- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04464356
Application of Emergent Peripheral Mechanical Circulatory Support in Transcatheter Aortic Valve Replacement for 6 Patients
July 6, 2020 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
Objective: To explore the experience of transcranial aortic valve replacement (TAVR) under emergency mechanical assisted circulation (MCS).Methods: A total of 6 patients who completed TAVR with the assistance of emergency MCS in the Second Affiliated Hospital of Zhejiang University School of Medicine from March 2013 to June 2019 were retrospectively analyzed.The management of perioperative mechanical assisted circulation, preoperative evaluation, intraoperative operation and postoperative situation of patients were summarized.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
6
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310009
- Second Affiliated Hospital, School of Medicine, Zhejiang University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients assisted by emergency peripheral MCS during TAVR due to circulatory collapse.
Description
Inclusion Criteria:
- TAVR patient, assisted by emergency peripheral MCS due to circulatory collapse during TAVR
Exclusion Criteria:
- patients presented mechanical complications such as massive hemorrhage, coronary artery occlusion or left ventricular rupture.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
30-Day mortality rate
Time Frame: 30 days after TAVR procedure
|
30-Day mortality rate
|
30 days after TAVR procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2013
Primary Completion (Actual)
June 20, 2019
Study Completion (Actual)
June 1, 2020
Study Registration Dates
First Submitted
June 28, 2020
First Submitted That Met QC Criteria
July 6, 2020
First Posted (Actual)
July 9, 2020
Study Record Updates
Last Update Posted (Actual)
July 9, 2020
Last Update Submitted That Met QC Criteria
July 6, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2020-380
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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