Long-term follow-up on aortic valve replacement function
Transcatheter Aortic Prosthesis Function: A Long-term Follow-up Study
Medstar Health Research Institute · NCT03002272
This study looks at how well transcatheter and surgical aortic valves work over time in patients who had these procedures more than three years ago.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medstar Health Research Institute (other) |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT03002272 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather long-term data on the function of transcatheter aortic valves (TAVR) and surgical aortic valves (SAVR) in patients who underwent these procedures more than three years ago. Investigators will collect clinical and procedural data from the initial implant or surgery, as well as clinical and echocardiographic data from follow-up visits. Yearly echocardiography assessments will be performed and analyzed in a Core Lab to evaluate valve function over time.
Who should consider this trial
Good fit: Ideal candidates include patients who had TAVR or SAVR procedures performed more than three years ago.
Not a fit: Patients who have undergone re-intervention on their prosthetic aortic valve or have shown early signs of valve dysfunction within the first three years post-procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term performance and durability of aortic valve replacements, improving patient outcomes.
How similar studies have performed: Other studies have explored TAVR and SAVR outcomes, but long-term follow-up data specifically on valve function remains limited, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Washington D.C., District of Columbia
- Washington Hospital Center — Washington D.C., District of Columbia, United States (RECRUITING)
Study contacts
- Study coordinator: Megan Rowland, MPH
- Email: megan.e.rowland@medstar.net
- Phone: 202-877-2959
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aortic Valve Replacement