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OpenTrials
Completed

NCT Number: NCT05241821

Acute STROke Complicating TAVI - Management and Outcomes

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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Key information

Conditions

Stroke Aortic Valve Disease Aortic Valve Stenosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Heart Valve Diseases Nervous System Diseases Periprocedural Complication Vascular Diseases Ventricular Outflow Obstruction

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rabin Medical Center

Petah Tikva, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Mechanical thrombectomy

Procedure

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

Thrombolytic Agent

Drug

Drug aimed to dissolve thrombus affecting the cerebral circulation

Primary outcomes

  1. All cause mortality

    Time frame: 1-year

    All cause death

  2. Neurologic disability free survival

    Time frame: 90 days

    modified rankin score (mRS) 0/1

Secondary outcomes

  1. Bleeding complications

    Time frame: 30 days

    Severe bleeding / life-threatening bleeding as defined by VARC2 criteria

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Official study title

Management and Outcomes of Acute STROke Complicating Transcatheter Aortic Valve Implantation

Acronym: ASTRO-TAVI

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 16, 2022
Registry last updated
Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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