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

Condition(s) targeted: Heart Failure, Congestive

Intervention: Cardiac Resynchronization Therapy Device (Device)

Phase: N/A

Status: Completed

Sponsored by: Medtronic Cardiac Rhythm Disease Management

Official(s) and/or principal investigator(s):
David Whellan, MD, Principal Investigator, Affiliation: Jefferson Heart Institute

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.

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Occurrence of Heart Failure (HF) Related Adverse Event (AE)

Secondary outcome:

Occurrence of Heart Failure (HF) Related Healthcare Utilization (HU)

Occurrence of Heart Failure (HF) Related Pulmonary Congestion Event (PCE)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Huntsville, Alabama, United States

Phoenix, Arizona, United States

Scottsdale, Arizona, United States

Little Rock, Arkansas, United States

Loma Linda, California, United States

San Diego, California, United States

Denver, Colorado, United States

Guilford, Connecticut, United States

Bradenton, Florida, United States

Ft. Lauderdale, Florida, United States

Key Largo, Florida, United States

Melbourne, Florida, United States

Miami, Florida, United States

Orlando, Florida, United States

Palm Beach Gardens, Florida, United States

Pensacola, Florida, United States

Safety Harbor, Florida, United States

Tallahassee, Florida, United States

Tampa, Florida, United States

Winter Park, Florida, United States

Atlanta, Georgia, United States

Augusta, Georgia, United States

Honolulu, Hawaii, United States

Evanston, Illinois, United States

Maywood, Illinois, United States

Merrionette Park, Illinois, United States

Rockford, Illinois, United States

Springfield, Illinois, United States

Winfield, Illinois, United States

Topeka, Kansas, United States

Wichita, Kansas, United States

Edgewood, Kentucky, United States

Florence, Kentucky, United States

Louisville, Kentucky, United States

Covington, Louisiana, United States

Monroe, Louisiana, United States

Portland, Maine, United States

Salisbury, Maryland, United States

Takoma Park, Maryland, United States

Grand Rapids, Michigan, United States

Marquette, Michigan, United States

Petoskey, Michigan, United States

Traverse City, Michigan, United States

Minneapolis, Minnesota, United States

St. Cloud, Minnesota, United States

St. Louis, Missouri, United States

Missoula, Montana, United States

Las Vegas, Nevada, United States

Manchester, New Hampshire, United States

Cherryhill, New Jersey, United States

Ridgewood, New Jersey, United States

Sewell, New Jersey, United States

Bronx, New York, United States

New York, New York, United States

West Islip, New York, United States

Williamsville, New York, United States

Charlotte, North Carolina, United States

Durham, North Carolina, United States

Greensboro, North Carolina, United States

Raleigh, North Carolina, United States

Bismarck, North Dakota, United States

Fargo, North Dakota, United States

Cincinnati, Ohio, United States

Columbus, Ohio, United States

Dayton, Ohio, United States

Elyria, Ohio, United States

Lakewood, Ohio, United States

Mayfield Heights, Ohio, United States

West Lake, Ohio, United States

Medford, Oregon, United States

Camp Hill, Pennsylvania, United States

Erie, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Wormleysburg, Pennsylvania, United States

York, Pennsylvania, United States

Pawtucket, Rhode Island, United States

Providence, Rhode Island, United States

Columbia, South Carolina, United States

Spartanburg, South Carolina, United States

Sioux Falls, South Dakota, United States

Knoxville, Tennessee, United States

Nashville, Tennessee, United States

Fairfax, Texas, United States

Fort Worth, Texas, United States

Lubbock, Texas, United States

Burlington, Vermont, United States

Lynchburg, Virginia, United States

Norfolk, Virginia, United States

Richmond, Virginia, United States

Kirkland, Washington, United States

Green Bay, Wisconsin, United States

Madison, Wisconsin, United States

Starting date: June 2004
Last updated: June 11, 2012