Cardiac Compass With Optivol® to Negate Future Inpatient Re-admissions Through Monitoring in HF Patients (CONFIRM-HF)

Heart Failure Clinical Trial

— CONFIRM-HF  

Official title:

Cardiac Compass With Optivol® to Negate Future Inpatient Re-admissions Through Monitoring in Heart Failure Patients (CONFIRM-HF)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02026635
• Other study ID #: 13P.296
• Status: Withdrawn
• Phase: N/A
• First received: December 16, 2013
• Last updated: February 4, 2015
• Start date: September 2013
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

A research study to determine if heart failure can be medically managed using data collected from cardiac monitoring devices

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years of age

• Admission for worsening of HF

• Discharged to home

• Have appropriate cardiac device with OptiVol® implanted for at least 34 days prior to enrollment

• Enrolled in Carelink® system and able to transmit data

• Able to participate for at least 3 months

Exclusion Criteria:

• Post heart transplant or actively listed

• End-stage (Stage D) HF, including treatment with chronic ionotropic drugs or left ventricular assist device support

• Stage IV or V chronic renal dysfunction (GFR <25 mol/min per 1.73 M2)

• Severe Chronic Obstructive Pulmonary Disease (COPD) requiring home oxygen

• Severe pulmonary hypertension not due to left-sided HF

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physician Use of Cardiac Compass Reports to Determine HF Treatment Decisions	Assessment will be completed at time of enrollment and days 3 to 7, 14 to 21, 30 and 90 post discharge.	90 days from enrollment	No
Secondary	Heart Failure Clinical Events	Track HF re-admissions and other clinical encounters between 30 and 90 days post discharge for HF.	90 days from enrollment	No
Secondary	Assess Patient-Reported Quality of Life	Assess the association between the use of Cardiac Compass Report and OptiVol® and improved HF patient quality of life at both time points (30 and 90 days post discharge) utilizing the Kansas City Cardiomyopathy Questionnaire (KCCQ)	90 days from enrollment	No