CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting

Condition(s) studied

Study summary

MANTRA is a prospective, multiple-arm, multi-center, global, post-market clinical follow-up study. The main objective is to monitor ongoing safety and performance of the CORCYM devices and accessories used for aortic, mitral and tricuspid valvular diseases in a real-world setting.

Corcym S.r.l., is a medical device manufacturer with a broad product portfolio for cardiac surgeons, offering solutions for the treatment of aortic, mitral and tricuspid valve disease.

The MANTRA Master Plan (Master Protocol) is intended as an overarching Umbrella Protocol that allows multiple sub-studies to be added, as needed. The Umbrella Master Protocol concept offers an excellent solution to provide post-marketing clinical follow-up information on the entire cardiac surgery heart valve portfolio of the sponsor in a common database, including corelab assessment of hemodynamic and structural performance, annular motion and Dynamics for one of the products.

Currently, three sub-studies are planned:

* MANTRA - Aortic Sub-Study
* MANTRA - Mitral/Tricuspid Sub-Study (Excluding Memo 4D)
* MANTRA - Memo 4D Sub-Study

Eligibility

Primary outcome measure(s)

• The primary endpoint in the AORTIC Sub-study is number and percentage of subjects with Device Success — 30 days
  Device success at 30 days (+14 days) based on VARC-3, defined as: * Technical success * Freedom from mortality * Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication * Intended performance of the valve (mean gradient\<20 mmHg and less than moderate aortic regurgitation) The number and percentage of subjects with device success at 30 days as per VARC-3 definition, along with individual component of the success, will be presented.
• The primary endpoint in the MITRAL/TRICUSPID Sub-study is number and percentage of subjects with Device Success — 30 days
  Device success at 30 days (+14 days) based on MVARC, defined as: * Procedural mortality or stroke AND * Proper placement and positioning of the device AND * Freedom from unplanned surgical or interventional procedures related to the device or access procedure AND * Continued intended safety and performance of the device, including: * Evidence of structural or functional failure * Specific device-related technical failure issues and complications * MITRAL: Reduction of Mitral Regurgitation (MR) to either optimal or acceptable levels (site-reported) * TRICUSPID: Reduction of Tricuspid Regurgitation (TR) to either optimal or acceptable levels (site-reported) Number and percentage of subjects with device success, along with individual component, will be presented.
• The primary endpoint in the MEMO 4D Sub-study is number and percentage of subjects with Device Success — 30 days
  Device success at 30 days (+14 days) based on the MVARC, defined as: * Procedural mortality or stroke; AND * Proper placement and positioning of the device; AND * Freedom from unplanned surgical or interventional procedures related to the device or access procedure; AND * Continued intended safety and performance of the device, including: * Evidence of structural or functional failure * Specific device-related technical failure issues and complications * Reduction of Mitral Regurgitation (MR) to either optimal or acceptable levels without significant mitral stenosis (i.e., post-procedure EOA is ≥ 1.5 cm2 with a transmitral gradient \<5 mmHg), and with no greater than mild MR core-lab assessed The number and percentage of subjects with device success at 30 days as per MVARC definition, along with individual component of the success, will be presented.

Trial sites (52)

+ 12 more sites — see the full list on the official registry below.