PRESERVE-MITRAL Post-Market Registry

Mitral Valve Disease Clinical Trial

Official title:

Prospective REgistry to Study Clinical OutcomEs of Repair of Mitral ValvEs in South Asia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03283722
• Other study ID #: MDT16016SUR002
• Status: Completed
• Start date: September 22, 2017
• Est. completion date: February 10, 2021

Study information

• Verified date: April 2022
• Source: Medtronic Cardiac Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this registry is to gather data on the clinical outcomes of Medtronic mitral repair products (Profile 3D™ and CG Future® annuloplasty systems) in the approved intended use up to 12 months from the day of procedure

Description:

There is limited local evidence on mitral repair products in South Asia and a prospective post market registry will provide real world data on clinical outcomes. Patients suffering from mitral valve disease and indicated for a mitral valve repair procedure with Profile 3D™ and CG Future® annuloplasty system as part of standard of care, in accordance with the product label indications (instructions for use), contraindications, and warnings will be considered for study participation. PRESERVE-Mitral Registry is a prospective non-randomized, non-interventional, post-market registry The objective of this registry is to gather data on the clinical outcomes of Medtronic mitral repair products (Profile 3D™ and CG Future® annuloplasty systems) in the approved intended use up to 12 months from the day of procedure

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 10, 2021
• Est. primary completion date: February 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. Patients with valvular insufficiency and/or stenosis and indicated for the reconstruction and/or remodeling of pathological mitral valves with Profile 3D™ and CG Future® annuloplasty systems

2. Indications and contraindications provided in the product Instructions for Use

3. Subject is 18 years of age or older

4. The patient or his/her Legally Authorized Representative (LAR) has been informed about the nature of the registry and the patient informed consent for study participation has been obtained prior to performing any study-related procedures from the subject or Legally Authorized Representative, as per applicable local requirements

Exclusion Criteria:

1. Contraindications as per instructions-for-use (IFU):

1. Heavily calcified valves

2. Valvular retraction with severely reduced mobility

3. Active bacterial endocarditis

2. Aortic valve replacement as concomitant procedure

3. Already participating in another clinical study, possibly leading to bias and jeopardizing the scientific appropriate assessment of the study endpoints

Related Conditions & MeSH terms

• Mitral Valve Disease

Intervention

Device:
• Profile 3D™ and CG Future® annuloplasty system
Patients suffering from mitral valve disease and indicated for a mitral valve repair procedure with Profile 3D™ and CG Future® annuloplasty system as part of standard of care, in accordance with the product label indications (instructions for use), contraindications, and warnings

Locations

Country	Name	City	State
Bangladesh	National Heart Foundation Hospital & Research Institute	Dhaka
India	EPIC Hospital	Ahmedabad	Gujarat
India	SAL Hospital & Medical Institute	Ahmedabad	Gujarat
India	U. N. Mehta Institute of Cardiology and Research Centre	Ahmedabad	Gujarat
India	Narayana Institute of Cardiac Sciences	Bangalore	Karnataka
India	Sri Jayadeva Institute of Cardiovascular Sciences & Research	Bangalore	Karnataka
India	The Madras Medical Mission	Chennai	Tamil Nadu
India	G. Kuppuswamy Memorial Hospital	Coimbatore	Tamil Nadu
India	CARE Hospitals	Hyderabad	Telangana
India	Amrita Institute of Medical Sciences and Research Center	Kochi	Kerala
India	P.D. Hinduja National Hospital and Medical Research Centre	Mumbai	Maharashtra
Nepal	Manmohan Cardiothoracic Vascular and Transplant Center	Kathmandu

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Surgery

Countries where clinical trial is conducted

Bangladesh,  India,  Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Mitral Regurgitation (MR) grade	Improvement in Mitral Regurgitation grade	12 months
Primary	All cause mortality	All deaths occurring from any cause post procedure	12 months
Secondary	Patient baseline and pathophysiology	Characterization of patient baseline demographics age, sex, height (cm), weight (kg) and pathophysiology of mitral valve disease	12 months
Secondary	Improvement in MR grade at discharge and first follow up		3-6 months
Secondary	Improvement in New York Heart Association (NYHA) functional class at discharge, first follow up (3-6 months) and second follow up (12 months) compared to baseline		At 7 days post procedure, 3-6 months & 12 months
Secondary	Hospitalization for Heart Failure at 6 months and at 12 months post procedure		6 months and 12 months post procedure
Secondary	Mitral valve re-intervention at discharge, 6 months and at 12 months post procedure		At 7 days post procedure, 6 months and 12 months post procedure
Secondary	Stroke at 6 months and at 12 months post procedure		6 months and 12 months post procedure
Secondary	New onset of Atrial Fibrillation at discharge, first follow up (3-6 months) and at second follow up (12 months)	As evaluated through follow up ECG	At 7 days post procedure, 3-6 months, 12 months
Secondary	Procedure details	Number of attempts required for procedural success, and bypass time as a measure of procedural complexity, as measured by standard operating room procedures at the site.	During the procedure