Trials / Completed
CompletedNCT04459208
Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 516 (actual)
- Sponsor
- Helios Health Institute GmbH · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of the study is to evaluate the clinical efficacy of 2 different vascular closure device (VCD) strategies during transfemoral transcatheter aortic valve implantation (TAVI). The study hypothesizes that the choice of one over the other VCD in patients undergoing transfemoral TAVI may demonstrate relevant differences in the rate of peri-procedural complications and effectiveness of vascular closure.
Detailed description
Use of a plug-based VCD in patients undergoing transfemoral TAVI as compared to a suture-based VCD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Manta | plug-based vascular closure |
| DEVICE | ProGlide | suture-based vascular closure |
Timeline
- Start date
- 2020-06-26
- Primary completion
- 2021-07-07
- Completion
- 2021-08-04
- First posted
- 2020-07-07
- Last updated
- 2021-09-29
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT04459208. Inclusion in this directory is not an endorsement.