N/A Completed N=25 Treatment

PERIGON Japan Trial

Source: ClinicalTrials.gov NCT02686814 ↗

Enrolled (actual)

Serious AEs

18.2%

Results posted

Apr 2024

Primary outcomePrimary: Number of Participants With Changes in NYHA Classification From Baseline to 1 Year Post-procedure — 10; 1 Participants

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Changes in NYHA Classification From Baseline to 1 Year Post-procedure	10; 1	—
PRIMARY Effective Orifice Area Index at Baseline and 1 Year Post-procedure	0.44; 0.82	—
PRIMARY Number of Participants With Composite New York Heart Association (NYHA) Classification and Effective Orifice EOAI Endpoint Improvement From Baseline to 1 Year	9	—
SECONDARY Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years	0; 11; 0; 0; 0; 0	—
SECONDARY Mean Effective Orifice Area Index (cm^2/m^2) From Baseline up to 5 Years	0.44; 0.82; 0.77; 0.82; 0.70; 0.78	—
SECONDARY Effective Orifice Area (cm^2) From Baseline up to 5 Years	0.58; 1.08; 1.03; 1.10; 0.96; 1.05	—
SECONDARY Peak Pressure Gradient (mmHg) From Discharge up to 5 Years	85.3; 33.5; 36.5; 34.7; 35.6; 32.5	—
SECONDARY Mean Pressure Gradient (mmHg) From Discharge up to 5 Years	53.3; 18.5; 20.6; 20.9; 20.3; 18.8	—
SECONDARY Degree of Paravalvular Regurgitation From Discharge up to 5 Years	8; 1; 1; 1; 0; 0	—
SECONDARY Degree of Transvalvular Regurgitation From Discharge up to 5 Years	1; 0; 8; 1; 1; 0	—
SECONDARY Degree of Total Valvular Regurgitation From Discharge up to 5 Years	1; 0; 7; 1; 2; 0	—
SECONDARY Performance Index (L/Min) From Discharge up to 5 Years	0.3; 0.6; 0.5; 0.6; 0.5; 0.6	—
SECONDARY Cardiac Output (L/Min) From Discharge up to 5 Years	4.0; 4.0; 3.9; 4.4; 3.7; 3.8	—
SECONDARY Cardiac Index (L/Min/m^2) From Discharge up to 5 Years	3.0; 3.0; 3.0; 3.3; 2.6; 2.8	—
SECONDARY Safety:Valve-related Adverse Events	0; 0; 0; 0	—
SECONDARY Quality of Life Assessment - Physical Component Summary (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality)	37.4; 35.5; 39.2; 39.5; 26.6; 36.1	0.7646
SECONDARY Quality of Life Assessment - Mental Component Summary (Social Functioning, Role-emotional, Mental Health)	52.0; 55.2; 57.3; 57.9; 53.0; 53.5	0.2783

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02686814). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.