Acute STROke Complicating TAVI - Management and Outcomes (ASTRO-TAVI)

February 5, 2022 updated by: Amos Levi, Rabin Medical Center

Management and Outcomes of Acute STROke Complicating Transcatheter Aortic Valve Implantation

Periprocedural complications of trans catheter aortic valve implantation, and particularly the occurrence of stroke has a marked impact on survival and quality of life. The characteristics of periprocedural stroke complicating TAVI, and particularly of interventions aimed to treat stroke complicating TAVI have not been systematically described. We therefore aimed is to explore the incidence and characteristics of acute stroke complicating TAVI and to describe the safety and efficacy of emergent interventions to treat acute stroke complicating TAVI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

484

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

  • Israel
      • Petah tikva, Israel
        • Rabin Medical Center

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

18 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with periprocedural stroke complicating TAVI

Description

Inclusion Criteria:

  • patients who have had a stroke within 30 days of TAVI

Exclusion Criteria:

  • none

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Conservative treatment
patients with periprocedural stroke after TAVI, treated conservatively
Neuro-intervention
patients with periprocedural stroke after TAVI, treated with neuro-intervention
Procedure: Mechanical thrombectomy
Percutaneous intervention aimed to retrieve/treat clot affecting the cerebral circulation.
Drug: Thrombolytic Agent
Drug aimed to dissolve thrombus affecting the cerebral circulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause mortality
Time Frame: 1-year
All cause death
1-year
Neurologic disability free survival
Time Frame: 90 days
modified rankin score (mRS) 0/1
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding complications
Time Frame: 30 days
Severe bleeding / life-threatening bleeding as defined by VARC2 criteria
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Investigators

  • Principal Investigator: Ran Kornowski, MD, Head of cardiology

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)

June 1, 2021

Primary Completion (ACTUAL)

January 31, 2022

Study Completion (ACTUAL)

February 5, 2022

Study Registration Dates

First Submitted

February 5, 2022

First Submitted That Met QC Criteria

February 5, 2022

First Posted (ACTUAL)

February 16, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 5, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0502-21

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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