PERIGON Pivotal Trial

• Sponsor: Medtronic Cardiac Surgery (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT02088554
• Collaborator: Medtronic (Industry)
• Enrollment: 1,290
• Locations: 39
• Arm: 1
• Anticipated Duration (Months): 259.6
• Patients Per Site: 33.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.

Condition or Disease	Intervention/Treatment	Phase
Aortic Stenosis	Device: Model 400 aortic valve bioprosthesis	N/A

Detailed Description

This is a prospective, interventional, non-randomized, worldwide, multi-center trial, with each site following a common protocol. A maximum of 1300 subjects will be implanted at a maximum of 40 sites in the US, Europe and Canada. The trial will include male and female patients of legal age to provide informed consent in the country where they enroll in the trial, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic valve. Subjects will be followed out to 5 years and select sites will follow subjects out to 12 years. Enrollment is currently open to capture additional data sets for the size 29mm valve only.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1290 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Medtronic PERIcardial SurGical AOrtic Valve ReplacemeNt Pivotal Trial A Multi-center, Non-randomized Trial to Determine the Safety and Effectiveness of the Model 400 Aortic Valve Bioprosthesis in Patients With Aortic Valve Disease
• Actual Study Start Date: May 12, 2014
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2035

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Model 400 aortic valve bioprosthesis	Device: Model 400 aortic valve bioprosthesis

Outcome Measures

Primary Outcome Measures

1. Evaluate the safety of the Model 400 valve with regard to valve-related adverse events and death. [Patients are followed through 5yrs]

   Safety of the valve will be evaluated by the time-related incidence of valve-related adverse events and death. The following valve-related adverse events will be evaluated in this study: Thromboembolism, Thrombosis, Hemorrhage, Paravalvular leak (PVL), Endocarditis, Hemolysis, Structural valve deterioration, Non-structural dysfunction, Reintervention, Explant, and Death.

Secondary Outcome Measures

1. Confirm the effectiveness of the Model 400 valve, with regard to NYHA Functional Classification and hemodynamic performance. [Patients are followed through 5yrs]

   The effectiveness endpoints are: New York Heart Association Functional Classification (at discharge (or 30 days), 3-6 months, 1 year and annually thereafter through 5 years) as compared to Baseline. Clinically acceptable Hemodynamic Performance (at discharge (or 30 days), 3-6 months, 1 year and annually thereafter through 5 years) confirmed by core lab evaluation of echocardiography.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patient has moderate or greater 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:

1. LAA ligation ii. CABG iii. PFO closure iv. Ascending aortic aneurysm or dissection repair not requiring circulatory arrest v. Resection of a sub-aortic membrane not requiring myectomy

1. Patient is geographically stable and willing to return to the implanting site for all follow-up visits

2. Patient is of legal age to provide informed consent in the country where they enroll in the trial

3. 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

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 Model 400 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)

1. 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

1. Patient has renal failure, defined as dialysis therapy or GFR<30 mL/min/1.73 m2

2. Patient has hyperparathyroidism

3. Patient is participating in another investigational device or drug trial or observational competitive study

4. Patient is pregnant, lactating or planning to become pregnant during the trial period

5. Patient has a documented history of substance (drug or alcohol) abuse

6. Patient has greater than mild mitral valve regurgitation or greater than mild tricuspid valve regurgitation as assessed by echocardiography

7. Patient has systolic EF<20% as assessed by echocardiography

8. Patient has Grade IV Diastolic Dysfunction

9. Patient has documented bleeding diatheses

10. Patient has had an acute preoperative neurological deficit or myocardial infarction and has not returned to baseline or stabilized ≥30 days prior to enrollment

11. Patient requires emergency surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Southern California (USC) University Hospital	Los Angeles	California	United States	90033-5313
2	Stanford Hospitals and Clinics	Stanford	California	United States	94305
3	University of Colorado Hospital	Aurora	Colorado	United States	80045-2545
4	Hartford Hospital	Hartford	Connecticut	United States	06102
5	University of Florida Shands	Gainesville	Florida	United States	32610
6	Piedmont Hospital	Atlanta	Georgia	United States	30309
7	University of Maryland Medical Center	Baltimore	Maryland	United States	21201
8	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
9	University of Michigan Cardiovascular Center	Ann Arbor	Michigan	United States	48109-5853
10	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota	United States	55407-1139
11	Maimonides Medical Center	Brooklyn	New York	United States	11219
12	The Mount Sinai Medical Center	New York	New York	United States	10029
13	New York-Presbyterian Hospital/Columbia University Medical Center	New York	New York	United States	10032
14	Cleveland Clinic	Cleveland	Ohio	United States	44195-0001
15	Riverside Methodist Hospital (OhioHealth)	Columbus	Ohio	United States	43214
16	ProMedica Toledo Hospital	Toledo	Ohio	United States	43606
17	Oklahoma Heart Hospital	Oklahoma City	Oklahoma	United States	73135
18	Cardiothoracic and Vascular Surgeons (CTVS)	Austin	Texas	United States	78756-4080
19	Houston Methodist Hospital	Houston	Texas	United States	77030
20	University of Washington Medical Center	Seattle	Washington	United States	98195-0001
21	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin	United States	53215-4330
22	London Health Sciences Centre - University Campus	London	Ontario	Canada	N6A 5A5
23	University of Ottawa Heart Institute	Ottawa	Ontario	Canada	K1Y 4W7
24	Montreal Heart Institute	Montreal	Quebec	Canada	H1T 1C8
25	Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)	Quebec		Canada	G1V 4G5
26	Toronto General Hospital	Toronto		Canada	M5G 2C4
27	Hôpital Cardiologique du Haut-Lévêque	Bordeaux		France	33604
28	Hôpital Bichat - Claude Bernard	Paris		France	75018
29	Uniklinik Köln	Cologne	Köln	Germany	50924
30	Deutsches Herzzentrum München	Munich	München	Germany	DE 80636
31	Universitäts Klinikum Frankfurt - Goethe-Universität	Frankfurt		Germany	60590
32	Medizinische Hochschule Hannover	Hannover		Germany	30625
33	Herzzentrum Leipzig GmbH	Leipzig		Germany	04289
34	Ospedale San Raffaele - Milano	Milano		Italy	20132
35	Leids Universitair Medisch Centrum (LUMC)	Leiden		Netherlands	2333 ZA
36	Erasmus MC	Rotterdam		Netherlands	3015 CE
37	Inselspital - Universitätsspital Bern	Bern		Switzerland	3010
38	UniversitätsSpital Zürich	Zürich		Switzerland	8091
39	Guy's & St Thomas' NHS Foundation Trust - St Thomas' Hospital	London		United Kingdom	SE1 7EH

Sponsors and Collaborators

• Medtronic Cardiac Surgery
• Medtronic

Investigators

• Principal Investigator: Joseph Sabik, MD, University Hospital Cleveland Medical Center (Not a recruiting site)
• Principal Investigator: Prof. Dr. Robert Johannes Menno Klautz, MD, Leiden University Medical Center

Study Documents (Full-Text)

• Study Protocol - Mar 13, 2019
• Statistical Analysis Plan - Mar 3, 2015
• Informed Consent Form - Mar 4, 2015

More Information

Publications

None provided.

• Responsible Party: Medtronic Cardiac Surgery
• ClinicalTrials.gov Identifier: NCT02088554
• Other Study ID Numbers: PERIGON
• First Posted: Mar 17, 2014
• Last Update Posted: Jul 5, 2022
• Last Verified: Jul 1, 2022

• Additional relevant MeSH terms: Aortic Valve Stenosis

Study Results

No Results Posted as of Jul 5, 2022