Transcatheter Aortic Prosthesis Function: A Long-term Follow-up Study

Aortic Valve Replacement Clinical Trial

Official title:

Transcatheter Aortic Prosthesis Function: A Long-term Follow-up Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03002272
• Other study ID #: TAVR Durability
• Status: Recruiting
• Start date: February 20, 2018
• Est. completion date: January 2028

Study information

• Verified date: May 2023
• Source: Medstar Health Research Institute
• Contact: Megan Rowland, MPH
• Phone: 202-877-2959
• Email: megan.e.rowland[@]medstar.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this observational study, the investigators will enroll subjects who underwent TAVR or SAVR more than 3 years ago. Clinical and procedural data from the implant/surgery will be collected, alongside clinical and echocardiographic data from subsequent follow-up visits.

Description:

There is limited available information on long term TAVR valve function. In this observational study, the investigators will enroll subjects who underwent TAVR or SAVR more than 3 years ago. Clinical and procedural data from the implant/surgery will be collected, alongside clinical and echocardiographic data from subsequent follow-up visits. Up-to-date echocardiography will be performed and analyzed in a Core Lab to assess valve function yearly.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2028
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria for TAVR subjects

a) TAVR performed more than 3 years ago

Exclusion criteria

1. Subjects unable to consent to participate, unless the subject has a legally authorized representative

2. Subjects unwilling to participate

3. Subject has undergone re-intervention to prosthetic aortic valve since TAVR procedure (e.g. balloon valvuloplasty, SAVR, re-do TAVR, paravalvular leak closure)

4. Echocardiographic evidence of prosthetic valve dysfunction within first 3 years post-TAVR (mean aortic gradient =20mmHg AND/OR moderate-severe transvalvular aortic regurgitation)

Inclusion criteria for SAVR subjects

1. SAVR performed more than 3 years ago

2. Propensity matched to an enrolled TAVR subject

Exclusion criteria for SAVR subjects e) Subjects unable to consent to participate, unless the subject has a legally authorized representative f) Subjects unwilling to participate g) Subject has undergone re-intervention to prosthetic aortic valve since TAVR procedure (e.g. balloon valvuloplasty, SAVR, re-do TAVR, paravalvular leak closure) h) Echocardiographic evidence of prosthetic valve dysfunction within first 3 years post-SAVR (mean aortic gradient =20mmHg AND/OR moderate-severe transvalvular aortic regurgitation)

Related Conditions & MeSH terms

• Aortic Valve Replacement

Intervention

Device:
• TAVR
subjects that underwent TAVR more than 3 years ago
• SAVR
Historical controls will be selected from among patients at the same site who underwent isolated bioprosthetic SAVR more than 3 years ago

Locations

Country	Name	City	State
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prosthetic valve dysfunction	Mean aortic valve gradient =20 mm Hg Moderate-severe transvalvular aortic regurgitation	7 years
Secondary	Change in functional status	Change in functional status from baseline and discharge per NYHA classification	discharge from hospital
Secondary	Increase in severity of aortic regurgitation	Increase in severity of aortic regurgitation by one or more grading of severity	upto 7 years