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

Launched by MEDSTAR HEALTH RESEARCH INSTITUTE · Dec 21, 2016

Keywords

ClinConnect Summary

The clinical trial titled "Transcatheter Aortic Prosthesis Function: A Long-term Follow-up Study" aims to study how well heart valves, specifically those replaced using two different methods (TAVR and SAVR), are working more than three years after the procedure. The researchers will gather information from patients who have already had these surgeries to see how their heart valves are performing and to track their health during follow-up visits. This study is important because it helps us understand the long-term success of these heart valve replacements.

To be eligible for this study, participants must have had a TAVR (a less invasive valve replacement) or SAVR (a traditional valve replacement) more than three years ago. However, those who have had complications or additional surgeries on their heart valve since their initial procedure cannot participate. If you join the study, you can expect to provide some information about your medical history and undergo tests to check how well your heart valve is functioning. This trial is currently recruiting participants of all genders, aged 65 and older, who are interested in contributing to important research on heart valve replacements.

Gender

ALL

Eligibility 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)