HEParin Antagonisation in Transcatheter Aortic Valve Impl... | NCT05422170

Studies
HEParin Antagonisation in Transcatheter Aortic Valve Implantation

NCT05422170

Sponsor

Deutsches Herzzentrum Muenchen

Status

Unknown status

Last Update Posted

Jul 5, 2022Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Aortic Valve Stenosis
Transcatheter Aortic Valve Implantation
Protamine Sulfate Overdose

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2022Estimated

Primary Completion Date

Jan 31, 2023Estimated

Completion Date

Apr 1, 2023Estimated

First Submitted Date

Jun 13, 2022

First Submission Date that Met QC Criteria

Jun 13, 2022

First Posted Date

Jun 16, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2022

Last Update Posted Date

Jul 5, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Unfractioned heparin is usually given in a defined dosage during transfemoral TAVI. Activated Clotting Time (ACT) is usually used to measure the heparin effect. ACT-analysis is easy to perform at the bedside, but susceptible to interference effects. At the end of the procedure, protamine is given to reverse eventual residual heparin effect. An overdose of protamine can impair the coagulation itself. The investigators want to analyse the effect of a partial heparin reversal by ROTEM Analysis.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients undergoing transfemoral TAVI		Patients receiving 125 U/kg unfractioned heparin for periprocedural anticoagulation and 500U Protamine / 1000U Heparin at the end of the procedure

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary endpoint	Variability of the ROTEM CT(INTEM) after partial heparin reversal	Periprocedural

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Severe aortic valve Stenosis
transfemoral TAVI as best therapy option
unfractioned heparin for periprocedural anticoagulation

Exclusion Criteria:

known hypersensitivity /allergy to unfractioned heparin or protamine
acute systemic infection
pre procedural started and ongoing intravenous therapy with unfractioned heparin
severe periprocedural adverse event with the need for emergency surgery (with or with our CPB)
refusal of the patient to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with severe aortic valve stenosis undergoing transfemoral TAVI as best option

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patrick Mayr, MD	Contact	+498912180		mayrp@dhm.mhn.de
Michael Joner, Prof	Contact	+498912180		joner@dhm.mhn.de

Overall Officials

Name	Affiliation	Role
Patrick Mayr	Deutsches Herzzentrum München	Principal Investigator
Michael Joner	Deutsches Herzzentrum München	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München		Munich	Bavaria	D80636	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001024	Aortic Valve Stenosis

Ancestor Terms

ID	Term
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided