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

June 11, 2012 updated by: Medtronic Cardiac Rhythm and Heart Failure

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

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.

Study Overview

Status

Completed

Conditions

Heart Failure, Congestive

Intervention / Treatment

Device: Cardiac Resynchronization Therapy Device

Study Type

Observational

Enrollment (Actual)

1024

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alabama
  - Huntsville, Alabama, United States
- Arizona
  - Phoenix, Arizona, United States
  - Scottsdale, Arizona, United States
- Arkansas
  - Little Rock, Arkansas, United States
- California
  - Loma Linda, California, United States
  - San Diego, California, United States
- Colorado
  - Denver, Colorado, United States
- Connecticut
  - Guilford, Connecticut, United States
- Florida
  - 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
- Georgia
  - Atlanta, Georgia, United States
  - Augusta, Georgia, United States
- Hawaii
  - Honolulu, Hawaii, United States
- Illinois
  - 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
- Kansas
  - Topeka, Kansas, United States
  - Wichita, Kansas, United States
- Kentucky
  - Edgewood, Kentucky, United States
  - Florence, Kentucky, United States
  - Louisville, Kentucky, United States
- Louisiana
  - Covington, Louisiana, United States
  - Monroe, Louisiana, United States
- Maine
  - Portland, Maine, United States
- Maryland
  - Salisbury, Maryland, United States
  - Takoma Park, Maryland, United States
- Michigan
  - Grand Rapids, Michigan, United States
  - Marquette, Michigan, United States
  - Petoskey, Michigan, United States
  - Traverse City, Michigan, United States
- Minnesota
  - Minneapolis, Minnesota, United States
  - St. Cloud, Minnesota, United States
- Missouri
  - St. Louis, Missouri, United States
- Montana
  - Missoula, Montana, United States
- Nevada
  - Las Vegas, Nevada, United States
- New Hampshire
  - Manchester, New Hampshire, United States
- New Jersey
  - Cherryhill, New Jersey, United States
  - Ridgewood, New Jersey, United States
  - Sewell, New Jersey, United States
- New York
  - Bronx, New York, United States
  - New York, New York, United States
  - West Islip, New York, United States
  - Williamsville, New York, United States
- North Carolina
  - Charlotte, North Carolina, United States
  - Durham, North Carolina, United States
  - Greensboro, North Carolina, United States
  - Raleigh, North Carolina, United States
- North Dakota
  - Bismarck, North Dakota, United States
  - Fargo, North Dakota, United States
- Ohio
  - 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
- Oregon
  - Medford, Oregon, United States
- Pennsylvania
  - 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
- Rhode Island
  - Pawtucket, Rhode Island, United States
  - Providence, Rhode Island, United States
- South Carolina
  - Columbia, South Carolina, United States
  - Spartanburg, South Carolina, United States
- South Dakota
  - Sioux Falls, South Dakota, United States
- Tennessee
  - Knoxville, Tennessee, United States
  - Nashville, Tennessee, United States
- Texas
  - Fairfax, Texas, United States
  - Fort Worth, Texas, United States
  - Lubbock, Texas, United States
- Vermont
  - Burlington, Vermont, United States
- Virginia
  - Lynchburg, Virginia, United States
  - Norfolk, Virginia, United States
  - Richmond, Virginia, United States
- Washington
  - Kirkland, Washington, United States
- Wisconsin
  - Green Bay, Wisconsin, United States
  - Madison, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of Heart Failure (HF) Related Adverse Event (AE) Time Frame: From 6 month to the 12 month visit	Number of participates with HF realted adverse event will be reported. Time to the first HF related Adverse event in the "Follow-up Period" from the 6-month visit to the 12-month visit is compared between two risk groups. The goal was to test if there is a significant difference in time to first HF-related adverse event between two groups. A heart failure related (HF-related) adverse event is defined as an adverse event that results in a subject's worsening HF or related to the heart's inability to meet the metabolic demands of the body.	From 6 month to the 12 month visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of Heart Failure (HF) Related Healthcare Utilization (HU) Time Frame: 6 month to the 12 month visit	Number of participates with HF realted healthcare utilization will be reported. Time to the first HF-related healthcare utilization in the "Follow-up Period" from the 6-month visit to the 12-month visit is compared between two risk groups. The goal was to test if there is a significant difference in time to first HF-related healthcare utilization between two groups. A heart failure related (HF-related) healthcare utilization is defined as unscheduled office visits, hospitalizations, urgent care visits, and emergency room visits which is resulted by heart failure related adverse event.	6 month to the 12 month visit
Occurrence of Heart Failure (HF) Related Pulmonary Congestion Event (PCE) Time Frame: 6 month to the 12 month visit	Number of participates with HF related pulmonary congestion event will be reported. Time to the first HF related pulmonary cogestion event in the "Follow-up Period" from the 6-month visit to the 12-month visit is compared between two risk groups to see if there is significant difference. A HF related pulmonary congestion event is defined as hospitalization with signs and/or symptoms of pulmonary congestion, or outpatient treatment with IV diuretics due to exacerbation of HF with signs and/or symptoms of pulmonary congestion.	6 month to the 12 month visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Collaborators

Medtronic

Investigators

Principal Investigator: David Whellan, MD, Jefferson Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

January 18, 2006

First Submitted That Met QC Criteria