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Acute STROke Complicating TAVI - Management and Outcomes

NCT ID: NCT05241821

Last Updated: 2022-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

484 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-02-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Stroke Aortic Valve Stenosis Periprocedural Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Conservative treatment

patients with periprocedural stroke after TAVI, treated conservatively

No interventions assigned to this group

Neuro-intervention

patients with periprocedural stroke after TAVI, treated with neuro-intervention

Mechanical thrombectomy

Intervention Type PROCEDURE

Percutaneous intervention aimed to retrieve/treat clot affecting the cerebral circulation.

Thrombolytic Agent

Intervention Type DRUG

Drug aimed to dissolve thrombus affecting the cerebral circulation

Interventions

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Mechanical thrombectomy

Percutaneous intervention aimed to retrieve/treat clot affecting the cerebral circulation.

Intervention Type PROCEDURE

Thrombolytic Agent

Drug aimed to dissolve thrombus affecting the cerebral circulation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Amos Levi

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ran Kornowski, MD

Role: PRINCIPAL_INVESTIGATOR

Head of cardiology

Locations

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Rabin Medical Center

Petah Tikva, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0502-21

Identifier Type: -

Identifier Source: org_study_id

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