PARTNERS HF: Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure

This study has been completed.

Sponsors and Collaborators:	Medtronic Cardiac Rhythm Disease Management Medtronic
Information provided by:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT00279955

Purpose

The purpose of this study is to determine the value of diagnostic data obtained from Medtronic implantable cardioverter defibrillators (ICDs) with cardiac resynchronization therapy (CRT) to evaluate cardiovascular and heart failure related adverse events and health care utilization.

Condition	Intervention
Heart Failure, Congestive	Device: Cardiac Resynchronization Therapy Device

MedlinePlus related topics: Heart Failure Pacemakers and Implantable Defibrillators

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	1024
Study Start Date:	June 2004
Study Completion Date:	June 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Patients with an ICD indication, a CRT indication and symptomatic heart failure who are implanted with a Cardiac Resynchronization Therapy Device.

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

Patients receiving a specified Medtronic Implantable Cardiac Resynchronization Therapy Defibrillator device where informed consent and/or authorization to use and disclose health information permission has been granted.

Criteria

Inclusion Criteria:

Patients who meet the ICD indications
Patients with Class III or IV heart failure.
Patients receiving or who received a Medtronic CRT ICD within the previous 3 months.
Patient must sign and date informed consent, and be 18 years of age or greater.
Patient must be available for follow up visits, and be willing and able to comply with study protocol.

Exclusion Criteria:

Patient with acute myocardial infarction (MI), coronary artery bypass graft surgery (CABG) or percutaneous coronary angioplasty (PTCA)/stent within the last month.
Patient with a mechanical right heart valve.
Patient with chronic (permanent) atrial arrhythmias.
Patient with life expectancy of less than 12 months.
Patient with status post heart transplant
Patient undergoing kidney dialysis
Patients enrolled in a concurrent study that may confound the results of the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00279955

Show 93 Study Locations

Sponsors and Collaborators

Medtronic Cardiac Rhythm Disease Management

Medtronic

Investigators

Principal Investigator:

David Whellan, MD

Jefferson Heart Institute

More Information

Publications indexed to this study:

Whellan DJ, O'Connor CM, Ousdigian KT, Lung TH; PARTNERS HF Study Investigators. Rationale, design, and baseline characteristics of a Program to Assess and Review Trending INformation and Evaluate CorRelation to Symptoms in Patients with Heart Failure (PARTNERS HF). Am Heart J. 2008 Nov;156(5):833-9, 839.e2. Epub 2008 Sep 23.

Responsible Party:	Medtronic CRDM ( CRDM Core Clinical )
Study ID Numbers:	235
Study First Received:	January 18, 2006
Last Updated:	July 14, 2008
ClinicalTrials.gov Identifier:	NCT00279955
Health Authority:	United States: Institutional Review Board

Keywords provided by Medtronic Cardiac Rhythm Disease Management:

Heart Failure, Congestive
Implantable Cardioverter-Defibrillators

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009