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, including Cardioband TR EFS and CLASP II TR Pivotal.

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.

The Transcatheter Heart Valve Program at Northwestern Medicine offers a variety of transcatheter clinical trial options for the tricuspid valve, allowing us to tailor treatment precisely to each patient’s individual needs. Northwestern Medicine has done three “first in human” transcatheter clinical trials related to the tricuspid valve, positioning our program to have the most experience with transcatheter tricuspid heart valve clinical trials in the country. Cardioband TR EFS and PASCAL CLASP TR EFS are transcatheter clinical trials for the tricuspid valve that work to decrease the size (annular reduction) of the tricuspid valve causing the regurgitation. Cardioband TR EFS treats tricuspid regurgitation by placing a ring around the tricuspid valve opening, helping the valve to close completely. PASCAL CLASP TR EFS treats tricuspid regurgitation by joining or clipping together a portion of the tricuspid valve, helping the valve to close completely.

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.

PASCAL Implant

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.

cend-fsTRISCEND II Pivotal: a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the EVOQUE System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with at least severe tricuspid regurgitation. Subjects will be followed at discharge, 30 days, 3 months, 6 months and annually through 5 years.

Clinical Study of Edwards Cardioband:
This multi-center, single-arm, non-randomized study is being conducted to evaluate the safety and performance of the Edwards Cardioband Tricuspid Valve Reconstruction System in patients with clinically significant, symptomatic functional tricuspid regurgitation (TR) despite medical therapy. The primary safety endpoint is freedom from device or procedure-related major adverse events at 30 days.

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

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    Related Resources

    Northwestern Medicine Transcatheter Tricuspid Featured Publications

    1. 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 Jan 27. doi: 10.1002/ccd.30048. Epub ahead of print. PMID: 35084803.
    2. 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. PMID: 35272771.
    3. 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. PMID: 33413863.

    4. 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 Feb 2;77(4):345-356. doi: 10.1016/j.jacc.2020.11.047.PMID: 33509390

    5. 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 Mar 10:S1936-878X(21)00153-4. doi: 10.1016/j.jcmg.2021.01.029
    6. 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 Mar 4. Doi: 10.1002/ccd.29583. Epub ahead of print. PMID: 33660364

    7. 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 Dec, 12 (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.