Comparison Between Manta and Prostar Closure Devices
Use of the Closure Device in Patient With Percutaneous Transfemoral Aortic Valve Replacement
1 other identifier
observational
250
1 country
1
Brief Summary
Use of the closure device in patient with percutaneous transfemoral aortic valve replacement
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2021
CompletedFirst Submitted
Initial submission to the registry
November 15, 2022
CompletedFirst Posted
Study publicly available on registry
December 22, 2022
CompletedDecember 22, 2022
December 1, 2022
1.2 years
November 15, 2022
December 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Safety endpoints during index hospitalisation
Major vascular complications,
2018 - 2020
Safety endpoints during index hospitalisation ( bleeding)
life-threatining-, major bleeding
2018-2020
Safety endpoints during index hospitalisation ( death )
death
2018-2020
Secondary Outcomes (3)
efficacy endpoints during index hospitalisation - (hemotasis)
2018-2020
efficacy endpoints during index hospitalisation ( device failure)
2018-2020
efficacy endpoints during index hospitalisation ( bail-out )
2018-2020
Other Outcomes (1)
preperation time
2018-2020
Study Arms (2)
Pro Star
patient received Pro Star Device
MANTA
Patient received MANTA Device
Interventions
Eligibility Criteria
Patient with planned treatment of aortic valve replacement will be asked to participate in the observational study
You may qualify if:
- Patient scheduled for treatment with the TAVR device 2. Decision to use the Manta or the Prostar closure device on a clinical base by the treating physician 3. Signed informed consent
You may not qualify if:
- Male or female aged \< 18 2. Pregnant and lactating females 3. Patient has been committed to an institution by legal or regulatory order
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitätsklinikum Aachen
Aachen, North Rhine-Westphalia, 52074, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jörg Schröder
Universitätsklinikum Aachen Medizinische Klinik 1
- PRINCIPAL INVESTIGATOR
Michael Lehrke
Universitätsklinikum Aachen Medizinische Klinik 1
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 14 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PD Dr. med Jörg Schröder
Study Record Dates
First Submitted
November 15, 2022
First Posted
December 22, 2022
Study Start
January 20, 2020
Primary Completion
March 30, 2021
Study Completion
March 30, 2021
Last Updated
December 22, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share
Study results will be published in an appropriate scientific journal. The Ethics Committee will be informed about the study results.