Model 400 aortic valve bioprosthesis for Aortic Stenosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Aortic StenosisModel 400 aortic valve bioprosthesis - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study the safety and effectiveness of a new aortic valve.

Eligible Conditions
  • Aortic Stenosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Patients are followed through 5yrs

Patients are followed through 5yrs
Confirm the effectiveness of the Model 400 valve, with regard to NYHA Functional Classification and hemodynamic performance.
Evaluate the safety of the Model 400 valve with regard to valve-related adverse events and death.

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Model 400 aortic valve bioprosthesis
1 of 1

Experimental Treatment

1290 Total Participants · 1 Treatment Group

Primary Treatment: Model 400 aortic valve bioprosthesis · No Placebo Group · N/A

Model 400 aortic valve bioprosthesis
Device
Experimental Group · 1 Intervention: Model 400 aortic valve bioprosthesis · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: patients are followed through 5yrs

Who is running the clinical trial?

Medtronic CardiovascularLead Sponsor
74 Previous Clinical Trials
35,177 Total Patients Enrolled
Medtronic Cardiac SurgeryLead Sponsor
5 Previous Clinical Trials
8,071 Total Patients Enrolled
MedtronicIndustry Sponsor
574 Previous Clinical Trials
731,601 Total Patients Enrolled
Joseph Sabik, MDPrincipal InvestigatorUniversity Hospital Cleveland Medical Center (Not a recruiting site)
2 Previous Clinical Trials
2,905 Total Patients Enrolled
Prof. Dr. Robert Johannes Menno Klautz, MDPrincipal InvestigatorLeiden University Medical Center

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing to return to the implanting site for all follow-up visits.
Patient is of legal age to provide informed consent in the country where they enroll in the trial.