ADAPT Transcatheter Aortic Valve Intervention (TAVI & Chronic Total Occlusion Percutaneous Coronary Intervention (CTO PCI)

NCT05259241 | Unknown

• 1 other identifier: MEC-2020-0375
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: The choice of antithrombotic regimen during TAVI and CTO PCI includes the use of unfractionated heparin. The accuracy of ACT in this setting is disputed. ACT has never been compared to a point-of-care aPTT test for monitoring anticoagulation during percutaneous cardiac interventions. Objective: The aim of the present study is to evaluate which point-of-care test (ACT or aPTT) gives the best correlation with the coagulation status in patients, defined with the anti-Xa measurement. Study design: A Single-center, prospective, observational study Study population: patients undergoing TAVI (Cohort A) or CTO PCI (Cohort B) in the Erasmus University Medical Center Main study parameters/endpoints: The main study endpoints are the correlation between the ACT and APTT point-of-care- tests and the coagulation status, defined as the laboratory anti-Xa measurement.

Conditions

Transcatheter Aortic Valve Replacement; Percutaneous Coronary Intervention

Keywords

ACT; APTT

Outcome Measures

Primary Outcomes (2)

• The correlation between the ACT point-of-care test with the Anti-Xa-activity measurement).

  The anti-Xa-measurement(in IU/mL) is defined as the reference for the coagulation status. In this study, we measure the point-of-care ACT measurement(in milliseconds) and the anti-Xa measurement 30 minutes after the heparin bolus to determine the correlation.

  30 minutes after heparin bolus

• The correlation between the APTT point-of-care test with the coagulation status(Anti-Xa-measurement).

  The anti-Xa-measurement(in IU/mL) is defined as the reference for the coagulation status. In this study, we measure the point-of-care APTT measurement(in milliseconds) and the anti-Xa measurement 30 minutes after the heparin bolus to determine the correlation.

  30 minutes after heparin bolus

Study Arms (1)

Single arm study

OTHER

Cohort A: patients undergoing TAVR to evaluate which point-of-care test (ACT or aPTT) gives the best correlation with the coagulation status Cohort B: patients undergoing PCI to evaluate which point-of-care test (ACT or aPTT) gives the best correlation with the coagulation status

Diagnostic Test: activated partial thrombin time

Interventions

activated partial thrombin time DIAGNOSTIC_TEST

This study aims to find which the point-of-care test (ACT or APTT) has the best correlation with the coagulation status during transcatheter cardiac interventions (either TAVR or PCI)

Also known as: activated clotting time

Single arm study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing a TAVI-procedure
• All patients undergoing a CTO PCI procedure

You may not qualify if:

• none

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Roche Diagnostics GmbH: collaborator

Study Sites (1)

Erasmus University Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

RECRUITING

Central Study Contacts

Nicolas Van Mieghem, MD, PhD

CONTACT

+31 10 703 52 60; n.vanmieghem@erasmusmc.nl

Thijmen Hokken, MD

CONTACT

+31107038896; t.hokken@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical director of Interventional cardiology

Model Details: Single-center, prospective, observational study

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: February 28, 2022
• Study Start: October 20, 2020
• Primary Completion: December 31, 2022
• Study Completion: January 1, 2023
• Last Updated: July 27, 2022

Record last verified: 2022-07

Locations

NL (1)