failure

U.S. FDA Resources

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:

Change in 6-minute hall walk distance between baseline and subsequent follow-up [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
The occurrence of either death (all-cause) or first HF hospitalization. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of Life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change in echocardiographic variables including: a. Ejection Fraction b. Wall motion score c. Increase in TD velocity d. Yu index [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Cause-specific mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

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

Estimated Enrollment:	150
Study Start Date:	February 2010
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
CRT device-recipients	Device: CRT device implant CRT device-recipients

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00996086

Contacts

Contact: Jasmina Halilovic	408-522-6105	jhalilovic@sjm.com
Contact: Manish S Gupta	818 493 2608	mgupta@sjm.com

Locations

United States, Illinois
Northwestern University	Recruiting
Chicago, Illinois, United States, 60611
Contact: Alan Kadish, M.D.
Contact: Karen Fachet, MS, RN 312.695.1914
United States, Pennsylvania
Veterans' Adminstration Pittsburgh Healthcare System	Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Aala Shalaby, MD FACC 412-688-6176 Alaa.Shalaby@va.gov

Sponsors and Collaborators

St. Jude Medical

Northwestern University

VA Pittsburgh Healthcare System

Investigators

Principal Investigator:	Alan Kadish, M.D.	Northwestern University
Principal Investigator:	Alaa Shalaby, M.D.	VA Pittsburgh Healthcare System

More Information

No publications provided

Responsible Party:	Director, Clinical Studies, St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00996086 History of Changes
Other Study ID Numbers:	CRD 480
Study First Received:	October 14, 2009
Last Updated:	April 4, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Arrhythmias, Cardiac
Heart Failure
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012