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

NCT ID: NCT00279955

Last Updated: 2012-06-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1024 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-06-30

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure, Congestive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Cardiac Resynchronization Therapy Device

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Whellan, MD

Role: PRINCIPAL_INVESTIGATOR

Jefferson Heart Institute

Locations

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Huntsville, Alabama, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Little Rock, Arkansas, United States

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Loma Linda, California, United States

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San Diego, California, United States

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Denver, Colorado, United States

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Guilford, Connecticut, United States

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Bradenton, Florida, United States

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Fort Lauderdale, Florida, United States

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Key Largo, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Palm Beach Gardens, Florida, United States

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Pensacola, Florida, United States

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Safety Harbor, Florida, United States

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Tallahassee, Florida, United States

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Tampa, Florida, United States

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Winter Park, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Honolulu, Hawaii, United States

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Evanston, Illinois, United States

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Maywood, Illinois, United States

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Merrionette Park, Illinois, United States

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Rockford, Illinois, United States

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Springfield, Illinois, United States

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Winfield, Illinois, United States

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Topeka, Kansas, United States

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Wichita, Kansas, United States

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Edgewood, Kentucky, United States

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Florence, Kentucky, United States

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Louisville, Kentucky, United States

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Covington, Louisiana, United States

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Monroe, Louisiana, United States

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Portland, Maine, United States

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Salisbury, Maryland, United States

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Takoma Park, Maryland, United States

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Grand Rapids, Michigan, United States

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Marquette, Michigan, United States

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Petoskey, Michigan, United States

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Traverse City, Michigan, United States

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Minneapolis, Minnesota, United States

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Saint Cloud, Minnesota, United States

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St Louis, Missouri, United States

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Missoula, Montana, United States

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Las Vegas, Nevada, United States

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Manchester, New Hampshire, United States

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Cherryhill, New Jersey, United States

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Ridgewood, New Jersey, United States

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Sewell, New Jersey, United States

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New York, New York, United States

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The Bronx, New York, United States

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West Islip, New York, United States

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Williamsville, New York, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Greensboro, North Carolina, United States

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Raleigh, North Carolina, United States

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Bismarck, North Dakota, United States

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Fargo, North Dakota, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Elyria, Ohio, United States

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Lakewood, Ohio, United States

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Mayfield Heights, Ohio, United States

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Westlake, Ohio, United States

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Medford, Oregon, United States

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Camp Hill, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Wormleysburg, Pennsylvania, United States

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York, Pennsylvania, United States

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Pawtucket, Rhode Island, United States

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Providence, Rhode Island, United States

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Columbia, South Carolina, United States

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Spartanburg, South Carolina, United States

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Sioux Falls, South Dakota, United States

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Knoxville, Tennessee, United States

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Nashville, Tennessee, United States

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Fairfax, Texas, United States

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Fort Worth, Texas, United States

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Lubbock, Texas, United States

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Burlington, Vermont, United States

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Lynchburg, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Kirkland, Washington, United States

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Green Bay, Wisconsin, United States

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Madison, Wisconsin, United States

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Countries

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United States

References

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Whellan DJ, Ousdigian KT, Al-Khatib SM, Pu W, Sarkar S, Porter CB, Pavri BB, O'Connor CM; PARTNERS Study Investigators. Combined heart failure device diagnostics identify patients at higher risk of subsequent heart failure hospitalizations: results from PARTNERS HF (Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure) study. J Am Coll Cardiol. 2010 Apr 27;55(17):1803-10. doi: 10.1016/j.jacc.2009.11.089.

Reference Type DERIVED
PMID: 20413029 (View on PubMed)

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. doi: 10.1016/j.ahj.2008.06.036. Epub 2008 Sep 23.

Reference Type DERIVED
PMID: 19061695 (View on PubMed)

Other Identifiers

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235

Identifier Type: -

Identifier Source: org_study_id

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