MARC details
000 -LEADER |
fixed length control field |
05167nam a22005537a 4500 |
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
fixed length control field |
230411s20232023 xxu||||| |||| 00| 0 eng d |
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
International Standard Serial Number |
2047-9980 |
024 ## - OTHER STANDARD IDENTIFIER |
Standard number or code |
10.1161/JAHA.122.027504 [doi] |
040 ## - CATALOGING SOURCE |
Original cataloging agency |
Ovid MEDLINE(R) |
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
PMID |
36752231 |
245 ## - TITLE STATEMENT |
Title |
Percutaneous MitraClip Device or Surgical Mitral Valve Repair in Patients With Primary Mitral Regurgitation Who Are Candidates for Surgery: Design and Rationale of the REPAIR MR Trial. |
251 ## - Source |
Source |
Journal of the American Heart Association. 12(4):e027504, 2023 Feb 21. |
252 ## - Abbreviated Source |
Abbreviated source |
J Am Heart Assoc. 12(4):e027504, 2023 Feb 21. |
253 ## - Journal Name |
Journal name |
Journal of the American Heart Association |
260 ## - PUBLICATION, DISTRIBUTION, ETC. |
Year |
2023 |
260 ## - PUBLICATION, DISTRIBUTION, ETC. |
Manufacturer |
FY2023 |
260 ## - PUBLICATION, DISTRIBUTION, ETC. |
Publication date |
2023 Feb 21 |
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
Publication status |
ppublish |
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
Medline status |
MEDLINE |
266 ## - Date added to catalog |
Date added to catalog |
2023-04-11 |
520 ## - SUMMARY, ETC. |
Abstract |
Background The current standard of care for the treatment of patients with primary mitral regurgitation (MR) is surgical mitral valve repair. Transcatheter edge-to-edge repair with the MitraClip device provides a less invasive treatment option for patients with both primary and secondary MR. Worldwide, >150 000 patients have been treated with the MitraClip device. However, in the United States, MitraClip is approved for use only in primary patients with MR who are at high or prohibitive risk for mitral valve surgery. The REPAIR MR (Percutaneous MitraClip Device or Surgical Mitral Valve Repair in Patients With Primary Mitral Regurgitation Who Are Candidates for Surgery) trial is designed to compare early and late outcomes associated with transcatheter edge-to-edge repair with the MitraClip and surgical repair of primary MR in older or moderate surgical risk patients. Methods and Results The REPAIR MR trial is a prospective, randomized, parallel-controlled, open-label multicenter, noninferiority trial for the treatment of severe primary MR (verified by an independent echocardiographic core laboratory). Patients with severe MR and indications for surgery because of symptoms (New York Heart Association class II-IV), or without symptoms with left ventricular ejection fraction <=60%, pulmonary artery systolic pressure >50 mm Hg, or left ventricular end-systolic diameter >=40 mm are eligible for the trial provided they meet the moderate surgical risk criteria as follows: (1) >=75 years of age, or (2) if <75 years of age, then the subject has a Society of Thoracic Surgeons Predicted Risk Of Mortality score of >=2% for mitral repair (or Society of Thoracic Surgeons replacement score of >=4%), or the presence of a comorbidity that may introduce a surgery-specific risk. The local surgeon must determine that the mitral valve can be surgically repaired. Additionally, an independent eligibility committee will confirm that the MR can be reduced to mild or less with both the MitraClip and surgical mitral valve repair with a high degree of certainty. A total of 500 eligible subjects will be randomized in a 1:1 ratio to receive the MitraClip device or to undergo surgical mitral valve repair (control group). There are 2 co-primary end points for the trial, both of which will be evaluated at 2 years. Each subject will be followed for 10 years after enrollment. The study has received approval from both the Food and Drug Administration and the Centers for Medicare and Medicaid Services, and enrolled its first subject in July 2020. Conclusions The REPAIR MR trial will determine the safety and effectiveness of transcatheter edge-to-edge repair with the MitraClip in patients with primary MR who are at moderate surgical risk and are candidates for surgical MV repair. The trial will generate contemporary comparative clinical evidence for the MitraClip device and surgical MV repair. Registration https://clinicaltrials.gov/ct2/show/NCT04198870; NCT04198870. |
546 ## - LANGUAGE NOTE |
Language note |
English |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Heart Valve Prosthesis Implantation |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Mitral Valve Insufficiency |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Aged |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Cardiac Catheterization/ae [Adverse Effects] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Heart Valve Prosthesis Implantation/mt [Methods] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Humans |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Medicare |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Mitral Valve Insufficiency/dg [Diagnostic Imaging] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Mitral Valve Insufficiency/et [Etiology] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Mitral Valve Insufficiency/su [Surgery] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Mitral Valve/dg [Diagnostic Imaging] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Mitral Valve/su [Surgery] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Prospective Studies |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Stroke Volume |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Treatment Outcome |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
United States |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Ventricular Function, Left |
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
Institution |
MedStar Health Research Institute |
657 ## - INDEX TERM--FUNCTION |
Medline publication type |
Journal Article |
657 ## - INDEX TERM--FUNCTION |
Medline publication type |
Multicenter Study |
657 ## - INDEX TERM--FUNCTION |
Medline publication type |
Randomized Controlled Trial |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Asch, Federico M |
Institution Code |
MHRI |
790 ## - Authors |
All authors |
McCarthy PM, Whisenant B, Asgar AW, Ailawadi G, Hermiller J, Williams M, Morse A, Rinaldi M, Grayburn P, Thomas JD, Martin R, Asch FM, Shu Y, Sundareswaran K, Moat N, Kar S |
856 ## - ELECTRONIC LOCATION AND ACCESS |
DOI |
<a href="https://dx.doi.org/10.1161/JAHA.122.027504">https://dx.doi.org/10.1161/JAHA.122.027504</a> |
Public note |
https://dx.doi.org/10.1161/JAHA.122.027504 |
858 ## - ORCID |
Orcid |
<a href="Asch, Federico M">Asch, Federico M</a> |
ORCID text |
https://orcid.org/0000-0002-1744-5271 |
Name |
Asch, Federico M |
942 ## - ADDED ENTRY ELEMENTS (KOHA) |
Koha item type |
Journal Article |
Item type description |
Article |