Clinical trial NCT02686814: PERIGON Japan 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Stenosis
Keywords: Valvular heart disease
Severe aortic stenosis
Aortic valve replacement
Lead sponsor: Medtronic Cardiac Surgery
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2016-02-22
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of the 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.)

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Changes in NYHA Classification From Baseline to 1 Year Post-procedure
timeFrame: This outcome will be identified from measurement at baseline and 1 year.
measure: Effective Orifice Area Index at Baseline and 1 Year Post-procedure
timeFrame: This outcome will be measured at 1 year.
measure: Number of Participants With Composite New York Heart Association (NYHA) Classification and Effective Orifice EOAI Endpoint Improvement From Baseline to 1 Year
timeFrame: This outcome will be identified from measurement at baseline and 1 year.
Secondary outcomes:
measure: Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
timeFrame: This outcome will be evaluated at baseline, discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
measure: Mean Effective Orifice Area Index (cm^2/m^2) From Baseline up to 5 Years
timeFrame: This outcome will be evaluated at baseline, discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
measure: Effective Orifice Area (cm^2) From Baseline up to 5 Years
timeFrame: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
measure: Peak Pressure Gradient (mmHg) From Discharge up to 5 Years
timeFrame: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
measure: Mean Pressure Gradient (mmHg) From Discharge up to 5 Years
timeFrame: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
measure: Degree of Paravalvular Regurgitation From Discharge up to 5 Years
timeFrame: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
measure: Degree of Transvalvular Regurgitation From Discharge up to 5 Years
timeFrame: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
measure: Degree of Total Valvular Regurgitation From Discharge up to 5 Years
timeFrame: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
measure: Performance Index (L/Min) From Discharge up to 5 Years
timeFrame: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
measure: Cardiac Output (L/Min) From Discharge up to 5 Years
timeFrame: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
measure: Cardiac Index (L/Min/m^2) From Discharge up to 5 Years
timeFrame: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
measure: Safety:Valve-related Adverse Events
timeFrame: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.
measure: Quality of Life Assessment - Physical Component Summary (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality)
timeFrame: This outcome will be evaluated at baseline, 3-6 months, 1 year and annually thereafter up to 5 years.
measure: Quality of Life Assessment - Mental Component Summary (Social Functioning, Role-emotional, Mental Health)
timeFrame: This outcome will be evaluated at baseline, 3-6 months, 1 year and annually thereafter up to 5 years.
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: Chiba-Nishi General Hospital
city: Hyogo Prefecture
country: Japan
facility: Kobe University Hospital
city: Hyogo Prefecture
country: Japan
facility: Hyogo Prefectural Harima-Himeji General Medical Center
city: Kyoto
country: Japan
facility: University Hospital, Kyoto Prefectural University of Medicine
city: Okayama
country: Japan
facility: Kurashiki Central Hospital
city: Osaka
country: Japan
facility: National Cerebral and Cardiovascular Center
city: Saitama
country: Japan
facility: Saitama Medical Center, Jichi Medical University
city: Saitama
country: Japan
facility: Saitama Medical University International Medical Center
city: Tokushima
country: Japan
facility: Tokushima Red Cross Hospital
city: Tokyo
country: Japan
facility: Sakakibara Heart Institute
Study officials:
affiliation: Kobe University Hospital, Japan
name: Yutaka Okita, MD
role: PRINCIPAL_INVESTIGATOR
References: