Tricuspid valve regurgitation is a valve disease. The tricuspid valve sits between the two chambers of the heart on the right. The valve consists of three thin tissue flaps. These flaps open to facilitate the flow of blood from the upper chamber to the lower chamber. These are tightly closed, preventing the blood from flowing backward. However, in tricuspid valve regurgitation, the valve on the two heart chambers on the right doesn’t close tightly, causing the blood to leak backward and enter the right atrium.

Most often, people have tricuspid regurgitation by birth. Hence, it is also considered a congenital heart disease. But other causes include genetic disorders, rheumatic fever, carcinoid syndrome, heart lining infection, and chest injury. Tricuspid regurgitation may also occur because of the removal or placement of a pacemaker that crosses the patient’s tricuspid valve.

Symptoms characterize the disease once it becomes severe. The symptoms may include irregular heartbeat, shortness of breath, belly swelling, neck veins and legs, and fatigue.

Tricuspid regurgitation clinical trials observe the development of disease in patients, their response to treatment, and the effects of medication on the progression of the disease.

Why Is Tricuspid Regurgitation Being Studied Through Clinical Trials?

Tricuspid valve regurgitation is the most common type of valvular cardiac disease. It is likely to affect 65 percent to 85 percent of the population. However, the severity of the condition is observed in approximately 1.6 million patients in the United States. The condition may become severe in patients with high blood pressure, pulmonary hypertension, cardiomyopathy, and those who seek medication for migraines. Moreover, tricuspid regurgitation results in complications like atrial fibrillation and heart failure. Hence tricuspid regurgitation clinical trials are underway to counter the issue.

Furthermore, trials are essential to finding the best and most effective preventative methods and cures for tricuspid valve regurgitation.

What Are the Types of Treatments Available for Tricuspid Regurgitation?

Depending on the tricuspid valve regurgitation severity, the doctor may advise you on medication or surgery. Medication helps address and manage uncomfortable symptoms like irregular heartbeat and swelling. It also prevents water retention while controlling the heart rate. However, surgery is needed to replace or repair the valve.

Tricuspid surgery uses general anesthesia to perform the surgery and keep the patient comfortable. The bypass machine is used for pumping blood during the procedure. Several tiny incisions are made in the chest, and one large incision is made on the right side of the chest. The damaged valve is repaired or replaced as needed. Next, the bypass machine is removed to ensure proper heart functioning, and incisions are closed.

What Are Some Recent Breakthrough Clinical Trials for Tricuspid Regurgitation?

2023: Tricuspid Valve Repair System Shows Promising Results at One-Year Follow-Up- In this feasibility study of the ITR (investigational transcatheter repair) system and one-year follow-up, results concluded with data from 36 patients. All patients experienced a reduction in one grade severity of tricuspid valve regurgitation, while 75 percent saw two grade reductions.

2023: Surgical management of tricuspid regurgitation- This observational and single-center study was performed on 76 patients with tricuspid regurgitation aimed to determine the algorithm efficacy of residual tricuspid regurgitation after tricuspid valve surgery. The study hypothesized that the tricuspid regurgitation rate after one year would be lowered by choosing the surgical approach in conformance with the preoperative echocardiographic and clinical variables. It was concluded that TR proved functional in 69.9 percent of the patients. More research needs to be conducted to confirm the findings.

Who Are Some of the Key Opinion Leaders/Researchers/Institutions Conducting Tricuspid Regurgitation Clinical Trial Research?

NYU Langone Health Heart Valve Center

The team at HVC has over 40 years of heart valve replacement and repair experience. From intensive research to medical care, they are innovators and experts caring for people with tricuspid and aortic diseases.

Heart Valve Translational Research Program

It targets the unmet medical and clinical needs of patients with heart valve diseases. The program conducts research to find effective treatments.

About The Author

Michael Gill - B. Sc.

