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Device

CardioMEMS™ HF System for Heart Failure (GUIDE-HF Trial)

N/A

Waitlist Available

Research Sponsored by Abbott Medical Devices

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6, and 12 months post-implantation

Awards & highlights

No Placebo-Only Group

Summary

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.

Eligible Conditions

Heart Failure
Congestive Heart Failure

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6, and 12 months post-implantation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6, and 12 months post-implantation

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6, and 12 months post-implantation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

(Randomized Arm) Composite outcome of (1) HFHs, (2) intravenous diuretic visits, and (3) all-cause mortality

(Single Arm) Composite outcome of (1) HFHs, (2) intravenous diuretic visits, and (3) all-cause mortality

Secondary study objectives

Upper arm

(Randomized Arm) All-cause mortality

(Randomized Arm) Composite outcome of (1) HFHs and (2) intravenous diuretic visits

+11 more

Other study objectives

(Randomized Arm) All-cause hospitalizations

(Randomized Arm) Cardiovascular mortality

(Randomized Arm) Frequency of clinician review of subject PA pressure uploads

+15 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CardioMEMS™ HF System

2018

N/A

~2360

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