Randomized Controlled Trial

. 2022 Dec 26;15(24):2523-2536.

doi: 10.1016/j.jcin.2022.09.005. Epub 2022 Sep 17.

Randomized Comparison of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients

D Scott Lim¹, Robert L Smith², Linda D Gillam³, Firas Zahr⁴, Scott Chadderdon⁴, Raj Makkar⁵, Ralph Stephan von Bardeleben⁶, Robert M Kipperman³, Andrew N Rassi⁷, Molly Szerlip², Scott Goldman⁸, Ignacio Inglessis-Azuaje⁹, Pradeep Yadav¹⁰, Philipp Lurz¹¹, Charles J Davidson¹², Mubashir Mumtaz¹³, Hemal Gada¹³, Saibal Kar¹⁴, Susheel K Kodali¹⁵, Roger Laham¹⁶, William Hiesinger¹⁷, Neil P Fam¹⁸, Mirjam Keßler¹⁹, William W O'Neill²⁰, Brian Whisenant²¹, Chad Kliger²², Samir Kapadia²³, Volker Rudolph²⁴, Joseph Choo²⁵, James Hermiller²⁶, Michael A Morse²⁷, Niklas Schofer²⁸, Sameer Gafoor²⁹, Azeem Latib³⁰, Konstantinos Koulogiannis³, Leo Marcoff³, Jörg Hausleiter³¹; CLASP IID Pivotal Trial Investigators

Affiliations

¹ University of Virginia Health System Hospital, Charlottesville, Virginia, USA. Electronic address: sl9pc@virginia.edu.
² Baylor Scott and White: The Heart Hospital Plano, Plano, Texas, USA.
³ Atlantic Health System Morristown Medical Center, Morristown, New Jersey, USA.
⁴ Oregon Health & Science University, Portland, Oregon, USA.
⁵ Cedars-Sinai Medical Center, Los Angeles, California, USA.
⁶ University Medical Centre Mainz, Mainz, Germany.
⁷ Kaiser Permanente San Francisco Medical Center, San Francisco, California, USA.
⁸ Lankenau Medical Center, Wynnewood, Pennsylvania, USA.
⁹ Massachusetts General Hospital, Boston, Massachusetts, USA.
¹⁰ Piedmont Heart Institute, Atlanta, Georgia, USA.
¹¹ University of Leipzig, Leipzig, Germany.
¹² Northwestern University, Chicago, Illinois, USA.
¹³ UPMC Pinnacle, Harrisburg, Pennsylvania, USA.
¹⁴ Los Robles Regional Medical Center, Thousand Oaks, California, USA.
¹⁵ Columbia University Medical Center, New York, New York, USA.
¹⁶ Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
¹⁷ Stanford University Medical Center, Palo Alto, California, USA.
¹⁸ St. Michael's Hospital, Toronto, Ontario, Canada.
¹⁹ University of Ulm, Ulm, Germany.
²⁰ Henry Ford Hospital, Detroit, Michigan, USA.
²¹ Intermountain Medical Center, Salt Lake City, Utah, USA.
²² Northwell-Lenox Hill, New York, New York, USA.
²³ Cleveland Clinic Foundation, Cleveland, Ohio, USA.
²⁴ Ruhr-Universität Bochum, Bochum, Bad Oeynhausen, Germany.
²⁵ The Christ Hospital, Cincinnati, Ohio, USA.
²⁶ St. Vincent Heart Center of Indiana, Indianapolis, Indiana, USA.
²⁷ Ascension Saint Thomas Hospital, Nashville, Tennessee, USA.
²⁸ University Heart and Vascular Center Hamburg, Hamburg, Germany.
²⁹ Swedish Medical Center, Seattle, Washington, USA.
³⁰ Montefiore Medical Center, Bronx, New York, USA.
³¹ Klinikum der Universität München, Munich, Germany.

PMID: 36121247
DOI: 10.1016/j.jcin.2022.09.005

Free article

Randomized Controlled Trial

Randomized Comparison of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients

D Scott Lim et al. JACC Cardiovasc Interv. 2022.

Free article

. 2022 Dec 26;15(24):2523-2536.

doi: 10.1016/j.jcin.2022.09.005. Epub 2022 Sep 17.

