Transcatheter Aortic Valve ReplacementNCT04464356
Application of Emergent Peripheral Mechanical Circulatory Support in Transcatheter Aortic Valve Replacement for 6 Patients
An observational study of Transcatheter Aortic Valve Replacement and Mechanical Circulatory Support, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Transcatheter Aortic Valve Replacement, Mechanical Circulatory Support
- What is being tested?
- mechanical circulatory support
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2013to 1 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: All patients assisted by emergency peripheral MCS during TAVR due to circulatory collapse.
Who may be able to join
- TAVR patient, assisted by emergency peripheral MCS due to circulatory collapse during TAVR
Who cannot join
- patients presented mechanical complications such as massive hemorrhage, coronary artery occlusion or left ventricular rupture.
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
About this study
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.
- Being tested
- mechanical circulatory support
- Keywords
- transcatheter aortic valve replacement, mechanical circulatory support, cardiopulmonary bypass, ,extracorporeal membranous oxygenator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical circulatory supportDevice
mechanical circulatory support: cardiopulmonary bypass, extracorporeal membrane oxygenation(ECMO), left ventricular assist device
What is being measured
The primary outcome is the main question the study is designed to answer.
30-Day mortality rate
30-Day mortality rate
Measured: 30 days after TAVR procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start1 Mar 2013
- Primary completion20 Jun 2019
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Aortic Valve ReplacementStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464356
- Sponsor's protocol ID
- 2020-380
- Status last verified
- Jun 2020
- First submitted
- 28 Jun 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Emergent Peripheral Mechanical Circulatory Support in Transcatheter Aortic Valve Replacement for 6 Patients
- ClinicalTrials.gov ID
- NCT04464356
- Acronym / sponsor ID
- 2020-380
- Keywords
- transcatheter aortic valve replacement, mechanical circulatory support, cardiopulmonary bypass, ,extracorporeal membranous oxygenator
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients assisted by emergency peripheral MCS during TAVR due to circulatory collapse.
Key inclusion criteria (1 listed)
- TAVR patient, assisted by emergency peripheral MCS due to circulatory collapse during TAVR
Key exclusion criteria (1 listed)
- patients presented mechanical complications such as massive hemorrhage, coronary artery occlusion or left ventricular rupture.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mechanical circulatory supportmechanical circulatory support: cardiopulmonary bypass, extracorporeal membrane oxygenation(ECMO), left ventricular assist device | Device | – |
Primary outcome
30-Day mortality rate
Time frame: 30 days after TAVR procedure
30-Day mortality rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Transcatheter Aortic Valve Replacement
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
RecruitingObservational study
Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Not yet recruitingObservational study
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
Aortic Stenosis, Mitral Regurgitation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transcatheter Aortic Valve Replacement and Mechanical Circulatory Support, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-Day mortality rate (time frame: 30 days after TAVR procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.