NCT05241821

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
484

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 16, 2022

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

8 months

First QC Date

February 5, 2022

Last Update Submit

February 5, 2022

Conditions

StrokeAortic Valve StenosisPeriprocedural Complication

Keywords

periprocedural stroketranscatheter aortic valve implantationtranscatheter aortic valve replacement

Outcome Measures

Primary Outcomes (2)

  • All cause mortality

    All cause death

    1-year

  • Neurologic disability free survival

    modified rankin score (mRS) 0/1

    90 days

Secondary Outcomes (1)

  • Bleeding complications

    30 days

Study Arms (2)

Conservative treatment

patients with periprocedural stroke after TAVI, treated conservatively

Neuro-intervention

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

Procedure: Mechanical thrombectomyDrug: Thrombolytic Agent

Interventions

Mechanical thrombectomyPROCEDURE

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

Neuro-intervention
Thrombolytic AgentDRUG

Drug aimed to dissolve thrombus affecting the cerebral circulation

Neuro-intervention

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with periprocedural stroke complicating TAVI

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel

Location

MeSH Terms

Conditions

StrokeAortic Valve Stenosis

Interventions

Fibrinolytic Agents

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesAortic Valve DiseaseHeart Valve DiseasesHeart DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Fibrin Modulating AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesCardiovascular AgentsTherapeutic UsesHematologic Agents

Study Officials

  • Ran Kornowski, MD

    Head of cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 5, 2022

First Posted

February 16, 2022

Study Start

June 1, 2021

Primary Completion

January 31, 2022

Study Completion

February 5, 2022

Last Updated

February 16, 2022

Record last verified: 2022-02

Locations

IL(1)