Authors

Affiliations

¹ University of Virginia Health System Hospital, Charlottesville, Virginia, USA. Electronic address: sl9pc@virginia.edu.
² Baylor Scott and White: The Heart Hospital Plano, Plano, Texas, USA.
³ Atlantic Health System Morristown Medical Center, Morristown, New Jersey, USA.
⁴ Oregon Health & Science University, Portland, Oregon, USA.
⁵ Cedars-Sinai Medical Center, Los Angeles, California, USA.
⁶ University Medical Centre Mainz, Mainz, Germany.
⁷ Kaiser Permanente San Francisco Medical Center, San Francisco, California, USA.
⁸ Lankenau Medical Center, Wynnewood, Pennsylvania, USA.
⁹ Massachusetts General Hospital, Boston, Massachusetts, USA.
¹⁰ Piedmont Heart Institute, Atlanta, Georgia, USA.
¹¹ University of Leipzig, Leipzig, Germany.
¹² Northwestern University, Chicago, Illinois, USA.
¹³ UPMC Pinnacle, Harrisburg, Pennsylvania, USA.
¹⁴ Los Robles Regional Medical Center, Thousand Oaks, California, USA.
¹⁵ Columbia University Medical Center, New York, New York, USA.
¹⁶ Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
¹⁷ Stanford University Medical Center, Palo Alto, California, USA.
¹⁸ St. Michael's Hospital, Toronto, Ontario, Canada.
¹⁹ University of Ulm, Ulm, Germany.
²⁰ Henry Ford Hospital, Detroit, Michigan, USA.
²¹ Intermountain Medical Center, Salt Lake City, Utah, USA.
²² Northwell-Lenox Hill, New York, New York, USA.
²³ Cleveland Clinic Foundation, Cleveland, Ohio, USA.
²⁴ Ruhr-Universität Bochum, Bochum, Bad Oeynhausen, Germany.
²⁵ The Christ Hospital, Cincinnati, Ohio, USA.
²⁶ St. Vincent Heart Center of Indiana, Indianapolis, Indiana, USA.
²⁷ Ascension Saint Thomas Hospital, Nashville, Tennessee, USA.
²⁸ University Heart and Vascular Center Hamburg, Hamburg, Germany.
²⁹ Swedish Medical Center, Seattle, Washington, USA.
³⁰ Montefiore Medical Center, Bronx, New York, USA.
³¹ Klinikum der Universität München, Munich, Germany.

PMID: 36121247
DOI: 10.1016/j.jcin.2022.09.005

Abstract

Background: Severe symptomatic degenerative mitral regurgitation (DMR) has a poor prognosis in the absence of treatment, and new transcatheter options are emerging.

Objectives: The CLASP IID (Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial) randomized trial (NCT03706833) is the first to evaluate the safety and effectiveness of the PASCAL system compared with the MitraClip system in patients with significant symptomatic DMR. This report presents the primary safety and effectiveness endpoints for the trial.

Methods: Patients with 3+ or 4+ DMR at prohibitive surgical risk were assessed by a central screening committee and randomized 2:1 (PASCAL:MitraClip). Study oversight also included an echocardiography core laboratory and a clinical events committee. The primary safety endpoint was the composite major adverse event rate at 30 days. The primary effectiveness endpoint was the proportion of patients with mitral regurgitation (MR) ≤2+ at 6 months.

Results: A prespecified interim analysis in 180 patients demonstrated noninferiority of the PASCAL system vs the MitraClip system for the primary safety and effectiveness endpoints of major adverse event rate (3.4% vs 4.8%) and MR ≤2+ (96.5% vs 96.8%), respectively. Functional and quality-of-life outcomes significantly improved in both groups (P < 0.05). The proportion of patients with MR ≤1+ was durable in the PASCAL group from discharge to 6 months (PASCAL, 87.2% and 83.7% [P = 0.317 vs discharge]; MitraClip, 88.5% and 71.2% [P = 0.003 vs discharge]).

Conclusions: The CLASP IID trial demonstrated safety and effectiveness of the PASCAL system and met noninferiority endpoints, expanding transcatheter treatment options for prohibitive surgical risk patients with significant symptomatic DMR.

Keywords: CLASP IID; M-TEER; MitraClip system; PASCAL system; TMVr; mitral valve transcatheter edge-to-edge repair; transcatheter mitral valve repair.

