What side effects are associated with this type of intervention?

Common side effects of treatments for tricuspid regurgitation, particularly those involving transcatheter and surgical interventions like the Cardiac Implants (CI) annuloplasty ring, include bleeding, infection, arrhythmias, and damage to the heart or surrounding structures. There are also risks related to the implantation process, such as device migration or malfunction, and the potential need for re-intervention.

What prior FDA approvals exist?

As of now, there are limited FDA-approved treatments specifically targeting tricuspid regurgitation through annuloplasty devices similar to the Cardiac Implants (CI) annuloplasty ring. Most treatments for tricuspid regurgitation have focused on surgical repair or replacement of the valve. However, advancements in transcatheter techniques, such as the use of annuloplasty rings and other devices designed to reshape and stabilize the tricuspid valve annulus, are currently under investigation in clinical trials. These emerging therapies aim to provide less invasive options compared to traditional open-heart surgery.

What other types of research exist?

Promising novel alternatives to the Cardiac Implants (CI) annuloplasty ring for tricuspid regurgitation include transcatheter tricuspid valve repair (TTVR) devices such as the TriClip, which clips the leaflets of the tricuspid valve to reduce regurgitation, and the PASCAL system, which uses a similar clipping mechanism. Additionally, transcatheter tricuspid valve replacement (TTVR) options like the EVOQUE tricuspid valve replacement system are emerging as potential treatments. These minimally invasive approaches are gaining traction due to their reduced recovery times and promising early results.

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Annuloplasty Ring

Percutaneous Ring Annuloplasty for Tricuspid Regurgitation

N/A

Recruiting

Research Sponsored by Cardiac Implants LLC

Eligibility Criteria Checklist

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

Must have

New York Heart Associate Classification ≥ II.

Moderate to severe functional tricuspid regurgitation (TR) defined by ASE guidelines and the European Association of Echocardiography guidelines.

Must not have

Aortic, mitral and/or pulmonic valve stenosis and/or regurgitation more than moderate.

Cerebro-Vascular Accident within the previous 3 months.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post-adjustment

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a device called the CI annuloplasty ring, which helps a faulty heart valve close properly. It targets patients with moderate or worse tricuspid regurgitation. The ring is inserted through a vein in the neck and can be adjusted later to ensure it fits well and reduces the valve opening size.

Who is the study for?

Adults over 18 with moderate to severe functional tricuspid regurgitation, a heart condition where the valve doesn't close tightly. They must have a left ventricular ejection fraction of at least 30%, suitable anatomy for the device, and be able to follow study procedures. Excluded are those with recent heart failure hospitalization, severe right ventricle issues, high lung artery pressure, or other conditions that could interfere with the trial.

What is being tested?

The trial is testing a new Cardiac Implants Percutaneous Ring Annuloplasty System designed for people suffering from significant tricuspid valve leakage. It involves placing an annuloplasty ring via catheter and adjusting it after about three months to see if it improves heart function.

What are the potential side effects?

Potential side effects may include complications related to catheter insertion such as bleeding or infection, adverse reactions to materials in the device like stainless steel or nitinol, and possible interference with existing pacemaker or defibrillator leads.

Eligibility Criteria

Inclusion Criteria

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

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My heart condition limits my physical activity.

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My heart valve issue is moderate to severe, as per specific guidelines.

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I am 18 years old or older.

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I still have symptoms of heart failure despite taking all my medications.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have moderate to severe heart valve issues.

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I have not had a stroke in the last 3 months.

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I have acute anemia.

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My heart's tricuspid valve can't be seen clearly for the procedure.

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I cannot undergo heart imaging tests through my chest or esophagus.

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I am not on IV drugs to support my heart function.

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I have been taking oral steroids for 6 months or more.

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I cannot take blood thinners or certain heart medications.

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My heart valve issue is due to a natural cause like infection or a birth defect.

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I am currently being treated for a clot or mass in my heart.

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I have a narrowed tricuspid valve in my heart.

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I am not pregnant or breastfeeding.

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I cannot or will not receive blood transfusions.

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I have had surgery on my tricuspid valve before.

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I have severe kidney problems or am on dialysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post-adjustment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year post-adjustment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-adjustment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Freedom from device or procedure-related mortality

Secondary study objectives

Functional: Changes in Distance Walked for Exercise Tolerance

Functional: Changes in NYHA Classification

Functional: Changes in Quality of Life Scores and Sub-Domains

+20 more

Other study objectives

Changes in Heart Failure Biomarkers

Freedom from Heart Failure Events

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: CI Percutaneous Ring Annuloplasty SystemExperimental Treatment1 Intervention

Patients treated with the CI Percutaneous Ring Annuloplasty System

0 / 19Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Tricuspid Regurgitation (TR) include medical management, surgical repair, and transcatheter interventions like the Cardiac Implants (CI) annuloplasty ring. Medical management typically involves diuretics to reduce fluid overload and medications to manage underlying conditions like heart failure. Surgical repair often includes techniques like annuloplasty, where a ring is used to reshape and stabilize the tricuspid valve annulus, thereby reducing regurgitation. The CI annuloplasty ring, specifically, is a transcatheter device that reshapes and stabilizes the tricuspid valve annulus, reducing regurgitation by ensuring better leaflet coaptation. This is crucial for TR patients as it directly addresses the structural issues causing the regurgitation, potentially improving symptoms and reducing the risk of heart failure.