Acute STROke Complicating TAVI - Management and Outcomes

Completed

• Conditions: Periprocedural Complication; Stroke; Aortic Valve Stenosis
• Interventions: Procedure: Mechanical thrombectomy; Drug: Thrombolytic Agent

• Registration Number: NCT05241821
• Lead Sponsor: Rabin Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Primary Completion: 2022-01-31
• Status Verified: 2022-02
• Study Completion: 2022-02-05
• Study First Submitted: 2022-02-05
• Study First Submitted QC: 2022-02-05
• Last Update Submitted: 2022-02-05
• Study First Posted: 2022-02-16
• Last Update Posted: 2022-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 484

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neuro-intervention	Mechanical thrombectomy	patients with periprocedural stroke after TAVI, treated with neuro-intervention
Neuro-intervention	Thrombolytic Agent	patients with periprocedural stroke after TAVI, treated with neuro-intervention

Primary Outcome Measures

Name	Time	Method
Neurologic disability free survival	90 days	modified rankin score (mRS) 0/1
All cause mortality	1-year	All cause death

Secondary Outcome Measures

Name	Time	Method
Bleeding complications	30 days	Severe bleeding / life-threatening bleeding as defined by VARC2 criteria

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petah tikva, Israel