PERIGON Japan Trial

NCT02686814 | Completed Results DMC

• 1 other identifier: MDT-2215
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the 17mm MDT-2215 aortic valve bioprosthesis.

Conditions

Aortic Stenosis

Keywords

Valvular heart disease; Severe aortic stenosis; Aortic valve replacement

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Changes in NYHA Classification From Baseline to 1 Year Post-procedure

  Change in New York Heart Association (NYHA) functional classification from baseline to 1 year post-procedure will be evaluated. Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort.

  This outcome will be identified from measurement at baseline and 1 year.

• Effective Orifice Area Index at Baseline and 1 Year Post-procedure

  Effective Orifice Area Index (EOAI) at 1 year post-procedure will be evaluated. Effective Orifice Area Index (EOAI) in cm\^2/m\^2 EOAI = EOA/BSA Where: EOA is the effective orifice area in cm\^2, and BSA is the body surface area in m\^2

  This outcome will be measured at 1 year.

• Number of Participants With Composite New York Heart Association (NYHA) Classification and Effective Orifice EOAI Endpoint Improvement From Baseline to 1 Year

  Composite number of participants with NYHA change from baseline to 1 year post-procedure of 1 or greater and effective number of participants with effective EOAI 0.6cm\^2/m\^2 or greater at 1 year post implant will be evaluated. The objective is met if at least 60% of the subjects achieve the specified improvement in NYHA and EOAI. See Objective 1 for NYHA definition See Objective 2 for EOAI definition

  This outcome will be identified from measurement at baseline and 1 year.

Secondary Outcomes (14)

• Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years

  This outcome will be evaluated at baseline, discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.

• Mean Effective Orifice Area Index (cm^2/m^2) From Baseline up to 5 Years

  This outcome will be evaluated at baseline, discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.

• Effective Orifice Area (cm^2) From Baseline up to 5 Years

  This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.

• Peak Pressure Gradient (mmHg) From Discharge up to 5 Years

  This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.

• Mean Pressure Gradient (mmHg) From Discharge up to 5 Years

  This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.

Study Arms (1)

MDT-2215

EXPERIMENTAL

17mm MDT-2215 aortic valve bioprosthesis

Device: 17mm MDT-2215 aortic valve bioprosthesis

Interventions

17mm MDT-2215 aortic valve bioprosthesis DEVICE

MDT-2215

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has severe aortic stenosis or regurgitation, and there is clinical indication for replacement of their native or prosthetic aortic valve with a bioprosthesis, with or without concomitant procedures, which are limited to any of the following:
• Left atrial appendage (LAA) ligation
• Coronary artery bypass graft (CABG)
• Patent foramen ovale (PFO) closure
• Ascending aortic aneurysm or dissection repair not requiring circulatory arrest
• Resection of a sub-aortic membrane not requiring myectomy
• Patient is geographically stable and willing to return to the implanting site for all follow-up visits
• Patient is of legal age to provide informed consent
• Patient has been adequately informed of risks and requirements of the trial and is willing and able to provide informed consent for participation in the clinical trial
• In the opinion of the investigator, pre-operative imaging indicates the patient may be suitable for a 17mm size valve

You may not qualify if:

• Patient has a pre-existing prosthetic valve or annuloplasty device in another position or requires replacement or repair of the mitral, pulmonary or tricuspid valve
• Patient has had previous implant and then explant of the MDT-2215 aortic valve bioprosthesis
• Patient presents with active endocarditis, active myocarditis or other systemic infection
• Patient has an anatomical abnormality which would increase surgical risk of morbidity or mortality, including:
• Ascending aortic aneurysm or dissection repair requiring circulatory arrest
• Acute type A aortic dissection
• Ventricular aneurysm
• Porcelain aorta
• Hostile mediastinum
• Hypertrophic obstructive cardiomyopathy (HOCM)
• Documented pulmonary hypertension (systolic \>60mmHg)
• Patient has a non-cardiac major or progressive disease, with a life expectancy of less than 2 years. These conditions include, but are not limited to:
• Child-Pugh Class C liver disease
• Terminal cancer
• End-stage lung disease

Sponsors & Collaborators

• Medtronic Cardiac Surgery: lead
• Medtronic: collaborator

Study Sites (10)

Chiba-Nishi General Hospital

Chiba, 270-2251, Japan

Location

Kobe University Hospital

Hyogo Prefecture, 650-0017, Japan

Location

Hyogo Prefectural Harima-Himeji General Medical Center

Hyogo Prefecture, 670-8560, Japan

Location

University Hospital, Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

Location

Kurashiki Central Hospital

Okayama, 710-8602, Japan

Location

National Cerebral and Cardiovascular Center

Osaka, 564-8565, Japan

Location

Saitama Medical Center, Jichi Medical University

Saitama, 330-8503, Japan

Location

Saitama Medical University International Medical Center

Saitama, 350-1298, Japan

Location

Tokushima Red Cross Hospital

Tokushima, 773-8502, Japan

Location

Sakakibara Heart Institute

Tokyo, 183-0003, Japan

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Limitations and Caveats

Every effort was undertaken to minimize missing data. Unless otherwise specified in each objective, no statistical techniques were used to impute missing data for continuous or categorical outcomes. If a subject's data were missing for any reason, that subject was not included in that portion of the analysis. The number of subjects included in each analysis was reported so that the reader can assess the potential impact of missing data.

Results Point of Contact

• Title: Jessica Halverson, Clinical Research Director
• Organization: Medtronic

rs.perigonjapantrial@medtronic.com

(800) 633-8766

Study Officials

• Yutaka Okita, MD

  Kobe University Hospital, Japan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: February 22, 2016
• Study Start: March 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: July 15, 2022
• Last Updated: April 12, 2024
• Results First Posted: April 12, 2024

Record last verified: 2023-10

Locations

JP (10)