Optivol Diagnostic Data for Discharge in Heart Failure

(3DHF Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by David J Whellan, MD MHS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Thomas Jefferson University

No Placebo Group

Trial Summary

What is the purpose of this trial?

The objective of this study is to evaluate whether the heart rate variability, daily heart rate, and/or intrathoracic impedance recorded by implantable cardiac devices can be used in conjunction with other traditional clinical practice methods to determine if heart failure patients are ready for hospital discharge.

Research Team

David J Whellan, MD MHS

Principal Investigator

Thomas Jefferson University

Eligibility Criteria

Inclusion Criteria

Patients implanted with a Medtronic InSync Sentry or subsequent FDA-approved Medtronic device with the OptiVol capability for >30 days.

Anticipated hospitalization stay >48 hours

Hospitalized patients experiencing worsening heart failure with symptoms of lung/pulmonary congestion.

Treatment Details

Interventions

• Implantable Cardiac Devices (Diagnostic Device)

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Dr. Eugene Kennedy

Thomas Jefferson University

Chief Medical Officer since 2020

MD

Dr. Joseph G. Cacchione

Thomas Jefferson University

Chief Executive Officer since 2022

MD, MBA

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc