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Device

CardioMems for Mitral Valve Regurgitation (CardioClip Trial)

Q: Are there any available positions for patients to participate in this clinical trial?

According to the details on clinicaltrials.gov, patient recruitment for this study is no longer ongoing. The trial was first listed on February 1st, 2024 and its last update was on January 27th, 2024. Nonetheless, it's worth noting that there are currently 839 other trials actively seeking participants.

Q: What criteria must individuals meet to participate in this medical study?

Participants aged between 18 and 90 with a diagnosis of mitral valve regurgitation are eligible for this trial, which aims to enroll approximately 60 individuals.

Q: Are individuals above the age of 50 eligible to participate in this study?

Participants eligible for enrollment in this research study must fall within the age range of 18 to 90. It is worth noting that there are a total of 25 studies dedicated to individuals below 18 years old and 827 involving patients over the age of 65.

N/A

Waitlist Available

Led By Nir Uriel, 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

CardioClip Trial 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.Check my eligibility

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.See study design

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.

CardioClip Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My heart's pumping ability is reduced but not severely impaired.

Select...

I experience mild to severe heart symptoms.

CardioClip Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

All cause-mortality or heart failure hospitalization (HFH)

Secondary outcome measures

6-minute walk test (6MWT) at 12 months

All-cause mortality rate at 12 months

All-cause mortality rate at 24 months

+19 more

CardioClip 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,432 Previous Clinical Trials

2,460,913 Total Patients Enrolled

AbbottIndustry Sponsor

750 Previous Clinical Trials

478,240 Total Patients Enrolled

Nir Uriel, MDPrincipal InvestigatorColumbia University

3 Previous Clinical Trials

370 Total Patients Enrolled

Frequently Asked Questions

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

Are there any available positions for patients to participate in this clinical trial?

"According to the details on clinicaltrials.gov, patient recruitment for this study is no longer ongoing. The trial was first listed on February 1st, 2024 and its last update was on January 27th, 2024. Nonetheless, it's worth noting that there are currently 839 other trials actively seeking participants."

Answered by AI

What criteria must individuals meet to participate in this medical study?

"Participants aged between 18 and 90 with a diagnosis of mitral valve regurgitation are eligible for this trial, which aims to enroll approximately 60 individuals."

Answered by AI

Are individuals above the age of 50 eligible to participate in this study?

"Participants eligible for enrollment in this research study must fall within the age range of 18 to 90. It is worth noting that there are a total of 25 studies dedicated to individuals below 18 years old and 827 involving patients over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The CardioClip Study

Nir Uriel 2024. "The CardioClip Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06241430.