Assessments of Thrombus Formation in TAVI

NCT03248232 | Completed

• 1 other identifier: Ethics No. 1440
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Transcatheter aortic valve implantation (TAVI) is well established, and can improve clinical outcomes of patients with severe aortic valve stenosis (AS) who are inoperable or have high surgical risk. Although the rates of periprocedural bleeding events are lower in TAVI compared to those in surgical aortic valve replacement, those in TAVI still remains high. In addition, current guideline recommended the dual antiplatelet (DAPT), clopidogrel plus aspirin, for a 3- to 6-month period after TAVI, however no evidences supports this approach. The antithrombotic regimen in patients undergoing TAVI is needed to be established. To establish the antithrombotic regimen in patients undergoing TAVI,

1. 1.the investigators assess the changes in platelet thrombus formation and white thrombus formation in patients undergoing TAVI measured by Total Thrombus Formation Analysis System (T-TAS).
2. 2.the investigators analyze plasma microRNAs, and shear stress by using computational fluid dynamics (CFD) to clarify the mechanistic factors regarding those changes.

Conditions

Aortic Valve Stenosis; Heart Valve Diseases

Keywords

Transcatheter aortic valve implantation

Outcome Measures

Primary Outcomes (1)

• Changes in T-TAS parameters (AR-chip, PL-chip) during TAVI

  To measure the thrombus formation area under the curve for AR-chip (AR10-AUC30), and PL-chip (PL24-AUC10) before and after TAVI.

  pre-, day 2, day 7, 1 month after device implantation

Secondary Outcomes (3)

• Changes in shear stress analyzed by using CFD analysis of contrast-enhanced CT

  pre-, day 7 after device implantation

• Changes in von Willebrand factor multimer decrease

  pre-, day 2 after device implantation

• Periprocedural complication, particularly, bleeding complication defined by VARC-2 criteria.

  within 30 days after device implantation

Other Outcomes (1)

• Changes in plasma microRNAs

  pre-, day 2 after device implantation

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe symptomatic aortic valve stenosis, undergoing transcatheter aortic valve implantation

You may qualify if:

• twenty years and older
• with the informed consent of the patient or support person in case of disability at baseline (patient intubated and ventilated)

You may not qualify if:

• withdrawn the informed consent
• patients with trans-apical approach
• critical illness condition (severe infectious disease, cancer, severe bleeding disorder)
• transition to the surgical AVR

Sponsors & Collaborators

• Kumamoto University: lead

Study Sites (1)

Kumamoto University Hospital

Kumamoto, 860-8556, Japan

Location

Related Publications (1)

• Ishii M, Kaikita K, Mitsuse T, Nakanishi N, Oimatsu Y, Yamashita T, Nagamatsu S, Tabata N, Fujisue K, Sueta D, Takashio S, Arima Y, Sakamoto K, Yamamoto E, Tsujita K. Reduction in thrombogenic activity and thrombocytopenia after transcatheter aortic valve implantation - The ATTRACTIVE-TTAS study. Int J Cardiol Heart Vasc. 2019 Mar 28;23:100346. doi: 10.1016/j.ijcha.2019.100346. eCollection 2019 Jun.

  PMID: 30976651 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiovascular Medicine, Principal Investigator

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 14, 2017
• Study Start: August 1, 2017
• Primary Completion: April 30, 2018
• Study Completion: June 30, 2018
• Last Updated: October 2, 2018

Record last verified: 2018-09

Locations

JP (1)