Hemodynamic-GUIDEd Management of Heart Failure (GUIDE-HF Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Abbott Medical Devices

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests a heart monitoring device called the CardioMEMS™ HF System in patients with severe heart failure symptoms or a history of hospitalizations. The device helps doctors track heart pressure and manage treatment to prevent future heart issues. CardioMEMS is a wireless pulmonary artery pressure monitoring device that has shown efficacy in reducing heart failure hospitalizations.

Eligibility Criteria

Treatment Details

3Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System.

Group II: Randomized Arm - Treatment GroupExperimental Treatment1 Intervention

Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System.

Group III: Randomized Arm - Control GroupExperimental Treatment1 Intervention

Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System.