PERIGON Japan Trial

Status Completed

Clinical Trial Summary

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02686814
Study type	Interventional
Source	Medtronic Cardiac Surgery
Contact
Status	Completed
Phase	N/A
Start date	March 2016
Completion date	July 15, 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04310046` - Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial	N/A
Completed	`NCT03332745` - Mechanism of Decompensation Evaluation - Aortic Stenosis
Recruiting	`NCT06008080` - Post-Market Clinical Follow Up Study With Navitor Valve
Recruiting	`NCT06055751` - Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry
Active, not recruiting	`NCT04815785` - Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis	N/A
Terminated	`NCT02202434` - Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement	N/A
Recruiting	`NCT03029026` - The Role of Occult Cardiac Amyloid in the Elderly With Aortic Stenosis.
Active, not recruiting	`NCT02903420` - A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan)	N/A
Completed	`NCT02629328` - CardioCel Tri-leaflet Repair Study	N/A
Completed	`NCT02306226` - Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry
Withdrawn	`NCT01648309` - Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation	N/A
Completed	`NCT01676727` - ADVANCE Direct Aortic Study
Completed	`NCT01422044` - Risk Prediction in Aortic Stenosis	N/A
Withdrawn	`NCT00774657` - Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography	N/A
Terminated	`NCT00535899` - Speckle Tracking Imaging in Patients With Low Ejection Fraction Aortic Stenosis (SPArKLE-AS)	N/A
Terminated	`NCT05070130` - OpSens PRIME CLASS
Completed	`NCT03314857` - China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population	N/A
Completed	`NCT04157920` - Impact of Predilatation Between Self-expanding Valves	N/A
Enrolling by invitation	`NCT06212050` - Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
Recruiting	`NCT05893082` - Multicenter Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR	N/A