Evaluating closure techniques after heart valve replacement
Randomized Trial Comparing Dual Perclose Vs Single Angioseal And Perclose in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement
NA · Baylor Research Institute · NCT06983938
This study is testing whether using two ProGlide devices instead of one ProGlide and Angioseal to close the femoral artery after heart valve replacement is safer and leads to fewer complications for patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Baylor Research Institute (other) |
| Locations | 1 site (Plano, Texas) |
| Trial ID | NCT06983938 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and potential complications of using dual ProGlide versus single ProGlide and Angioseal for closing the femoral artery after a transcatheter aortic valve replacement. It is a prospective, randomized, parallel, open-label, single-center, non-inferiority study involving approximately 90 patients. Participants will be randomly assigned to one of the two closure techniques, and the study will assess various outcomes including bleeding complications and hospitalization costs. Follow-up assessments will occur 30 days post-procedure to monitor any clinical changes or complications.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for transcatheter aortic valve replacement via femoral access.
Not a fit: Patients who require non-femoral access or have a history of complications related to the common femoral artery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve closure techniques, potentially reducing complications and hospital stays for patients undergoing heart valve replacement.
How similar studies have performed: Other studies have explored similar closure techniques, but this specific comparison of dual versus single ProGlide and Angioseal is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years old * Planned to undergo transcatheter aortic valve replacement via femoral access * Able to provide written informed consent prior to study participation Exclusion Criteria: * Non-femoral access * Previous repair or intervention of the common femoral artery * Previous pseudoaneurysm of the common femoral artery * Children below 18 years, prisoners, and patients who are unable to provide consent are excluded. * In another research study that has not granted permission to dual-enroll.
Where this trial is running
Plano, Texas
- Baylor Scott & White The Heart Hospital - Plano — Plano, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Bonnie Ostergren
- Email: Bonnie.Ostergren@bswhealth.org
- Phone: 469-814-4181
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: Transcatheter Aortic Valve Replacement, Closure Technique, Transcatheter aortic valve replacement, Perclose Proglide, Angioseal