Six months data from CLASP IID trial of PASCAL system, confirming TEER as safe and effective for degenerative mitral regurgitation (DMR) in first head to head trial
Edwards Lifesciences Corporation announced results from CLASP IID, the first randomized controlled trial that directly compares two contemporary transcatheter edge-to-edge repair (TEER) therapies. The study confirms TEER as a safe and effective therapy in patients with degenerative mitral regurgitation (DMR)
Results from the CLASP IID pivotal trial were presented as a late-breaking clinical science session at the 34th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, and published simultaneously in JACC: Cardiovascular Interventions.
Patients enrolled in the CLASP IID pivotal trial had severe symptomatic DMR and were determined to be at prohibitive surgical risk. The CLASP IID trial met its primary safety and effectiveness endpoints, with the PASCAL system demonstrating non-inferiority for safety and effectiveness compared to the MitraClip device. The PASCAL device showed: i. Low composite major adverse event rate of 3.4 percent at 30 days, and ii. Significant and sustained MR reduction with 97.7 percent of patients achieving MR ?2+ at six months. The PASCAL system further demonstrated significant and sustained MR less than 1+ with 83.7 percent of patients at MR less than 1+ at six months. PASCAL system results also showed favorable ventricular remodeling with improved stroke volume, and patients receiving the PASCAL system experienced significant improvements in functional capacity and quality of life.
The CLASP IID trial is a prospective randomized controlled trial comparing the safety and effectiveness of the PASCAL system to the MitraClip system . Results were reported on 180 patients with 2:1 randomization (117 PASCAL / 63 MitraClip), with echo core lab adjudication. The trial included 43 sites in the US, Canada and Europe, with most clinical operators new to using the PASCAL system and all having experience with the MitraClip system.
"As we consider the many DMR patients who are suffering with debilitating symptoms and could benefit from a TEER procedure, we are very pleased with the outcomes from the CLASP IID trial," said Bernard J. Zovighian, Edwards' corporate vice president, transcatheter mitral and tricuspid therapies. "Edwards continues to prioritize evidence generation with world-class data in support of our patient-driven therapies, and we are proud to support this and multiple other pivotal trials as we work to transform treatment for these patients in need."
Additional data presentations for the company during TCT 2022 include :1.The PASCAL IID Registry: A Prospective Registry for Transcatheter Edge-to-Edge Repair in Prohibitive Risk Patients With Degenerative Mitral Regurgitation and Complex Mitral Valve Anatomy (Sept. 17) – Late-Breaking Presenter: Jörg Hausleiter. 2.Deep Dive Session: Mitral TEER = CLASP IID Trials (Sept. 17) – Moderators: Megan Coylewright, Linda D. Gillam. Discussants: Paul A. Grayburn, Konstantinos P. Koulogiannis, Raj Makkar, Jacob M. Mishell, Ralph Stephan von Bardeleben, Firas Zahr. 3. Frequency and Safety of Bioprosthetic Valve Fracture in Patients Undergoing Valve in Valve TAVR for Failed Surgical Valves Using the SAPIEN 3/Ultra Valves: Insights From Real-World Data (Sept. 18) – Presenter: Santiago Garcia. 4. Cardiac Damage and Quality of Life After Aortic Valve Replacement: Results from the PARTNER Trials (Sept. 18) – Presenter: Philippe Genereux.
As part of Edwards' continued commitment to building a body of real-world evidence, patients receiving the PASCAL Precision therapy in the US will be enrolled in the TVT Registry for five years.
The PASCAL Precision system is one of multiple transcatheter repair or replacement therapies in development by Edwards and the company's first approved transcatheter therapy for DMR in the US. The PASCAL system first received CE Mark in Europe in 2019, and the PASCAL Precision system received CE Mark in 2022.
About TEER ;Transcatheter Edge-to-Edge Repair (TEER) of the mitral valve is used in the treatment of mitral regurgitation. TEER approximates the anterior and posterior mitral valve leaflets by grasping them with a clipping device in an approach similar to a treatment developed in cardiac surgery called the Alfieri stitch.
See- "Randomized Comparison of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients":D. Scott Lim, Robert L. Smith, Linda D. Gillam, Firas Zahr, Scott Chadderdon, Raj Makkar, Ralph Stephan von Bardeleben, Robert M. Kipperman, Andrew N. Rassi, Molly Szerlip, Scott Goldman, Ignacio Inglessis-Azuaje, J Am Coll Cardiol Intv. Sep 17, 2022. Epublished DOI: 10.1016/j.jcin.2022.09.005.
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