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Completed

NCT Number: NCT00279955

PARTNERS HF: 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.

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Key information

Conditions

Heart Failure, Congestive Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Huntsville, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cardiac Resynchronization Therapy Device

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Collaborators

  • Medtronic

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Jan 20, 2006
Registry last updated
Jun 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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