Percutaneous Ring Annuloplasty for Tricuspid Regurgitation

Recruiting at 1 trial location

Overseen By Noa Avisar, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cardiac Implants LLC

Must not be taking: Anticoagulants, Antiplatelets, Steroids, others

Disqualifiers: Heart failure, Valve stenosis, Renal impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 32

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new heart treatment for individuals with moderate or severe tricuspid regurgitation, a condition where the heart's tricuspid valve fails to close properly, causing blood to flow backward. The procedure involves inserting a special ring into the heart using a thin tube and adjusting it after three months to assess its effectiveness. Individuals who continue to experience heart failure symptoms despite treatment and whose doctors have recommended this procedure may be suitable candidates. As an unphased trial, this study allows patients to contribute to innovative heart treatment research.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have a contraindication to anticoagulant therapy and dual antiplatelet therapy, which might suggest some medication adjustments could be necessary. It's best to discuss your specific medications with the trial team.

What prior data suggests that the CI Percutaneous Ring Annuloplasty System is safe for patients with tricuspid regurgitation?

Research has shown that the CI Percutaneous Ring Annuloplasty System has undergone safety testing in animals. These tests found no harmful reactions, and the device integrated well with surrounding tissue, suggesting potential safety for humans. However, animal tests do not always perfectly predict human outcomes.

This trial is an early feasibility study, marking one of the first instances of testing this device in humans. As a result, there may be limited human data available. At this early stage, researchers prioritize ensuring the treatment's safety for people. The absence of reported issues in animal studies is encouraging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The CI Percutaneous Ring Annuloplasty System is unique because it offers a minimally invasive approach to treating tricuspid regurgitation, a condition traditionally managed with open-heart surgery or medication. Unlike standard surgical methods, this system uses a catheter-based technique to place a ring around the tricuspid valve, potentially reducing recovery time and surgical risks. Researchers are excited about this treatment because it could provide a less invasive option for patients who are not ideal candidates for surgery, while still effectively improving heart valve function.

What evidence suggests that the CI Percutaneous Ring Annuloplasty System is effective for tricuspid regurgitation?

Research shows that the CI Percutaneous Ring Annuloplasty System can help a faulty heart valve close properly with a special ring. This system targets patients with moderate or severe tricuspid regurgitation, a condition where the heart valve doesn't close tightly, causing blood to flow backward. Studies of other similar rings have demonstrated better long-term results for patients with these issues. Early use of this specific device has shown successful adjustments and potential benefits in treating tricuspid regurgitation. The main goal is to improve heart function and reduce symptoms by supporting the valve's structure. ^{1 2 4 6 7}

Who Is on the Research Team?

Nodar Kipshidze, MPH

Principal Investigator

Cardiac Implants LLC

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My heart condition limits my physical activity.

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

A team of heart specialists agrees that a specific heart valve procedure is a good option for me.

Exclusion Criteria

I have moderate to severe heart valve issues.

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

Currently participating in another investigational drug or device study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation

Transcatheter delivery and implantation of the Cardiac Implants annuloplasty ring

1 day

1 visit (in-person)

Adjustment

Manual adjustment of the ring approximately 90 days following implantation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Multiple visits (in-person and virtual) at 30 days, 90 days, 180 days, 1 year, and annually up to 2 years post-adjustment

What Are the Treatments Tested in This Trial?

Interventions

• CI Percutaneous Ring Annuloplasty System

Trial Overview 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.

How Is the Trial Designed?

Group I: CI Percutaneous Ring Annuloplasty System Experimental Treatment 1 Intervention

Patients treated with the CI Percutaneous Ring Annuloplasty System

Who Is Running the Clinical Trial?

Cardiac Implants LLC

Lead Sponsor

Trials

2

Recruited

30+

Published Research Related to This Trial

The study successfully demonstrated the feasibility of using a transvenous valve-in-ring (VIR) implantation technique with the Melody valve in an ovine model, with technical success in 9 out of 10 sheep, indicating potential for this method in clinical settings.

No complications such as perivalvular leaks or left ventricular outflow tract obstruction were observed, suggesting that this percutaneous approach could be a safe and effective option for patients with failed mitral valve repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Melody valve-in-ring procedure for mitral valve replacement: feasibility in four annuloplasty types. Kondo, N., Shuto, T., McGarvey, JR., et al.[2021]

In a case study of a 76-year-old woman with severe aortic stenosis who had previously undergone mitral valve ring repair, the implantation of a self-expandable aortic valve was successful without any complications related to the mitral annuloplasty ring.

Echocardiography monitoring during the procedure showed no deformation or malfunction of the mitral ring, and there was no change in mitral function or regurgitation, suggesting that transcatheter aortic valve implantation can be safely performed in patients with prior mitral valve repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter self-expandable aortic valve implantation after undersized mitral annuloplasty. Bruschi, G., De Marco, F., Oreglia, J., et al.[2012]

The MC3 ring for tricuspid valve annuloplasty significantly improves the severity of tricuspid regurgitation (TR) shortly after surgery, with 16% of patients showing greater than moderate TR at 5 days post-operation, which decreased to 14% in those followed for over a year.

The effectiveness of the MC3 ring may surpass traditional techniques, but patients with severe leaflet tethering (greater than 1.0 cm) may need additional procedures to maintain valve function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Echocardiographic follow-up of tricuspid annuloplasty with a new three-dimensional ring in patients with functional tricuspid regurgitation. Fukuda, S., Gillinov, AM., McCarthy, PM., et al.[2022]

This study reports the first successful fully percutaneous implantation of a circumferential, semirigid annuloplasty ring to treat severe secondary tricuspid regurgitation, marking a significant advancement in transcatheter therapies.

