Clinical trial NCT03248232: Assessments of Thrombus Formation in TAVI
Official title: AssessmenTs of ThRombogenicity for trAnsCatheter aorTIc valVE Implantation by Total Thrombus-formation Analysis System (ATTRACTIVE-TTAS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Heart Valve Diseases
Keywords: Transcatheter aortic valve implantation
Lead sponsor: Kumamoto University
Sponsor class: OTHER
First posted: 2017-08-14
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe symptomatic aortic valve stenosis, undergoing transcatheter aortic valve implantation

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. 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. the investigators analyze plasma microRNAs, and shear stress by using computational fluid dynamics (CFD) to clarify the mechanistic factors regarding those changes.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* withdrawn the informed consent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

Primary outcomes:
measure: Changes in T-TAS parameters (AR-chip, PL-chip) during TAVI
timeFrame: pre-, day 2, day 7, 1 month after device implantation
Secondary outcomes:
measure: Changes in shear stress analyzed by using CFD analysis of contrast-enhanced CT
timeFrame: pre-, day 7 after device implantation
measure: Changes in von Willebrand factor multimer decrease
timeFrame: pre-, day 2 after device implantation
measure: Periprocedural complication, particularly, bleeding complication defined by VARC-2 criteria.
timeFrame: within 30 days after device implantation
Other outcomes:
measure: Changes in plasma microRNAs
timeFrame: pre-, day 2 after device implantation
Locations:
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
Study officials:
References:
citation: 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.