PubMed Disclaimer

Conflict of interest statement

Funding Support and Author Disclosures The CLASP IID trial is funded by Edwards Lifesciences. Dr Lim is a consultant for Philips, Venus, and Valgen; and has received research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Smith is on the CLASP IID trial leadership team; has received institutional grant and travel support for device evaluation from Edwards Lifesciences; has received institutional grants from Artivion; and has received speaker honoraria from Artivion and Medtronic. Dr Gillam is a consultant for Philips, Bracco, and Edwards Lifesciences; and directs an echocardiography core laboratory for Abbott, Edwards Lifesciences, and Medtronic for which she has received no direct compensation. Dr Zahr is a consultant for and has received research and educational grants from Edwards Lifesciences. Dr Chadderdon is an educational consultant for Edwards Lifesciences and Medtronic. Dr Makkar is a consultant for and has received research grants from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific. Dr von Bardeleben is a principal investigator for phase 3, postmarket clinical trials and investigator-initiated trials (Reshape II HF, TENDER, EuroSMR, and other registries) for Abbott, Daiichi-Sankyo, Edwards Lifesciences, Medtronic, NeoChord, Philips, and Siemens. Dr Szerlip is a proctor and speaker for Edwards Lifesciences; serves as a national principal investigator for an early feasibility study; is on the advisory board and serves as a proctor for Abbott; is part of the steering committee for Medtronic; and is a speaker for Boston Scientific. Dr Goldman is involved in minimally invasive mitral valve observation for Edwards Lifesciences. Dr Inglessis-Azuaje is a proctor and serves as a lecturer for Edwards Lifesciences; is a consultant and proctor for Medtronic; and is a lecturer for Boston Scientific. Dr Yadav is a consultant and speaker for Edwards Lifesciences, Abbott, Dasi Simulations, and Shockwave Medical. Dr Lurz has received institutional grants from Edwards Lifesciences, Abbott, and ReCor. Dr Davidson is a consultant for and has received research grant support from Edwards Lifesciences. Dr Mumtaz is a consultant and proctor for and has received honoraria and research support from Edwards Lifesciences, Abbott, Medtronic, JOMDD, Teleflex, and Atricure. Dr Gada is a consultant for Medtronic, Boston Scientific, Abbott, and Becton Dickinson. Dr Kar is a consultant for Abbott, Medtronic, Boston Scientific, W.L. Gore, Laminar, Intershunt, and V-Wave; has received institutional research grants from Abbott, Medtronic, Boston Scientific, Edwards Lifesciences, and Highlife; is the co–national principal investigator for the REPAIR MR trial and EXPAND registry and co–national principal investigator for the PINNACLE FLX trial and CHAMPION trial; and serves on the steering committee for the Triluminate trial and is an executive committee member for the RELIEVE HF trial. Dr Kodali is a consultant for and has received honoraria from Admedus, Dura Biotech, TriCares, Phillips and TriFlo; has received institutional research funding from Edwards Lifesciences, Medtronic, Abbott, Boston Scientific and JenaValve; serves on the scientific advisory board for and has received equity from Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve, Supira, Admedus, TriFlo, Adona, Tioga, and X-Dot. Dr Laham is a speaker for and has received compensation from Abbott, Edwards Lifesciences, and Medtronic. Dr Fam is a consultant for Edwards Lifesciences and Abbott. Dr Keßler has received speaker honoraria from Edwards Lifesciences and Abbott. Dr O’Neill is a consultant for Abiomed, Boston Scientific, and Abbott; and was previously a consultant (expired) for Edwards Lifesciences. Dr Whisenant is a consultant for Edwards Lifesciences and Abbott. Dr Kliger is a consultant for and has received speaker honoraria from Edwards Lifesciences, Medtronic, and Siemens. Dr Rudolph has received research grants from Edwards Lifesciences, Abbott, and Boston Scientific. Dr Hermiller is a consultant and proctor for Edwards Lifesciences. Dr Morse is a consultant for Edwards Lifesciences. Dr Schofer has received travel support from Edwards Lifesciences and Abbott/St. Jude Medical; and has received speaker honoraria from Edwards Lifesciences and Boston Scientific. Dr Latib is a consultant and serves on advisory boards for Boston Scientific, Edwards Lifesciences, Medtronic, Abbott, and Philips. Dr Koulogiannis is a consultant and advisory board member for Edwards Lifesciences; and is a speaker for Abbott. Dr Marcoff serves as a member of the echocardiography core laboratory for Edwards Lifesciences and Abbott, for which he has received no direct compensation. Dr Hausleiter is a consultant for and has received speaker honoraria and institutional research support from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Comment in

Mitral Transcatheter Edge-to-Edge Repair: A Choice!
Webb JG, Boone RH. Webb JG, et al. JACC Cardiovasc Interv. 2022 Dec 26;15(24):2537-2540. doi: 10.1016/j.jcin.2022.10.005. JACC Cardiovasc Interv. 2022. PMID: 36543447 No abstract available.

Publication types

Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Associated data

Actions
- Search in PubMed
- Search in ClinicalTrials.gov

LinkOut - more resources

Full Text Sources
- ClinicalKey
- Elsevier Science
Medical
- ClinicalTrials.gov
Miscellaneous
- NCI CPTAC Assay Portal

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Randomized Comparison of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients

Affiliations

Randomized Comparison of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients

Authors

Affiliations

Abstract

Conflict of interest statement

Comment in

Publication types

MeSH terms

Associated data

LinkOut - more resources

Full Text Sources

Medical

Miscellaneous