N/A
Completed N=92
This Study Will Evaluate the Safety and Potential Complications of Dual ProGlide vs Single ProGlide and Angioseal for Common Femoral Arteriotomy Closure Following Transcatheter Aortic Valve Replacement
transcatheter aortic valve replacement · Closure Technique
Source: ClinicalTrials.gov NCT06983938 ↗
Enrolled (actual)
92
Serious AEs
1.1%
Results posted
Mar 2026
Primary outcomePrimary: Number of Participants With Main Access-related Bleeding and Vascular Complications — 47; 42 Participants
Summary
This prospective, randomized, parallel, single-center, open-label, non-inferiority study will evaluate the safety and potential complications of dual ProGlide vs single ProGlide and Angioseal for common femoral arteriotomy closure following Transcatheter Aortic Valve Replacement.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Main Access-related Bleeding and Vascular Complications |
47; 42 | — |
| SECONDARY The Number of Participants With Periprocedural Complications, What the Procedural Characteristics Are, and Hospitalization. |
47; 42 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT06983938). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.