R57.0
Conditions
Interventions
Group 1: 50 patients with deployment of the suture-based vascular closure system already at the time of Impella implantation
Group 2: 50 patients with deployment of the suture-based vascular closure s
Sponsors
Universitätsklinikum Heidelberg - Abteilung für Kardiologie, Angiologie und Pneumologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Transfemoral Impella implantation
Exclusion criteria
Exclusion criteria: - Mechanical aortic valve replacement - Severe peripheral arterial disease precluding transfemoral Impella implantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite endpoint of bleeding events =BARC 3a, vascular and access-site-related complications excluding bleeding, and 30-day all-cause mortality | — |
Secondary
| Measure | Time frame |
|---|---|
| - Life-threatening bleeding events (BARC 3b/5) - Major bleeding events (BARC 3a) - Major vascular and access-site-related complications, excluding bleeding - Minor vascular and access-site-related complications, excluding bleeding - Need for transfusion - Length of hospital stay - 30-day all-cause mortality | — |
Countries
Germany
Contacts
Public ContactEbe Amr
Universitätsklinikum Heidelberg - Abteilung für Kardiologie, Angiologie und Pneumologie
Outcome results
None listed