Transcatheter Tricuspid Valve Reconstruction for Tricuspid Regurgitation

Not currently recruiting at 10 trial locations

Overseen By TMTT Clinical

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Edwards Lifesciences

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Severe valve stenosis, Active infection, Recent stroke, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 31

Duration: 2-7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Edwards Cardioband FIT Repair System for individuals with tricuspid regurgitation, a condition where the heart's tricuspid valve fails to close properly, causing blood to flow backward. The trial aims to determine if this treatment can improve symptoms for those who haven't found success with other treatments. Suitable candidates have moderate or more severe tricuspid regurgitation and have experienced symptoms or hospitalizations related to this condition despite medication. As an unphased trial, this study provides patients the opportunity to explore a new treatment option that could potentially enhance their quality of life.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have a hypersensitivity or contraindication to antiplatelets, anticoagulants, or other specified materials, you may not be eligible to participate.

What prior data suggests that the Edwards Cardioband Tricuspid Valve Reconstruction System is safe?

Research has shown that the Edwards Cardioband Tricuspid Valve Reconstruction System is safe. Studies found that after one year, patients using this system had high survival rates and required fewer hospital visits. The positive results remained stable over time, even up to two years in some cases, suggesting that the treatment is well-tolerated with few serious side effects.

The safety and effectiveness of this system continue to be studied, but the initial data is encouraging. While specific details on side effects aren't provided, the overall findings indicate a low risk for those considering joining related clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for tricuspid regurgitation, which typically involves open-heart surgery for valve repair or replacement, the Edwards Cardioband Tricuspid Valve Reconstruction System offers a less invasive alternative. This system is unique because it utilizes a transcatheter approach, threading a device through a vein to reach the heart, which can reduce recovery time and lower risks associated with surgery. Researchers are excited about this treatment because it targets the tricuspid valve directly, potentially improving heart function and patient outcomes without the need for major surgery.

What evidence suggests that the Edwards Cardioband Tricuspid Valve Reconstruction System is effective for tricuspid regurgitation?

Research has shown that the Edwards Cardioband Tricuspid Valve Reconstruction System, which participants in this trial will receive, holds promise for treating tricuspid regurgitation, a heart valve issue. Studies found that patients using this system had high survival rates and fewer hospital visits one year after the procedure. Early results also showed improvements just 30 days after treatment, even for those with severe symptoms. This system offers a long-lasting and less invasive option for individuals with this condition. Overall, the Cardioband system has demonstrated positive results in improving patient health. ^{1 2 4 6 7}

Who Is on the Research Team?

William Gray, MD

Principal Investigator

Lankenau Heart

Firas Zahr, MD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for adults with chronic functional tricuspid regurgitation (moderate or greater) who still have symptoms despite medical treatment. Candidates should be deemed appropriate for the procedure by a Heart Team but cannot have unsuitable anatomy, primary valve disease, prior repairs or replacements, or conditions that may affect study participation.

Inclusion Criteria

I have a long-term moderate or severe leak in my heart valve.

I have heart issues related to tricuspid regurgitation that aren't improving with current treatment.

My heart team has approved me for a specific heart valve procedure.

Exclusion Criteria

My body's structure makes me ineligible for the procedure.

My heart condition is related to the tricuspid valve.

Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with the Edwards Cardioband FIT Repair System

2-7 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Multiple visits (in-person) at 30 days and 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Edwards Cardioband Tricuspid Valve Reconstruction System

Trial Overview The Edwards Cardioband Tricuspid Valve Reconstruction System is being tested in this clinical study. It's a minimally invasive procedure designed to repair the heart's tricuspid valve without needing open-heart surgery.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Treatment with the Edwards Cardioband FIT Repair System

Edwards Cardioband Tricuspid Valve Reconstruction System is already approved in European Union for the following indications:

Approved in European Union as Edwards Cardioband Tricuspid Valve Reconstruction System for:

• Tricuspid regurgitation

Who Is Running the Clinical Trial?

Edwards Lifesciences

Lead Sponsor

Trials

188

Recruited

67,500+

Founded

1958

Headquarters

Irvine, California, U.S.

Known For

Structural Heart Innovations

Top Products

SAPIEN Transcatheter Heart Valve, EVOQUE System, PASCAL Precision, SAPIEN M3

Todd Brinton

Edwards Lifesciences

Chief Medical Officer since 2023

MD from Stanford University

Bernard Zovighian

Edwards Lifesciences

Chief Executive Officer since 2023

MBA from INSEAD

Published Research Related to This Trial

In a case involving a 74-year-old male undergoing percutaneous balloon compression for trigeminal neuralgia, recurrent episodes of bradycardia or sinus arrest occurred during the procedure, which were managed by maintaining a high heart rate with isoproterenol infusion.

