Detect Fluid Early From Intra-thoracic Impedance Monitoring
(DEFEAT-PE Trial)
Recruiting at33 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Abbott Medical Devices
No Placebo Group
Trial Summary
What is the purpose of this trial?
To demonstrate the safety and effectiveness of the Impedance Monitoring Feature in St Jude Medical cardiac devices.
Research Team
EK
Edwin K Heist, MD, PhD
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
Must have a St. Jude Medical (SJM) ICD or CRT-D for at least 31 days
Must have had an episode of acute decompensated heart failure (ADHF) within the past 6 months
Treatment Details
Interventions
- Impedance Monitoring Feature (Device)
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Implantable Cardioverter Defibrillator (ICD)Experimental Treatment1 Intervention
Impedance Monitoring Feature in an Implantable Cardioverter Defibrillator (ICD).
Group II: Cardiac Resynchronization Therapy (CRT-D)Experimental Treatment1 Intervention
Impedance Monitoring Feature in a Cardiac Resynchronization Therapy (CRT-D) device.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Abbott Medical Devices
Lead Sponsor
Trials
659
Recruited
420,000+
Founded
1888
Headquarters
Abbott Park, Illinois, USA
Known For
Medical Devices Innovation
Top Products
FreeStyle Libre, MitraClip, XIENCE Stents, TECNIS IOLs
Dr. Etahn Korngold
Abbott Medical Devices
Chief Medical Officer
Medical training at Harvard Medical School and Massachusetts General Hospital
Robert B. Ford
Abbott Medical Devices
Chief Executive Officer since 2020
Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business