Cardiac Arrest, Transcatheter Aortic Valve ImplantationNCT04687202
The Clinical Characteristics, Management and Prognosis of Patients Developing Intraoperative Cardiac Arrest During Transcatheter Aortic Valve Implantation
An observational study of Cardiac Arrest, Transcatheter Aortic Valve Implantation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study was aimed to investigate the clinical characteristics, management and prognosis of patients developing intraoperative cardiac arrest during transcatheter aortic valve implantation Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiac Arrest, Transcatheter Aortic Valve Implantation
- What is being tested?
- follow up and record
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 31 Dec 2021
- 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 18 to 100 years
- All sexes
- Adult, Older adult
Study population: patients who developed intraoperative cardiac arrest during transcatheter aortic valve implantation from January 2014 to May 2019
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, 310009
Kai Sun, MD, 18357110862, occean_chen@126.com
About this study
This study was aimed to investigate the clinical characteristics, management and prognosis of patients developing intraoperative cardiac arrest during transcatheter aortic valve implantation
- Being tested
- follow up and record
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follow up and recordOther
None additional intervention was applied to the subjects.
| Study group | Role | What they receive |
|---|---|---|
| Patients developing CA | Including patients developing intraoperative cardiac arrest during transcatheter aortic valve implantation from January 2014 to May 2019 Receives: Other: follow up and record |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
In-hospital mortality
Measured: 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start1 May 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Arrest, Transcatheter Aortic Valve ImplantationStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687202
- Sponsor's protocol ID
- 研2019-125
- Status last verified
- Dec 2020
- First submitted
- 24 Dec 2020
- Last updated
- 29 Dec 2020
- Results posted
- 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 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Characteristics, Management and Prognosis of Patients Developing Intraoperative Cardiac Arrest During Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT04687202
- Acronym / sponsor ID
- 研2019-125
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 29 Dec 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.
This study was aimed to investigate the clinical characteristics, management and prognosis of patients developing intraoperative cardiac arrest during transcatheter aortic valve implantation
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients developing CA | – | Other: follow up and recordIncluding patients developing intraoperative cardiac arrest during transcatheter aortic valve implantation from January 2014 to May 2019 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients who developed intraoperative cardiac arrest during transcatheter aortic valve implantation from January 2014 to May 2019
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| follow up and recordNone additional intervention was applied to the subjects. | Other | Patients developing CA |
Primary outcome
Mortality
Time frame: 1month
In-hospital mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Individual participant dataSharing planned: No
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.
Second Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou, China
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 Cardiac Arrest, Transcatheter Aortic Valve Implantation, 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 0 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: status not confirmed, as of the sponsor's last update on 29 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 1month). 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 29 Dec 2020.