← Back to Search

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

GUIDE-HF Trial Summary

This trial will show whether the CardioMEMS™ HF System is effective in reducing heart failure events in patients who are at risk for them.

Eligible Conditions

Heart Failure
Congestive Heart Failure

GUIDE-HF Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

(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 outcome measures

Upper arm

(Randomized Arm) All-cause mortality

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

+11 more

Other outcome measures

(Randomized Arm) All-cause hospitalizations

(Randomized Arm) Cardiovascular mortality

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

+15 more

GUIDE-HF 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor

638 Previous Clinical Trials

402,123 Total Patients Enrolled

124 Trials studying Heart Failure

49,624 Patients Enrolled for Heart Failure

Nessa Johnson, PhDStudy DirectorAbbott

Poornima Sood, MD, MBAStudy DirectorAbbott

7 Previous Clinical Trials

2,379 Total Patients Enrolled

6 Trials studying Heart Failure

2,370 Patients Enrolled for Heart Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the underlying purpose of this medical trial?

"This trial's primary endpoint, which will be observed for 12 months after implantation, is a composite of heart failure hospitalizations (HFHs), intravenous diuretic visits and all-cause mortality. Secondary outcomes encompass 6 minute hall walk test distance, the number of HFHs and emergency room/hospital outpatient observation visits for IV diuretics."

Answered by AI

How many research centers are managing this investigation?

"This medical study is being conducted at Waukesha Memorial Hospital in Wisconsin, Akron City Hospital in Ohio, and Southlake Regional Health Centre in Ontario. Additionally, there are other 100 sites involved with this trial around the globe."

Answered by AI

Are there any available vacancies in this research study?

"Verification of the clinicaltrials.gov page reveals that this particular study is not currently in search of volunteers. The trial was initially listed on March 15, 2018 and has not been updated since August 26, 2022. However, there are 709 other trials actively recruiting participants at present."

Answered by AI