First Published: October 18th, 2021

Last Reviewed: August 25th, 2023

References¹ Davidson CJ, Lim DS, Smith RL, Kodali SK, Kipperman RM, Eleid MF, Reisman M, Whisenant B, Puthumana J, Abramson S, Fowler D, Grayburn P, Hahn RT, Koulogiannis K, Pislaru SV, Zwink T, Minder M, Dahou A, Deo SH, Vandrangi P, Deuschl F, Feldman TE, Gray WA; Cardioband TR EFS Investigators. Early Feasibility Study of Cardioband Tricuspid System for Functional Tricuspid Regurgitation: 30-Day Outcomes. JACC Cardiovasc Interv. 2021 Jan 11;14(1):41-50. doi: 10.1016/j.jcin.2020.10.017. https://pubmed.ncbi.nlm.nih.gov/33413863² Davidson CJ, Abramson S, Smith RL, Kodali SK, Kipperman RM, Eleid MF, Reisman M, Whisenant BK, Puthumana J, Fowler D, Grayburn PA, Hahn RT, Koulogiannis K, Pislaru SV, Zwink T, Minder M, Deuschl F, Feldman T, Gray WA, Lim DS; Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study Investigators. Transcatheter Tricuspid Repair With the Use of 4-Dimensional Intracardiac Echocardiography. JACC Cardiovasc Imaging. 2022 Mar;15(3):533-538. doi: 10.1016/j.jcmg.2021.01.029. Epub 2021 Mar 17. https://pubmed.ncbi.nlm.nih.gov/33744150³ Kodali S, Hahn RT, George I, Davidson CJ, Narang A, Zahr F, Chadderdon S, Smith R, Grayburn PA, O'Neill WW, Wang DD, Herrmann H, Silvestry F, Elmariah S, Inglessis I, Passeri J, Lim DS, Salerno M, Makar M, Mack MJ, Leon MB, Makkar R; TRISCEND Investigators. Transfemoral Tricuspid Valve Replacement in Patients With Tricuspid Regurgitation: TRISCEND Study 30-Day Results. JACC Cardiovasc Interv. 2022 Mar 14;15(5):471-480. doi: 10.1016/j.jcin.2022.01.016. https://pubmed.ncbi.nlm.nih.gov/35272771⁴ Nickenig G, Weber M, Lurz P, von Bardeleben RS, Sitges M, Sorajja P, Hausleiter J, Denti P, Trochu JN, Näbauer M, Dahou A, Hahn RT. Transcatheter edge-to-edge repair for reduction of tricuspid regurgitation: 6-month outcomes of the TRILUMINATE single-arm study. Lancet. 2019 Nov 30;394(10213):2002-2011. doi: 10.1016/S0140-6736(19)32600-5. Epub 2019 Nov 7. Erratum in: Lancet. 2020 Mar 14;395(10227):870. https://pubmed.ncbi.nlm.nih.gov/31708188⁵ Davidson CJ, Abramson S, Smith RL, Kodali SK, Kipperman RM, Eleid MF, Reisman M, Whisenant BK, Puthumana J, Fowler D, Grayburn PA, Hahn RT, Koulogiannis K, Pislaru SV, Zwink T, Minder M, Deuschl F, Feldman T, Gray WA, Lim DS; Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study Investigators. Transcatheter Tricuspid Repair With the Use of 4-Dimensional Intracardiac Echocardiography. JACC Cardiovasc Imaging. 2022 Mar;15(3):533-538. doi: 10.1016/j.jcmg.2021.01.029. Epub 2021 Mar 17. No abstract available. https://pubmed.ncbi.nlm.nih.gov/33744150⁶ Kodali S, Hahn RT, Eleid MF, Kipperman R, Smith R, Lim DS, Gray WA, Narang A, Pislaru SV, Koulogiannis K, Grayburn P, Fowler D, Hawthorne K, Dahou A, Deo SH, Vandrangi P, Deuschl F, Mack MJ, Leon MB, Feldman T, Davidson CJ; CLASP TR EFS Investigators. Feasibility Study of the Transcatheter Valve Repair System for Severe Tricuspid Regurgitation. J Am Coll Cardiol. 2021 Feb 2;77(4):345-356. doi: 10.1016/j.jacc.2020.11.047. https://pubmed.ncbi.nlm.nih.gov/33509390⁷ Gammie JS, Chu MWA, Falk V, Overbey JR, Moskowitz AJ, Gillinov M, Mack MJ, Voisine P, Krane M, Yerokun B, Bowdish ME, Conradi L, Bolling SF, Miller MA, Taddei-Peters WC, Jeffries NO, Parides MK, Weisel R, Jessup M, Rose EA, Mullen JC, Raymond S, Moquete EG, O'Sullivan K, Marks ME, Iribarne A, Beyersdorf F, Borger MA, Geirsson A, Bagiella E, Hung J, Gelijns AC, O'Gara PT, Ailawadi G; CTSN Investigators. Concomitant Tricuspid Repair in Patients with Degenerative Mitral Regurgitation. N Engl J Med. 2022 Jan 27;386(4):327-339. doi: 10.1056/NEJMoa2115961. Epub 2021 Nov 13. https://pubmed.ncbi.nlm.nih.gov/34767705⁸ Gammie JS, Chu MWA, Falk V, Overbey JR, Moskowitz AJ, Gillinov M, Mack MJ, Voisine P, Krane M, Yerokun B, Bowdish ME, Conradi L, Bolling SF, Miller MA, Taddei-Peters WC, Jeffries NO, Parides MK, Weisel R, Jessup M, Rose EA, Mullen JC, Raymond S, Moquete EG, O'Sullivan K, Marks ME, Iribarne A, Beyersdorf F, Borger MA, Geirsson A, Bagiella E, Hung J, Gelijns AC, O'Gara PT, Ailawadi G; CTSN Investigators. Concomitant Tricuspid Repair in Patients with Degenerative Mitral Regurgitation. N Engl J Med. 2021 Nov 13. doi: 10.1056/NEJMoa2115961. [Epub ahead of print] https://pubmed.ncbi.nlm.nih.gov/34767705⁹ Lurz P, Kresoja KP. Tricuspid Valve Therapies: Closing the Gap. JACC Cardiovasc Interv. 2021 Jun 14;14(11):1241-1242. doi: 10.1016/j.jcin.2021.04.008. https://pubmed.ncbi.nlm.nih.gov/34112461¹⁰ Lurz P, Kresoja KP. Tricuspid Valve Therapies: Closing the Gap. JACC Cardiovasc Interv. 2021 Jun 14;14(11):1241-1242. doi: 10.1016/j.jcin.2021.04.008. No abstract available. https://pubmed.ncbi.nlm.nih.gov/34112461