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Transcatheter Heart Valve Therapies for the Tricuspid Valve

As one of the highest volume and most experienced transcatheter tricuspid valve programs in the nation, Northwestern Medicine continues to expand its Transcatheter Heart Valve Program by offering a wide array of clinical trials for the tricuspid valve.

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Transcatheter Tricuspid Heart Valve Therapies: Setting the Pace With “First in Human” Clinical Trials

Tricuspid valve disease impacts 1.6 million people in the United States each year. Tricuspid valve regurgitation occurs when the tricuspid valve does not close completely, allowing blood to flow backward or “leak,” creating symptoms that include shortness of breath, fatigue and abnormal heart rhythms. Because medical therapy to treat tricuspid valve regurgitation is often ineffective and surgical repair is associated with a high complication rate, transcatheter treatment options are ideal for the tricuspid valve.

Transcatheter heart valve therapies are minimally invasive procedures to repair a diseased heart valve that involves threading a catheter (tube) through a small incision made in the skin. The device needed to repair the diseased valve is placed in the catheter and fed through a vein in the body until it reaches the diseased heart valve.

Transcatheter heart valve therapies offer some patients an alternative to open heart valve surgery. These minimally invasive transcatheter therapies allow the procedure to be performed while the patient’s heart is still beating, eliminating the need for a “bypass” machine and its associated risks. Due to the minimally invasive nature of transcatheter procedures, patients recover faster and experience an improvement in symptoms soon after the procedure is completed.

Transcatheter Tricuspid Valve Clinical Trial Options

Researchers at Northwestern Medicine conduct clinical trials that provide access to innovative therapies for the treatment of heart and vascular disease. Participating in a clinical trial is an opportunity to evaluate the effectiveness and safety of medications or study devices. The study devices and delivery systems used in the following clinical trials are investigational (experimental), which means they are not approved for commercial use by the U.S. FDA.

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CLASP II TR Pivotal: enrolling patients to evaluate the Edwards PASCAL Transcatheter Tricuspid Valve Repair System in patients with tricuspid regurgitation. The PASCAL tricuspid clip is an edge-to-edge valve repair with a spacer in the center of the clip that can treat both functional and degenerative tricuspid disease. Once attached to the leaflets, the PASCAL implant will act as a filler to help reduce tricuspid regurgitation.

Northwestern Medicine is also among the most experienced programs in the country for transcatheter treatment options for the aortic valve and the mitral valve. 

Northwestern Memorial Hospital is ranked as a top ten program in the nation (No. 7) for cardiology, heart & vascular surgery by U.S. News & World Report, 2024 - 2025. Our impressive U.S. News & World Report achievements are a reflection of the expert care provided and why patients choose to get their heart and vascular seconds opinions from Northwestern Medicine.

• Highest ranked cardiology, heart & vascular surgery program in Illinois for 17 consecutive years
• Highest available cardiology, heart & vascular surgery patient survival score since the metric was introduced
• Rated “High Performing” (the highest rating possible) for abdominal aortic aneurysm repair, aortic valve surgery, heart attack, heart failure and transcatheter aortic valve replacement (TAVR)

