NCT04464356

Brief 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 to June 2019 were retrospectively analyzed.The management of perioperative mechanical assisted circulation, preoperative evaluation, intraoperative operation and postoperative situation of patients were summarized.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2013

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
Last Updated

July 9, 2020

Status Verified

June 1, 2020

Enrollment Period

6.3 years

First QC Date

June 28, 2020

Last Update Submit

July 6, 2020

Conditions

Keywords

transcatheter aortic valve replacementmechanical circulatory supportcardiopulmonary bypass,extracorporeal membranous oxygenator

Outcome Measures

Primary Outcomes (1)

  • 30-Day mortality rate

    30-Day mortality rate

    30 days after TAVR procedure

Interventions

mechanical circulatory support: cardiopulmonary bypass, extracorporeal membrane oxygenation(ECMO), left ventricular assist device

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients assisted by emergency peripheral MCS during TAVR due to circulatory collapse.

You may qualify if:

  • TAVR patient, assisted by emergency peripheral MCS due to circulatory collapse during TAVR

You may not qualify if:

  • patients presented mechanical complications such as massive hemorrhage, coronary artery occlusion or left ventricular rupture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2020

First Posted

July 9, 2020

Study Start

March 1, 2013

Primary Completion

June 20, 2019

Study Completion

June 1, 2020

Last Updated

July 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations