Annular transcatheter heart valve for Aortic Valve Stenosis

Henry Ford, Detroit, MI
Aortic Valve Stenosis+1 More ConditionsTranscatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro - Device
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial looks at two types of valves used to treat heart conditions. The first type is called a supra-annular valve, and the second type is called an annular valve. The trial will compare how well each type of valve works in patients with small annuli (a heart condition that affects the size of the heart).

Eligible Conditions
  • Aortic Valve Stenosis
  • Heart Valve Prosthesis Implantation

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 1 month

1 month
Composite endpoint of patient prosthesis mismatch and >= moderate paravalvular regurgitation
30 days
Pacemaker implantation
VARC-2 30-day early safety and efficacy
Year 1
Prosthetic Valve Dysfunction

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Annular transcatheter heart valve
1 of 2
Supra-Annular transcatheter heart valve
1 of 2

Active Control

150 Total Participants · 2 Treatment Groups

Primary Treatment: Annular transcatheter heart valve · No Placebo Group · N/A

Annular transcatheter heart valve
Device
ActiveComparator Group · 1 Intervention: Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro · Intervention Types: Device
Supra-Annular transcatheter heart valve
Device
ActiveComparator Group · 1 Intervention: Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month

Who is running the clinical trial?

Marvin EngLead Sponsor
William Beaumont HospitalsOTHER
143 Previous Clinical Trials
112,905 Total Patients Enrolled
Marvin Eng, MDPrincipal Investigator - University of Arizona
Henry Ford Health System, Henry Ford Hospital, Henry Ford Macomb Hospital, Henry Ford West Bloomfield Hospital
Wayne State University School Of Medicine (Medical School)
University Co Hlth Sci Center (Residency)
1 Previous Clinical Trials

Eligibility Criteria

Age Any Age · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have severe narrowing of your heart's aortic valve and are experiencing symptoms.
You are eligible for transcatheter aortic valve replacement (TAVR) according to standard medical guidelines.
Your heart's shape and size are suitable for either the Medtronic Evolute or Edwards Sapien 3 Ultra.

Frequently Asked Questions

How many participants have been enlisted in this clinical experiment?

"Affirmative. Clinicaltrials.gov is currently showcasing information which reflects that this medical research project was first published on May 4th 2020, and has been modified recently on April 29th 2020. The objective of the trial is to enrol 150 patients at one site." - Anonymous Online Contributor

Unverified Answer

Are there any open positions left for participants in this clinical research?

"Affirmative. Clinicaltrials.gov attests that this research project, which was initially advertised on May 4th 2020, is actively seeking volunteers. Around 150 candidates need to be enrolled from a single healthcare facility." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.