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Recruitment status Completed
Unique ID issued by UMIN UMIN000014803
Receipt No. R000017216
Scientific Title Predictors of hemodynamic compromise after rapid pacing for valve deployment during transcatheter aortic valve implantation
Date of disclosure of the study information 2014/08/09
Last modified on 2014/08/09

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Basic information
Public title Predictors of hemodynamic compromise after rapid pacing for valve deployment during transcatheter aortic valve implantation
Acronym Predictors of hemodynamic compromise after rapid pacing for valve deployment during TAVI
Scientific Title Predictors of hemodynamic compromise after rapid pacing for valve deployment during transcatheter aortic valve implantation
Scientific Title:Acronym Predictors of hemodynamic compromise after rapid pacing for valve deployment during TAVI
Region
Japan

Condition
Condition severe aortic stenosis
Classification by specialty
Anesthesiology Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Although the gold standard of treatment for severe aortic stenosis (AS) is surgical aortic valve replacement (AVR), AVR has not been applicable for patients at high risk because AVR, which requires cardiopulmonary bypass (CPB) and cardiac arrest, is too invasive to such patients.
Transcatheter aortic valve implantation (TAVI) is a treatment for severe AS practically applyng catheter technique. TAVI is thought as less invasive than AVR because it does not require CPB, and is widely recognized as feasible treatment for AS patiets at high risk.
However some procedures of TAVI provoke hemodynamic unstability. The representive one is rapid pacing (RP), which causes severe hemodynamic compromise because it is induced in order to limit cardiac ejection by artificial tachycardia (160~220 beat per minute) for precise completion of valve deployment. During RP, blood pressure drops down extremely because blood flow almost stops. Althpugh hemodynamics will recover after RP, some cases suffers from hemodynamic compromise with long duration. Thus, it is important to identify factors which predicts hemidynamic compromise ofter RP, there was no report about this.
We will retrospectively observe systemic blood pressure and mixed venous oximetry (SvO2) as index of systemic oxygen balances, and then investigate the factors which influenced the recovery of blood pressure and SvO2 after RP for valve deployment.
Basic objectives2 Others
Basic objectives -Others We will identify factors, which predict hemodynamic compromise after rapid pacing for valve delployment during TAVI, from preoperative data and intraoperative hemodynamic parameters.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Identification of factors which predict hemodynamic compromise after rapid pacing for valve delployment during TAVI
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

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Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with severe AS undergoing TAVI
Key exclusion criteria Cases in which mechanical circulatory support were induced electively or emergenty during the operations
Target sample size 44

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Iritakenishi
Organization Osaka University Graduate School of Medicine
Division name Department of Anesthesiology and Intensive Care Medicine
Zip code
Address 2-2 Yamada-oka, 2-2 Suita Osaka 565-0871, Japan
TEL 06-6879-3133
Email iritake@anes.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Iritakenishi
Organization Osaka University Graduate School of Medicine
Division name Department of Anesthesiology and Intensive Care Medicine
Zip code
Address 2-2 Yamada-oka, 2-2 Suita Osaka 565-0871, Japan
TEL 06-6879-3133
Homepage URL
Email iritake@anes.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Department of Anesthesiology and Intensive Care Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Osaka University Graduate School of Medicine
Department of Anesthesiology and Intensive Care Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 09 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 04 Month 21 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Multiple logistic analysis identified only SvO2 before RP as the significantly independent factor of the delayed recovery of hemodynamics after RP . Receiver operating characteristic (ROC) curves analysis showed that two groups ware discriminated by SvO2 of 67% a sensitivity of 82% and a specificity of 85% .

Management information
Registered date
2014 Year 08 Month 09 Day
Last modified on
2014 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017216


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