UMIN-CTR Clinical Trial

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

severe aortic stenosis

Classification by specialty

Anesthesiology

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Identification of factors which predict hemodynamic compromise after rapid pacing for valve delployment during TAVI

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

08

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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% .

Registered date

2014

Year

08

Month

09

Day

Last modified on

2014

Year

08

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017216