The approach aims to replicate the gold standard surgical repair method, ring annuloplasty, which has been underexplored in non-surgical treatments for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-Human Percutaneous Circumferential Annuloplasty for Secondary Tricuspid Regurgitation. Reddy, VY., Abbo, AR., Ruiz, CE., et al.[2021]

The novel transcatheter mitral valve annuloplasty ring (AMEND™) demonstrated good biocompatibility in a study involving 6 minipigs, showing no adverse inflammatory responses and successful integration with host tissue.

While the device itself was well-tolerated, two animals experienced complications related to the implantation procedure, highlighting the need for careful monitoring during the procedure despite the overall favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biocompatibility and Systemic Safety of a Novel Implantable Annuloplasty Ring for the Treatment of Mitral Regurgitation in a Minipig Model. Ramot, Y., Rousselle, SD., Yellin, N., et al.[2018]

A novel interrupted pledgeted suture annuloplasty technique for tricuspid valve repair showed a high initial success rate, with 92.3% of patients free from moderate-severe regurgitation at 3 months post-surgery.

At 11 months post-surgery, 89.7% of patients maintained freedom from moderate-severe regurgitation, indicating good durability of the repair and suggesting this technique may be superior to existing suture annuloplasty methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective analysis of tricuspid valve repair using a novel surgical technique: A 7-year single-surgeon experience. Abdul Khader, A., Khan, H., Stowell, C., et al.[2021]

The new technique involves implanting a rigid tricuspid annuloplasty ring over an existing flexible ring to treat recurrent tricuspid regurgitation, which helps avoid the risks associated with removing the flexible ring.

This method is particularly beneficial for patients with fragile annular tissue, as it minimizes trauma during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placement of a rigid tricuspid annuloplasty ring over a flexible ring for the treatment of recurrent tricuspid regurgitation. Gualis, J., Castaño, M., Martínez-Comendador, JM., et al.[2016]

Transcatheter valve-in-valve and valve-in-ring procedures are effective methods for treating patients with failed bioprosthetic tricuspid valves and surgical repairs, indicating a growing acceptance of these techniques in clinical practice.

A case study demonstrated the successful percutaneous implantation of a Melody valve in a native tricuspid valve with severe stenosis, showcasing the potential for this approach even in the absence of a supporting annuloplasty ring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous melody valve implantation in a native tricuspid valve following failed surgical repair. Sumski, CA., Bartz, P., Gudausky, T.[2019]

In a study of 581 adult patients undergoing tricuspid ring annuloplasty, both the Duran AnCore and Edwards MC3 rings demonstrated similar safety profiles and durability in correcting tricuspid regurgitation over an average follow-up of 47 months.

There were no significant differences in early mortality, early complications, or recurrence of significant tricuspid regurgitation between the two types of annuloplasty rings, indicating that both options are effective for surgical treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medtronic Duran AnCore versus Edwards MC3 rings for tricuspid annuloplasty. Lee, SI., Kim, HJ., Kim, JB., et al.[2018]

The study introduced a new expandable annuloplasty ring designed to improve the implantation of transcatheter heart valves (THVs) for treating recurrent mitral regurgitation, showing promising results in preventing paravalvular leakage (PVL).

After deploying the THV, the ring successfully changed shape from oval to round, ensuring a secure fit without any gaps, indicating potential for better performance in future annuloplasty designs, although further studies are needed to assess long-term durability and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Mitral Annuloplasty Ring Enables Oversizing of Transcatheter Heart Valve and Prevents Central or Paravalvular Leakage. Duerr, GD., Sinning, JM., Welz, AG., et al.[2017]

Citations

1. withpower.com withpower.com/trial/phase-tricuspid-valve-insufficiency-6-2021-4012e

Percutaneous Ring Annuloplasty for Tricuspid Regurgitation 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8957110/

Impact of 3D Rigid Ring Annuloplasty for Tricuspid ... Tricuspid valve repair with an annuloplasty ring results in improved long-term outcomes. ... Efficiency of different annuloplasty in ...

3. citoday.com citoday.com/news/cardiac-implants-marks-initial-use-of-therapeutic-adjustment-procedure-with-tri-ring-percutaneous-annuloplasty-device

Cardiac Implants Marks Initial Use of Therapeutic ... Cardiac Implants Marks Initial Use of Therapeutic Adjustment Procedure With Tri-Ring Percutaneous Annuloplasty Device.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8299844/

First-in-Human Percutaneous Circumferential Annuloplasty for ... We describe the first-ever fully percutaneous implantation of a circumferential, semirigid annuloplasty ring to treat massive secondary tricuspid regurgitation.

5. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials?keyword=%22Annuloplasty%22

San Mateo Clinical Trials This study aims to compare whether De Vega's Suture annuloplasty is equally effective in reducing the progression of Functional Tricuspid regurgitation as ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9170310/

Innovative medical technologies in the percutaneous ... This paper presents data on the clinical efficacy, cost-effectiveness and expected population size for one of these procedures, namely the TriClip TTVr System ...

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.117.005840

First-in-Human Implantations of the NaviGate Bioprosthesis ... We report the first-in-human successful implantation of the NaviGate valved-stent (NaviGate Cardiac Structures, Inc, NCSI, Lake Forest, CA) in 2 patients with ...