PRESERVE-MITRAL Post-Market Registry

Completed

Conditions: Mitral Valve Disease

Registration Number: NCT03283722

Lead Sponsor: Medtronic Cardiac Surgery

Brief 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

Detailed 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

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trail was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Heath Service Act or 42 CRF 11.24 and 11.44.)

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 200

Inclusion Criteria

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
Indications and contraindications provided in the product Instructions for Use
Subject is 18 years of age or older
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

Contraindications as per instructions-for-use (IFU):
1. Heavily calcified valves
2. Valvular retraction with severely reduced mobility
3. Active bacterial endocarditis
Aortic valve replacement as concomitant procedure
Already participating in another clinical study, possibly leading to bias and jeopardizing the scientific appropriate assessment of the study endpoints

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All Cause Mortality	12 months	All deaths occurring from any cause 12-months post procedure
Improvement in Mitral Regurgitation (MR) Grade at 12-months Post Procedure	12 months	This is determined by assessing the level of mitral valve regurgitation using echo, in subjects at 12-months post-procedure compared to the level at baseline. The levels of regurgitation, level 0-4, correspond to the American Society of Echocardiography (ASE) guidelines ranging from no MR, Mild MR, Moderate MR, Moderate- to-Severe MR and Severe MR. A percentage number is calculated to reflect how many participants had an MR improvement.

Secondary Outcome Measures

Name	Time	Method
Total Bypass Time During the Implant Procedure	During the procedure as measured by standard operating procedures at the sites	Total time a subject is on bypass time as a measure of procedural complexity
Hospitalization for Heart Failure at 6 Months and at 12 Months Post Procedure	6 months and 12 months post procedure	Subjects who have a non-elective hospital admission for signs and symptoms related to heart failure that results in a one night stay (i.e., where the admission date and the discharge date differ by at least one calendar day)
Improvement in NYHA Functional Class at Discharge, First Follow-up (3-6 Months) and Second Follow-up (12-months) Compared to Baseline.	At discharge from hospital (up to 7 days), at first follow-up (3-6months), and at the second follow-up (12 months)	The percentage of subjects with an improved New York Heart Association NYHA functional class using a two-sided 95% exact binomial confidence internal measured at discharge, 3-6 months, and 12-months post-procedure and compared to baseline.
Stroke at 6 Months and at 12 Months Post Procedure	6 months and 12 months post procedure	Subjects had an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction, where the neurological dysfunction lasts for greater than 24-hours
Number of Attempts Required for Procedural Success	Procedure (defined as the date of the first attempted procedure through subject leaving the operating theater with an implanted Profile 3D or CG Future annuloplasty system)	Number of surgical attempts required for procedural implant success
Percentage of Participants With Improvement in MR Grade at Discharge and First Follow-up (3-6 Months)	At discharge from hospital (up to 7 days) and at first follow-up (3-6month)	This was determined by assessing the level of mitral valve regurgitation using hemodynamic performance, in subjects at discharge and 3-6 months post-procedure compared to the level at baseline. The levels of regurgitation, level 0-4, correspond to the ASE guidelines ranging from no MR, Mild MR, Moderate MR, Moderate-to-Severe MR and Severe MR
Mitral Valve Re-intervention at Discharge, 6 Months and at 12 Months Post Procedure	At discharge from hospital (up to 7 days), at first follow-up (3-6months), and at the second follow-up (12 months)	Subject leaving the operating theater with an implanted Profile 3DTM or CG Future® annuloplasty system and later undergo any surgical or percutaneous interventional catheter procedure that repairs, otherwise alters or adjusts, or replaces the previously implanted annuloplasty system is considered a reoperation
New Onset of Atrial Fibrillation, as Evaluated Through Follow up ECG at Discharge, First Follow up (3-6months) and at Second Follow up (12 Months)	At discharge from hospital, (up to 7 days), at first follow-up (3-6month), and at the second follow-up (12 months)	New onset of AF is defined as when the subject did not present with prior history of AF at baseline nor was AF detected at baseline visit, but AF did manifest post procedure and was either diagnosed during the study visits (discharge, 3-6 months or 12 months visit) or was otherwise diagnosed during the duration of subject participation in the study. The incidence of new onset AF will be evaluated at discharge, first follow up (3-6 months) and at second follow up (12 months). This endpoint is analyzed for the Successfully Implanted (IMP) cohort and provided as a Kaplan-Meier analysis.

Trial Locations

Locations (12): EPIC Hospital
🇮🇳
Ahmedabad, Gujarat, India
The Madras Medical Mission
🇮🇳
Chennai, Tamil Nadu, India
Amrita Institute of Medical Sciences and Research Center
🇮🇳
Kochi, Kerala, India
U. N. Mehta Institute of Cardiology and Research Centre
🇮🇳
Ahmedabad, Gujarat, India
Manmohan Cardiothoracic Vascular and Transplant Center
🇳🇵
Kathmandu, Nepal
G. Kuppuswamy Memorial Hospital
🇮🇳
Coimbatore, Tamil Nadu, India
Narayana Institute of Cardiac Sciences
🇮🇳
Bangalore, Karnataka, India
SAL Hospital & Medical Institute
🇮🇳
Ahmedabad, Gujarat, India
National Heart Foundation Hospital & Research Institute
🇧🇩
Dhaka, Bangladesh
P.D. Hinduja National Hospital and Medical Research Centre
🇮🇳
Mumbai, Maharashtra, India
Sri Jayadeva Institute of Cardiovascular Sciences & Research
🇮🇳
Bangalore, Karnataka, India
CARE Hospitals
🇮🇳
Hyderabad, Telangana, India