Vascular Closure Device in Transcatheter Aortic Valve Replacement
- Conditions
- Aortic Valve Stenosis
- Registration Number
- NCT04392492
- Lead Sponsor
- Karolinska University Hospital
- Brief Summary
Evaluation of the safety and efficacy of a percutaneous plug-based large-bore vascular closure device for femoral artery closure in an unselected consecutive patient cohort undergoing transcatheter aortic valve implantation in a single-center prospective study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
Inclusion Criteria
- Patients undergoing transfemoral TAVI at the Karolinska University Hospital
Exclusion Criteria
- Patients undergoing TAVI with access other than transfemoral
- Use of closure device other than MANTA
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of patients with major vascular complications 6 week follow up Major vascular access site complications according to the VARC-2 definitions
- Secondary Outcome Measures
Name Time Method Number of patients with minor vascular complications 6 week follow up Minor vascular access site complications according to the VARC-2 definitions
Number of patients with vascular closure device failure 6 week follow up Percutaneous vascular closure device failure according to the VARC-2 definitions
Number of patients with life-threatening, disabling or major bleeding 6 week follow up Life-threatening, disabling or major bleeding complications according to the BARC definitions
Trial Locations
- Locations (1)
Department of Cardiology, Karolinska University Hospital
🇸🇪Stockholm, Sweden
Department of Cardiology, Karolinska University Hospital🇸🇪Stockholm, Sweden