Study on Safety and Performance of Medtentia Mitral Valve Repair System in Surgical Repair of Mitral Regurgitation

Not Applicable

Terminated

Conditions: Mitral Regurgitation
Mitral Insufficiency

Interventions: Device: Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)

Registration Number: NCT01678144

Lead Sponsor: Medtentia International Ltd Oy

Brief Summary: The purpose of the trial is to demonstrate the safety and performance of the Medtentia Annuloplasty Ring (MAR) during mitral valve repair surgery. In addition, the trial aims to demonstrate that the MAR fulfills the requirements for mitral valve annuloplasty rings.

Detailed Description: The purpose of this study is to evaluate the safety and performance of the MAR in patients with mitral regurgitation requiring either isolated mitral valve annuloplasty or mitral valve annuloplasty concomitantly with any of the following, either individually or in combination:

* Tricuspid valve repair

* Coronary artery bypass grafting (CABG)

* Valve resection and chordae repair

* Correction of atrial septal defect

* Correction of patent foramen ovale

* Ablation therapy for atrial defibrillation

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Medtentia Annuloplasty Ring (MAR)	Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)	All eligible patients underwent surgical mitral valve repair using annuloplasty device - Medtentia Annuloplasty Ring (MAR)

Primary Outcome Measures

Name	Time	Method
Safety: All-cause Mortality Occurring in the Time From Surgery Through Hospital Discharge.	Time from surgery through hospital discharge, up to 7 days.
Performance: Percentage of Participants With Improvement by at Least 2 Mitral Regurgitation Classes From Baseline (SC) to Three Months (V03) as Measured by Trans-thoracic Echocardiography (TTE).	Time from baseline through V03 (3 months)	Success will be defined as an improvement in at least 2 degrees in mitral regurgitation (MR) class as described in the ACC/AHA Guidelines for the Management of Patients with Valvular Heart Disease (Bonow, et al., 2008).

Secondary Outcome Measures

Name	Time	Method
Safety: The Occurrence, Nature and Frequency of Treatment-emergent Adverse Events (AEs), in Particular Severe Serious Adverse Device Effects (SADEs).	From surgery to end of study (2 years).	All the adverse events reported were non-device related.
Safety: 30-day Mortality and Mortality at 3 Months, 6 Months, 1 Year, 1.5 Years and 2 Years.	30 days, 3 months, 6 months, 1 year, 1.5 years and 2 years after surgery	Mortality rates determined both for all-cause mortality and for related deaths only. For the former, the causality status will be determined by the Investigator, and all deaths that are clearly unrelated to the device, the surgery or the underlying medical condition will be excluded from the analysis.
Safety: The Occurrence, Frequency and Timing of Treatment-emergent Major Adverse Cardiac Events (MACEs).	From surgery to end of study (2 years)	MACE is defined as stroke and clinically significant myocardial infarction (MI), from surgery to end of study.
Safety: The Occurrence, Nature and Frequency of Device Deficiencies and Adverse Device Effects (ADEs).	From surgery to end of study (2 years).
Safety: The Occurrence, Frequency and Nature of Abnormalities in the Period From Surgery Through Follow-up (Detailed List in Description Field).	From surgery to end of study (2 years).	The occurrence, frequency and nature of abnormalities in any of the following: * physical examination * vital signs * electrocardiography (ECG) * echocardiography (ECHO) * Laboratory tests * Chest X-rays (taken only when clinically indicated)
Performance: Mitral Regurgitation (MR) as Seen in Trans-esophageal Echocardiography (TEE) Performed During Surgery Before and After Annuloplasty.	Day of surgery visit (V01).	Success will be defined as no or only residual mitral regurgitation (MR).
Performance: Percentage of Participants With Improvement by at Least 2 Mitral Regurgitation Classes at Each Follow-up Visit (V04-V06) of the Improvement in MR From Screening, as Measured by Trans-thoracic Echocardiography (TTE).	V06 (24 months)	Measurement analysis at 24 months after successful MAR implantation.