Ignite Creation Date:
2024-05-06 @ 4:29 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05002543
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2021-07-26
Brief Title:
CORCYM Mitral Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting
Sponsor:
Corcym Srl
Organization:
Corcym Srl
Study Overview
Official Title:
CORCYM Mitral Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MANTRA
Brief 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 Srl 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 - MitralTricuspid Sub-Study Excluding Memo 4D
MANTRA - Memo 4D Sub-Study
Corcym Srl 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 - MitralTricuspid Sub-Study Excluding Memo 4D
MANTRA - Memo 4D Sub-Study
Detailed Description:
The MANTRA Master Plan Master Protocol is intended as an overarching Umbrella Protocol that allows multiple substudies 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
Currently three substudies are planned
MANTRA - Aortic Sub-Study
MANTRA - MitralTricuspid Sub-Study excluding Memo 4D
MANTRA - Memo 4D Sub-Study
The aim of the studies assembled under the master protocol is the continued collection of safety and performance data during heart valve procedures and the relevant follow-up visits in subjects where any of the CORCYM devices and accessories are used in a real-world setting in accordance with the IFUs and at the discretion of the investigator
MANTRA study is expected to enroll approximately 2150 subjects in up to 130 sites worldwide
Approximately 1650 subjects considered suitable for treatment with a CORCYM aortic device
Approximately 300 subjects considered suitable for treatment with a CORCYM mitral andor tricuspid device excluding Memo 4D
Approximately 200 subjects considered suitable for treatment with Memo 4D
Expected enrollment duration may vary across the different projects Subject follow-up is planned at discharge 30 days after implantation and then annually up to 10 years Sites can choose to participate in one or more sub-studies
All available data shall be gathered during standard medical care
At a minimum the following data will be collected
Informed Consent
ScreeningBaseline data including demographics and medical history
Procedural data
Hospitalization and Discharge data
Follow-up data 30 days and annually up to 10 years post procedure
Serious Adverse Event and Device Deficiencies information
As part of the study the subject will be asked to complete quality of life questionnaires at baseline 30 days and at 1-year follow-up
In addition for the MEMO 4D sub-study only an Echocardiography Core Laboratory has been appointed by the Sponsor to assess the hemodynamic and structural performance annular motion and dynamics and 3D echocardiogram images transesophageal during the procedure and transthoracic during follow up will be collected for Corelab readings
Currently three substudies are planned
MANTRA - Aortic Sub-Study
MANTRA - MitralTricuspid Sub-Study excluding Memo 4D
MANTRA - Memo 4D Sub-Study
The aim of the studies assembled under the master protocol is the continued collection of safety and performance data during heart valve procedures and the relevant follow-up visits in subjects where any of the CORCYM devices and accessories are used in a real-world setting in accordance with the IFUs and at the discretion of the investigator
MANTRA study is expected to enroll approximately 2150 subjects in up to 130 sites worldwide
Approximately 1650 subjects considered suitable for treatment with a CORCYM aortic device
Approximately 300 subjects considered suitable for treatment with a CORCYM mitral andor tricuspid device excluding Memo 4D
Approximately 200 subjects considered suitable for treatment with Memo 4D
Expected enrollment duration may vary across the different projects Subject follow-up is planned at discharge 30 days after implantation and then annually up to 10 years Sites can choose to participate in one or more sub-studies
All available data shall be gathered during standard medical care
At a minimum the following data will be collected
Informed Consent
ScreeningBaseline data including demographics and medical history
Procedural data
Hospitalization and Discharge data
Follow-up data 30 days and annually up to 10 years post procedure
Serious Adverse Event and Device Deficiencies information
As part of the study the subject will be asked to complete quality of life questionnaires at baseline 30 days and at 1-year follow-up
In addition for the MEMO 4D sub-study only an Echocardiography Core Laboratory has been appointed by the Sponsor to assess the hemodynamic and structural performance annular motion and dynamics and 3D echocardiogram images transesophageal during the procedure and transthoracic during follow up will be collected for Corelab readings
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None