Clinical trial NCT03283722: PRESERVE-MITRAL Post-Market Registry
Official title: Prospective REgistry to Study Clinical OutcomEs of Repair of Mitral ValvEs in South Asia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Valve Disease
Lead sponsor: Medtronic Cardiac Surgery
Sponsor class: INDUSTRY
First posted: 2017-09-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.)

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in Mitral Regurgitation (MR) Grade at 12-months Post Procedure
timeFrame: 12 months
measure: All Cause Mortality
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of Participants With Improvement in MR Grade at Discharge and First Follow-up (3-6 Months)
timeFrame: At discharge from hospital (up to 7 days) and at first follow-up (3-6month)
measure: Improvement in NYHA Functional Class at Discharge, First Follow-up (3-6 Months) and Second Follow-up (12-months) Compared to Baseline.
timeFrame: At discharge from hospital (up to 7 days), at first follow-up (3-6months), and at the second follow-up (12 months)
measure: Hospitalization for Heart Failure at 6 Months and at 12 Months Post Procedure
timeFrame: 6 months and 12 months post procedure
measure: Mitral Valve Re-intervention at Discharge, 6 Months and at 12 Months Post Procedure
timeFrame: At discharge from hospital (up to 7 days), at first follow-up (3-6months), and at the second follow-up (12 months)
measure: Stroke at 6 Months and at 12 Months Post Procedure
timeFrame: 6 months and 12 months post procedure
measure: 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)
timeFrame: At discharge from hospital, (up to 7 days), at first follow-up (3-6month), and at the second follow-up (12 months)
measure: Number of Attempts Required for Procedural Success
timeFrame: 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)
measure: Total Bypass Time During the Implant Procedure
timeFrame: During the procedure as measured by standard operating procedures at the sites
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: National Heart Foundation Hospital & Research Institute
city: Ahmedabad
country: India
facility: U. N. Mehta Institute of Cardiology and Research Centre
state: Gujarat
city: Ahmedabad
country: India
facility: SAL Hospital & Medical Institute
state: Gujarat
city: Ahmedabad
country: India
facility: EPIC Hospital
state: Gujarat
city: Bangalore
country: India
facility: Sri Jayadeva Institute of Cardiovascular Sciences & Research
state: Karnataka
city: Bangalore
country: India
facility: Narayana Institute of Cardiac Sciences
state: Karnataka
city: Kochi
country: India
facility: Amrita Institute of Medical Sciences and Research Center
state: Kerala
city: Mumbai
country: India
facility: P.D. Hinduja National Hospital and Medical Research Centre
state: Maharashtra
city: Chennai
country: India
facility: The Madras Medical Mission
state: Tamil Nadu
city: Coimbatore
country: India
facility: G. Kuppuswamy Memorial Hospital
state: Tamil Nadu
city: Hyderabad
country: India
facility: CARE Hospitals
state: Telangana
city: Kathmandu
country: Nepal
facility: Manmohan Cardiothoracic Vascular and Transplant Center
Study officials:
affiliation: Medtronic
name: Vinay Rajan, Ph.D
role: STUDY_CHAIR
References: