ASTRO-TAVI: Acute STROke Complicating TAVI - Management and Outcomes

• Sponsor: Rabin Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT05241821
• Collaborator: (none)
• Enrollment: 484
• Location: 1
• Actual Duration (Months): 8.2
• Patients Per Site Per Month: 59.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Aortic Valve Stenosis; Periprocedural Complication	Procedure: Mechanical thrombectomy; Drug: Thrombolytic Agent

Study Design

• Study Type: Observational
• Actual Enrollment: 484 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Management and Outcomes of Acute STROke Complicating Transcatheter Aortic Valve Implantation
• Actual Study Start Date: Jun 1, 2021
• Actual Primary Completion Date: Jan 31, 2022
• Actual Study Completion Date: Feb 5, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. All cause mortality [1-year]

   All cause death

2. Neurologic disability free survival [90 days]

   modified rankin score (mRS) 0/1

Secondary Outcome Measures

1. Bleeding complications [30 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rabin Medical Center	Petah tikva		Israel

Sponsors and Collaborators

• Rabin Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amos Levi, MD, Rabin Medical Center
• ClinicalTrials.gov Identifier: NCT05241821
• Other Study ID Numbers: 0502-21
• First Posted: Feb 16, 2022
• Last Update Posted: Feb 16, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Amos Levi, MD, Rabin Medical Center: periprocedural stroke; transcatheter aortic valve implantation; transcatheter aortic valve replacement
• Additional relevant MeSH terms: Stroke; Aortic Valve Stenosis; Fibrinolytic Agents

Study Results

No Results Posted as of Feb 16, 2022