Despite the administration of atropine and lidocaine not preventing the recurrence of the trigeminocardiac reflex, the continuous use of isoproterenol allowed the procedure to be completed successfully, and the patient had a quick recovery with no discomfort reported at the six-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recurrent trigeminocardiac reflex in percutaneous balloon compression for trigeminal neuralgia: A case report. Qin, Q., Wang, Y.[2022]

Endovascular embolization is the preferred treatment for carotid-cavernous fistulas (CCFs), which are abnormal connections between the carotid artery and the cavernous sinus.

During the embolization procedure, the trigeminocardiac reflex (TCR) can cause severe bradycardia, highlighting the need for careful intraoperative management to maintain hemodynamic stability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-Arterial Lidocaine Blunts the Trigeminocardiac Reflex during Endovascular Treatment of a Carotid-Cavernous Fistula. Coleman, RL., Bezinover, D., Jones, DC., et al.[2021]

In a study involving 30 patients with severe functional tricuspid regurgitation, the Cardioband tricuspid valve reconstruction system demonstrated a high procedural success rate of 93% and no 30-day mortality, indicating its safety and feasibility for this patient population.

At 30 days post-procedure, 85% of patients experienced at least a one-grade reduction in tricuspid regurgitation, with significant improvements in functional status as evidenced by a 16-point increase in quality of life scores and a shift from more severe heart failure classes to milder ones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Feasibility Study of Cardioband Tricuspid System for Functional Tricuspid Regurgitation: 30-Day Outcomes. Davidson, CJ., Lim, DS., Smith, RL., et al.[2021]

In a case report of temporomandibular joint (TMJ) replacement surgery, iatrogenic injuries to the middle meningeal and superficial temporal arteries were effectively managed using a gelatin-based hemostatic agent.

This highlights the potential for gelatin-based agents to control vascular complications during TMJ surgery, which can involve significant risks such as nerve and blood vessel damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of middle meningeal and superficial temporal artery hemorrhage from total temporomandibular joint replacement surgery with a gelatin-based hemostatic agent. Cillo, JE., Sinn, D., Truelson, JM.[2019]

Transcatheter tricuspid valve intervention (TTVI) using the Cardioband was successfully performed on a 78-year-old woman with severe tricuspid regurgitation, resulting in a significant reduction of the condition as confirmed by echocardiography.

During the procedure, a complication occurred where the cinching wire became tangled around the Dacron band, highlighting a potential risk that clinicians should be aware of when performing TTVI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tangled wire in a Dacron band during Cardioband transcatheter tricuspid annuloplasty-How to solve the problem. Miura, M., Vicentini, L., Taramasso, M., et al.[2021]

In a study of 51 patients undergoing Cardioband implantation for tricuspid regurgitation, 14 patients experienced acute deformation of the right coronary artery (RCA) during the procedure.

Follow-up angiographies showed that all cases of RCA deformation resolved completely without any clinical symptoms, suggesting that this complication is reversible and that a watchful waiting approach is safe and effective, avoiding unnecessary interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transient acute right coronary artery deformation during transcatheter interventional tricuspid repair with the Cardioband tricuspid system. Gerçek, M., Rudolph, V., Arnold, M., et al.[2023]

In a study of 60 patients with moderate to severe mitral regurgitation, the Cardioband™ procedure showed a high technical success rate of 97%, with 61% of patients experiencing moderate or less mitral regurgitation after one year.

Patients also reported significant improvements in functional status and quality of life, with 79% achieving New York Heart Association Class I/II status and a notable increase in exercise capacity, indicating the procedure's efficacy in enhancing patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter mitral valve repair for functional mitral regurgitation using the Cardioband system: 1 year outcomes. Messika-Zeitoun, D., Nickenig, G., Latib, A., et al.[2020]

A 4-year-old child with severe right heart failure due to a malfunctioning bioprosthetic tricuspid valve underwent a successful percutaneous valve-in-valve procedure using an Edwards S3 valve.

The procedure was performed without complications and resulted in significant improvement in the child's clinical condition, highlighting its potential as a safe and effective intervention for similar cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tricuspid valve in valve procedure with an Edwards S3 valve© in a 10 kg child. Betrián-Blasco, P., Marti-Aguasca, G., Giralt-García, G.[2022]

The Cardioband system is a catheter-delivered device that effectively reduces mitral valve regurgitation in patients, showing safe deployment and significant improvements in quality of life and exercise capacity.

