Heart Failure and Risk of Re-Admissions Determined by Abnormal REVEAL Parameters

NCT ID: NCT01357408

Last Updated: 2013-01-07

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-05-31

Brief Summary

The purpose of the Heart Failure and Risk of re-Admissions Determined by Abnormal REVEAL Parameters (HF RADAR) study is to evaluate the ability of cardiac rhythm (Cardiac Compass) data to predict future cardiac events in heart failure (HF) patients recently discharged after a hospitalization for heart failure who have or plan to have a implanted loop recorder (ILR), specifically, the Reveal XT device. The study will enroll 40 HF patients (with LV function ≥ 40%) admitted to an acute care facility (observation status or hospital stay) for heart failure who either have a Reveal XT device in place or plan to have the ILR device inserted for clinical indication within 14 days of discharge from the hospitalization. HF patients will be followed for 6 months. Device date will be captured during normal clinic visits and at 6 months.

Conditions

Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

REVEAL XT device

Subjects implanted at time of admission for HF or to be implanted within 14 days of discharge from HF hospitalization for clinical indications\>

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Men and non-pregnant/non lactating women ≥ 18 years.

2. Admission to hospital or observation unit for worsening heart failure.

3. Has a Reveal XT device or has plans for a device implant for a clinical indication within 14 days of discharge.

4. Ejection fraction ≥40% by echocardiogram within 6 months of enrollment

5. Able to participate in the study for at least 6 months.

6. Not currently enrolled in another study.

7. Able to provide informed consent and complete scheduled study visits.

Exclusion Criteria

1. Has a clinical indication for a therapeutic cardiac device (pacemaker or defibrillator)

2. History of permanent atrial fibrillation or atrial flutter.

3. History of uncontrolled hypertension (high blood pressure)

4. Has a previously implanted cardiac device (pacemaker or defibrillator) in place.

5. Stage IV or V chronic renal dysfunction (estimated GFR <25 ml/min per 1.73 m2)

6. End-stage (Stage D) HF, including chronic ionotropic drugs infusions or left ventricular assist device

7. Waiting on the transplant list as an UNOS status 1A or 1B patient

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Bucks Specialists, Ltd.

OTHER

Sponsor Role: collaborator

Drexel University

OTHER

Sponsor Role: collaborator

The Valley Hospital

UNKNOWN

Sponsor Role: collaborator

Saint Thomas Research Institute, LLC

OTHER

Sponsor Role: collaborator

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

080-18014-J66601

Identifier Type: -

Identifier Source: org_study_id