PERIGON Japan Trial

A Multi-center, Non-randomized Trial to Determine the Safety and Effectiveness of the 17mm MDT-2215 Aortic Valve Bioprosthesis in Patients With Aortic Valve Disease

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

Study Overview

• Status: Completed
• Conditions: Aortic Stenosis
• Intervention / Treatment: Device: 17mm MDT-2215 aortic valve bioprosthesis

Detailed Description

This is a prospective, interventional, non-randomized, multi-center trial, with each site following a common protocol in Japan. A maximum of 20 subjects will be implanted at a maximum of 10 sites in Japan. The trial will include male and female patients of legal age to provide informed consent in Japan, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic valve. Patients will be followed and assessed after implant for up to 5 years.

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 trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CRF 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act of 42 CRF 11.24 and 11.44.)

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Chiba, Japan, 270-2251
    • Chiba-Nishi General Hospital
  • Hyogo Prefecture, Japan, 650-0017
    • Kobe University Hospital
  • Hyogo Prefecture, Japan, 670-8560
    • Hyogo Prefectural Harima-Himeji General Medical Center
  • Kyoto, Japan, 602-8566
    • University Hospital, Kyoto Prefectural University of Medicine
  • Okayama, Japan, 710-8602
    • Kurashiki Central Hospital
  • Osaka, Japan, 564-8565
    • National Cerebral and Cardiovascular Center
  • Saitama, Japan, 350-1298
    • Saitama Medical University International Medical Center
  • Saitama, Japan, 330-8503
    • Saitama Medical Center, Jichi Medical University
  • Tokushima, Japan, 773-8502
    • Tokushima Red Cross Hospital
  • Tokyo, Japan, 183-0003
    • Sakakibara Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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
2. Patient is geographically stable and willing to return to the implanting site for all follow-up visits
3. Patient is of legal age to provide informed consent
4. 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
5. In the opinion of the investigator, pre-operative imaging indicates the patient may be suitable for a 17mm size valve

Exclusion Criteria:

1. 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
2. Patient has had previous implant and then explant of the MDT-2215 aortic valve bioprosthesis
3. Patient presents with active endocarditis, active myocarditis or other systemic infection

4. 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)

5. 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
6. Patient has renal failure, defined as dialysis therapy or glomerular filtration rate (GFR)<30 mL/min/1.73 m2
7. Patient has hyperparathyroidism
8. Patient is participating in another investigational device or drug trial or observational competitive study
9. Patient is pregnant, lactating or planning to become pregnant
10. Patient has a documented history of substance (drug or alcohol) abuse
11. Patient has greater than mild mitral valve regurgitation or greater than mild tricuspid valve regurgitation as assessed by echocardiography
12. Patient has systolic ejection fraction (EF)<20% as assessed by echocardiography
13. Patient has grade IV diastolic dysfunction
14. Patient has documented bleeding diatheses
15. Patient has had an acute preoperative neurological deficit or myocardial infarction and has not returned to baseline or stabilized ≥30 days prior to enrollment
16. Patient requires emergency surgery
17. Patient is in NYHA Class I

18. Operative Exclusion Criteria:

    • 1.) Prior to attempted implant of MDT-2215 valve, it is identified the patient requires a concomitant procedure not allow per the enrollment exclusion criteria
    • 2.) Patient anatomy is not suitable for implant of a size 17mm MDT-2215 aortic valve bioprosthesis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MDT-2215; 17mm MDT-2215 aortic valve bioprosthesis	Device: 17mm MDT-2215 aortic valve bioprosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years	NYHA functional classification evaluation at baseline, discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. Measure Description: Cardiac Disease with Functional Classes 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 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	Effective orifice area index at baseline, discharge up to 30 days, 3-6 months, 1 year and annually thereafter through 5 years as measured by effective orifice area (cm^2) per unit body surface area (m^2). The achievement criterion for the effective orifice area index (EOAI) is defined to be ≥0.6 cm^2/m^2. 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 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 will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.	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 will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.	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 will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.	This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Degree of Paravalvular Regurgitation From Discharge up to 5 Years	This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.	This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Degree of Transvalvular Regurgitation From Discharge up to 5 Years	This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.	This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Degree of Total Valvular Regurgitation From Discharge up to 5 Years	This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.	This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Performance Index (L/Min) From Discharge up to 5 Years	This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.	This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Cardiac Output (L/Min) From Discharge up to 5 Years	This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.	This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Cardiac Index (L/Min/m^2) From Discharge up to 5 Years	This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.	This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Safety:Valve-related Adverse Events	The early (<=30days post-procedure), late (>30days post-procedure) and 1-year participant counts of the following valve-related adverse events will be evaluated: thromboembolism; thrombosis; hemorrhage; paravalvular leak; endocarditis; hemolysis; structural valve deterioration; non-structural dysfunction; reintervention; explant; death	This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
Quality of Life Assessment - Physical Component Summary (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality)	SF-36 Questionnaire Physical Component Summary (physical functioning, role-physical, bodily pain, general health, vitality) at baseline, 3-6 months, 1 year and annually thereafter through 5 years, where a higher score indicates a higher physical quality of life. Physical Component Summary Scale Lowest possible score: -7.28 Highest possible score: 52.71	This outcome will be evaluated at baseline, 3-6 months, 1 year and annually thereafter up to 5 years.
Quality of Life Assessment - Mental Component Summary (Social Functioning, Role-emotional, Mental Health)	SF-36 Questionnaire Mental Component Summary (social functioning, role-emotional, mental health) at baseline, 3-6 months, 1 year and annually thereafter through 5 years, where a higher score indicates a higher quality of mental life. Lowest possible score: 31.63 Highest possible score: 66.69	This outcome will be evaluated at baseline, 3-6 months, 1 year and annually thereafter up to 5 years.

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Surgery
• Collaborators: Medtronic
• Investigators: Principal Investigator: Yutaka Okita, MD, Kobe University Hospital, Japan

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): July 15, 2022

Study Registration Dates

• First Submitted: December 15, 2015
• First Submitted That Met QC Criteria: February 15, 2016
• First Posted (Estimated): February 22, 2016

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Valvular heart disease; Aortic valve replacement; Severe aortic stenosis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: MDT-2215