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

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00279955
First received: January 18, 2006
Last updated: June 11, 2012
Last verified: June 2012
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Occurrence of Heart Failure (HF) Related Adverse Event (AE) [ Time Frame: From 6 month to the 12 month visit ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Occurrence of Heart Failure (HF) Related Healthcare Utilization (HU) [ Time Frame: 6 month to the 12 month visit ] [ Designated as safety issue: No ]
    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.

  • Occurrence of Heart Failure (HF) Related Pulmonary Congestion Event (PCE) [ Time Frame: 6 month to the 12 month visit ] [ Designated as safety issue: No ]
    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.


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:
    Device: 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.
  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

No publications provided by Medtronic Cardiac Rhythm Disease Management

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT00279955     History of Changes
Other Study ID Numbers: 235
Study First Received: January 18, 2006
Results First Received: July 20, 2011
Last Updated: June 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Heart Failure, Congestive
Implantable Cardioverter-Defibrillators

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013