PERIGON Japan Trial

Aortic Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02686814
• Other study ID #: MDT-2215
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: July 15, 2022

Study information

• Verified date: October 2023
• Source: Medtronic Cardiac Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 15, 2022
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis

Intervention

Device:
• 17mm MDT-2215 aortic valve bioprosthesis

Locations

Country	Name	City	State
Japan	Chiba-Nishi General Hospital	Chiba
Japan	Hyogo Prefectural Harima-Himeji General Medical Center	Hyogo Prefecture
Japan	Kobe University Hospital	Hyogo Prefecture
Japan	University Hospital, Kyoto Prefectural University of Medicine	Kyoto
Japan	Kurashiki Central Hospital	Okayama
Japan	National Cerebral and Cardiovascular Center	Osaka
Japan	Saitama Medical Center, Jichi Medical University	Saitama
Japan	Saitama Medical University International Medical Center	Saitama
Japan	Tokushima Red Cross Hospital	Tokushima
Japan	Sakakibara Heart Institute	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Cardiac Surgery	Medtronic

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.