Transcatheter Tricuspid Heart Valve Featured Publications

1. Gercek M, Goncharov A, Narang A, Korber ML, Friedrichs KP, Baldridge AS, Meng Z, Puthumana JJ, Davidson LJ, Malaisrie SC, Thomas JD, Rudolph TK, Pfister R, Rudolph V, Davidson CJ. Characterization of Screen Failures Among Patients Evaluated for Transcatheter Tricuspid Valve Repair (TriSelect-Study). JACC Cardiovasc Interv. 2023;16(13): 1579-1589. doi: 10.1016/j.jcin.2023.03.036.
2. McCarthy PM. Help Wanted: New Options for Tricuspid Valve Repair. The Annals of Thoracic Surgery. 2022;114(3): 832-833. doi: 10.1016/j.athoracsur.2022.02.002.
3. Chadderdon SM, Eleid MF, Thaden JJ, Makkar R, Nakamura M, Babaliaros V, Greenbaum A, Gleason P, Kodali S, Hahn RT, Koulogiannis KP, Marcoff L, Grayburn P, Smith RL, Song HK, Lim DS, Gray WA, Hawthorne K, Deuschl F, Narang A, Davidson C, Zahr FE. Three-Dimensional Intracardiac Echocardiography for Tricuspid Transcatheter Edge-to-Edge Repair. Structural Heart Journal. 2022;6(4): doi: 10.1016/j.shj.2022.100071.
4. 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;15(5):471-480. doi: 10.1016/j.jcin.2022.01.016.
5. Ranard LS, Vahl TP, Chung CJ, Sadri S, Khalique OK, Hamid N, Nazif T, George I, Ng V, Patel A, Rezende CP, Reisman M, Latib A, Hausleiter J, Sorajja P, Bapat VN, Tang GHL, Davidson CJ, Zahr F, Makkar R, Fam NP, Granada JF, Leon MB, Hahn RT, Kodali S. Impact of inferior vena cava entry characteristics on tricuspid annular access during transcatheter interventions. Catheter Cardiovasc Interv. 2022. doi: 10.1002/ccd.30048.
6. 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, on behalf of the Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study Investigators. Transcatheter Tricuspid Repair With the Use of 4-Dimensional Intracardiac Echocardiography. JACC Cardiovasc Imaging. 2021;S1936-878X(21)00153-4. doi: 10.1016/j.jcmg.2021.01.029.
7. Kitamura M, Fam NP, Braun D, Ruf T, Sugiura A, Narang A, Connelly KA, Ho E, Nabauer M, Hausleiter J, Weber M, Nickenig G, Davidson CJ, Thiele H, von Bardeleben RS, Lurz P. 12-Month outcomes of transcatheter tricuspid valve repair with the PASCAL system for severe tricuspid regurgitation. Catheter Cardiovasc Interv. 2021. doi: 10.1002/ccd.29583.
8. 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, on behalf of the CLASP TR EFS Investigators. Feasibility Study of the Transcatheter Valve Repair System for Severe Tricuspid Regurgitation. J Am Coll Cardiol. 2021;77(4):345-356. doi: 10.1016/j.jacc.2020.11.047.
9. 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;14(1):41-50. doi: 10.1016/j.jcin.2020.10.017.
10. Peters AC, Unger E, Gong FF, El Hangouche N, Puthumana JJ, Thomas JD, Fusari M, Davidson CJ, Ricciardi MJ, Pham D, Flaherty JD, Narang A. Multimodality imaging to guide transcatheter treatment of severe degenerative tricuspid regurgitation with tricuspid valve-in-ring implantation and paravalvular leak closure. Echocardiography. 2020;37(6): 913-916. doi: 10.1111/echo.14743.
11. Fam NP, Braun D, von Bardeleben RS, Nabauer M, Ruf T, Connelly KA, Ho E, Thiele H, Lurz P, Weber M, Nickenig G, Narang A, Davidson C, Hausleiter J. Compassionate Use of the PASCAL Transcatheter Valve Repair System for Severe Tricuspid Regurgitation. J Am Coll Cardiol Intv. 2019;(24) 2488-2495; doi: 10.1016/j.jcin.2019.09.046.

*Bolding of author’s name indicates Northwestern Medicine and/or Northwestern University Feinberg School of Medicine faculty.

Whether you are experiencing symptoms that you do not understand or have already been diagnosed and require tricuspid heart valve therapy, or are looking for a second opinion, Northwestern Medicine Bluhm Cardiovascular Institute offers comprehensive expertise to you and your loved ones at multiple convenient locations.

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Northwestern Medicine Bluhm Cardiovascular Institute is a nationally recognized destination for those who require highly specialized heart and vascular care.

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312.NM.HEART (312.664.3278)

TANDEM: The purpose of this early feasibility study is to evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System) in patients with severe or greater tricuspid regurgitation. The DUO System is designed to assist the native coaptation of the tricuspid valve and is placed via a minimally invasive approach. Up to 15 eligible participants will receive the investigational valve and be followed for 5 years.

TRICURE EFS: The purpose of this early feasibility study is to assess the safety of the Topaz Transfemoral Tricuspid Heart Valve Replacement (TTVR) System in patients presenting with symptomatic severe or greater regurgitation who are suitable for valve replacement. The TRiCares Topaz TTVR is intended to replace the native tricuspid heart valve via a minimally invasive transcatheter approach without removing the native valve. Up to 15 eligible participants will receive the investigational valve and be followed for 5 years.