Aortic Valve StenosisNCT03248232
Assessments of Thrombus Formation in TAVI
An observational study of Aortic Valve Stenosis and Heart Valve Diseases, run by Kumamoto University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Aortic Valve Stenosis, Heart Valve Diseases
- How many people
- 23 participants
- Where
- 1 siteJapan
- Study dates
- 1 Aug 2017to 30 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe symptomatic aortic valve stenosis, undergoing transcatheter aortic valve implantation
Who may be able to join
- twenty years and older
- with the informed consent of the patient or support person in case of disability at baseline (patient intubated and ventilated)
Who cannot join
- withdrawn the informed consent
- patients with trans-apical approach
- critical illness condition (severe infectious disease, cancer, severe bleeding disorder)
- transition to the surgical AVR
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AssessmenTs of ThRombogenicity for trAnsCatheter aorTIc valVE Implantation by Total Thrombus-formation Analysis System (ATTRACTIVE-TTAS)
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,
- 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).
- 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
- Medical subject headings
- Aortic Valve Stenosis, Heart Valve Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
To measure the shear stress of aortic valve and aorta before and after TAVI by using CFD analysis of contrast-enhanced computed tomography (CT).
Measured: pre-, day 7 after device implantation
Changes in von Willebrand factor multimer decrease
To measure the von Willebrand factor multimer decrease by using electrophoresis
Measured: pre-, day 2 after device implantation
Periprocedural complication, particularly, bleeding complication defined by VARC-2 criteria.
Measured: within 30 days after device implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start1 Aug 2017
- Primary completion30 Apr 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kumamoto University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenichi Tsujita, MD, PhD, Kumamoto University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248232
- Sponsor's protocol ID
- Ethics No. 1440
- Status last verified
- Sep 2018
- First submitted
- 9 Aug 2017
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30976651
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AssessmenTs of ThRombogenicity for trAnsCatheter aorTIc valVE Implantation by Total Thrombus-formation Analysis System (ATTRACTIVE-TTAS)
- ClinicalTrials.gov ID
- NCT03248232
- Acronym / sponsor ID
- Ethics No. 1440
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases
- Keywords
- Transcatheter aortic valve implantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Kumamoto UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 14 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,
- 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).
- the investigators analyze plasma microRNAs, and shear stress by using computational fluid dynamics (CFD) to clarify the mechanistic factors regarding those changes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe symptomatic aortic valve stenosis, undergoing transcatheter aortic valve implantation
Key inclusion criteria (2 listed)
- twenty years and older
- with the informed consent of the patient or support person in case of disability at baseline (patient intubated and ventilated)
Key exclusion criteria (4 listed)
- withdrawn the informed consent
- patients with trans-apical approach
- critical illness condition (severe infectious disease, cancer, severe bleeding disorder)
- transition to the surgical AVR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in T-TAS parameters (AR-chip, PL-chip) during TAVI
Time frame: pre-, day 2, day 7, 1 month after device implantation
To measure the thrombus formation area under the curve for AR-chip (AR10-AUC30), and PL-chip (PL24-AUC10) before and after TAVI.
3 secondary outcomes
Changes in shear stress analyzed by using CFD analysis of contrast-enhanced CT
Time frame: pre-, day 7 after device implantation
Changes in von Willebrand factor multimer decrease
Time frame: pre-, day 2 after device implantation
Periprocedural complication, particularly, bleeding complication defined by VARC-2 criteria.
Time frame: within 30 days after device implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Derived from this study: PubMed 30976651Ishii 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis and Heart Valve Diseases, run by Kumamoto University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in T-TAS parameters (AR-chip, PL-chip) during TAVI (time frame: pre-, day 2, day 7, 1 month after device implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03248232, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018.