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

Medtronic

Status: Completed

Conditions: Heart Failure, Congestive

Treatments: Device: Cardiac Resynchronization Therapy Device

Study type: Observational

Funder types: Industry

Identifiers

NCT00279955

235

Details and patient eligibility

About

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.

Enrollment: 1,024 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.