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Device

CardioMEMS for Heart Failure (CardioClip Trial)

N/A
Recruiting
Led By Michael Brener, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Left ventricular dysfunction (ejection fraction >20% and <50%)
New York Heart Association (NYHA) class II-IVa symptoms
Must not have
Complex congenital heart disease
Recurrent (i.e., >1) pulmonary embolism or deep vein thrombosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month, 6 months, 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a wireless sensor inserted through a vein in the groin to monitor pressure in the pulmonary artery. The goal is to see if the sensor can provide real-time information about heart function to help

Who is the study for?
The CardioClip study is for individuals with heart failure and mitral valve regurgitation. Participants should be suitable for the non-surgical insertion of a wireless sensor through a vein in the groin, similar to mTEER procedure.
What is being tested?
This trial tests a wireless sensor called CardioMEMS that monitors pulmonary artery pressure. It's inserted via the groin and sends heart function data so doctors can adjust treatments promptly based on real-time information.
What are the potential side effects?
Potential side effects may include discomfort or bruising at the insertion site, risk of infection, possible allergic reaction to materials in the device, and rare complications related to catheter use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart's pumping ability is reduced but not severely impaired.
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I experience mild to severe heart symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I was born with a complex heart condition.
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I have had more than one blood clot in my lungs or deep veins.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month, 6 months, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary (OS) score between baseline (pre-mTEER) and 12 months after mTEER.
Secondary study objectives
6-minute walk test (6MWT) at 12 months
All-cause mortality rate at 12 months
Change in 6-minute walk test (6MWT) from baseline to 12 months
+17 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CardioMemsExperimental Treatment1 Intervention
Participants randomized to this arm will receive hemodynamic-guided GDMT titration with CardioMems.
Group II: Usual CareActive Control1 Intervention
Participants randomized to this arm will receive usual care involving GDMT.

Find a Location

Who is running the clinical trial?

AbbottIndustry Sponsor
753 Previous Clinical Trials
479,175 Total Patients Enrolled
20 Trials studying Heart Failure
6,003 Patients Enrolled for Heart Failure
Columbia UniversityLead Sponsor
1,486 Previous Clinical Trials
2,663,130 Total Patients Enrolled
21 Trials studying Heart Failure
6,258 Patients Enrolled for Heart Failure
Michael Brener, MDPrincipal InvestigatorColumbia University
~40 spots leftby Nov 2026
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