The ongoing ACTIVE Trial aims to prove that the Cardioband system is superior to standard medical therapy for treating functional mitral regurgitation, focusing on key outcomes like mortality and heart failure hospitalizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Cardioband transcatheter annular reduction system. Miller, M., Thourani, VH., Whisenant, B.[2020]

The rhino-cardiac reflex, a rare type of trigeminal-cardiac reflex, can lead to sudden cardiac arrest during nasal cavity disinfection, as demonstrated in two reported cases during pituitary surgery.

Both patients experienced a rapid drop in heart rate that quickly recovered after stopping the nasal stimulation and administering cardiac support, highlighting the need for anesthesiologists to be vigilant and prepared for this rare but serious reflex.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case report: 2 cases of cardiac arrest caused by rhino-cardiac reflex while disinfecting nasal cavity before endonasal transsphenoidal endoscopic pituitary surgery. Wang, W., Cai, H., Ding, H., et al.[2021]

The Cardioband® tricuspid valve reconstruction system can effectively adjust ring size but poses a risk of causing subtotal occlusion of the right coronary artery (RCA), as demonstrated in a reported patient case.

This complication can be challenging to treat, as traditional methods of re-canalization may fail, necessitating alternative approaches for successful intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subtotal occlusion of the right coronary artery by Cardioband and its successful intervention via retrograde approach. Interventional flashlight. Habedank, D., Bierschenk, S., Zimpel, S., et al.[2023]

In a study of 111 patients undergoing non-surgical root canal treatment (NSRCT) for irreversible pulpitis, significant drops in mean arterial blood pressure (MABP) were observed, particularly during the first session where vital pulp was removed, indicating a potential link to the trigeminocardiac reflex (TCR).

The incidence of MABP decreases of 10% or more was notably higher in the first session compared to the second, and this effect was more pronounced in patients with premolar teeth, suggesting that tooth type may influence hemodynamic responses during dental procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trigeminocardiac reflex during non-surgical root canal treatment of teeth with irreversible pulpitis. Huang, JI., Chang, HH., Lin, CP., et al.[2018]

Citations

1. jacc.org jacc.org/doi/10.1016/j.jcin.2022.07.006

1-Year Outcomes of Cardioband Tricuspid Valve ... One-year experience using the Cardioband system for tricuspid valve repair shows high survival and low rehospitalization rates with durable outcomes.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36202561/

1-Year Outcomes of Cardioband Tricuspid Valve ... One-year experience using the Cardioband system for tricuspid valve repair shows high survival and low rehospitalization rates with durable outcomes.

3. eurointervention.pcronline.com eurointervention.pcronline.com/article/thirty-day-outcomes-of-the-cardioband-tricuspid-system-for-patients-with-symptomatic-functional-tricuspid-regurgitation-the-triband-study

Thirty-day outcomes of the Cardioband tricuspid system for ... The Cardioband tricuspid system demonstrated favourable outcomes at discharge and 30 days in a challenging patient population with symptomatic ≥severe ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03382457

Clinical Study of Edwards Cardioband FIT Valve Repair ... Edwards Cardioband Tricuspid Valve Repair ... Early Feasibility Study of Cardioband Tricuspid System for Functional Tricuspid Regurgitation: 30-Day Outcomes.

5. icrjournal.com icrjournal.com/articles/tricuspid-regurgitation-clinical-case-based-review-edwards-cardiobandtm-tricuspid-valve?language_content_entity=en

Tricuspid Regurgitation: A Clinical Case-Based Review Of ... The Edwards Cardioband™ tricuspid valve reconstruction system is a transvenous system to treat TR. It is the first commercially available transcatheter therapy ...

6. eurointervention.pcronline.com eurointervention.pcronline.com/article/two-year-outcomes-with-the-cardioband-tricuspid-system-from-the-multicentre-prospective-tri-repair-study

Tricuspid valve repair with the Cardioband system We report one- and two-year outcomes of the Cardioband tricuspid valve reconstruction system in the treatment of ≥moderate functional TR in the TRI-REPAIR study ...

7. mayo.edu mayo.edu/research/clinical-trials/cls-20440978

Edwards Cardioband™ Tricuspid Valve Reconstruction ... The purpose of this early feasibility study is to assess the safety and performance of the Edwards Cardioband™ FIT Valve Repair System.