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

Heart Failure, Congestive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00279955
• Other study ID #: 235
• Status: Completed
• Phase: N/A
• First received: January 18, 2006
• Last updated: June 11, 2012
• Start date: June 2004
• Est. completion date: June 2008

Study information

• Verified date: June 2012
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1024
• Est. completion date: June 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Heart Failure (HF) Related Adverse Event (AE)	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	No
Secondary	Occurrence of Heart Failure (HF) Related Healthcare Utilization (HU)	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	No
Secondary	Occurrence of Heart Failure (HF) Related Pulmonary Congestion Event (PCE)	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	No