UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056540 |
|---|---|
| Receipt number | R000064612 |
| Scientific Title | Investigation of Predictive Factors for Hemodynamic Deterioration During Ventricular Arrhythmias in Patients with Left Ventricular Assist Devices |
| Date of disclosure of the study information | 2024/12/25 |
| Last modified on | 2026/01/16 13:04:27 |
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Basic information
Public title
Investigation of Predictive Factors for Hemodynamic Deterioration During Ventricular Arrhythmias in Patients with Left Ventricular Assist Devices
Acronym
LVAD-CF trial
Scientific Title
Investigation of Predictive Factors for Hemodynamic Deterioration During Ventricular Arrhythmias in Patients with Left Ventricular Assist Devices
Scientific Title:Acronym
LVAD-CF trial
Region
| Japan |
Condition
Condition
Severe heart failure with LVAD
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To perform a quantitative assessment of circulatory dynamics during VA or right ventricular pacing simulating VA and to search for factors that correlate with the change in cardiac coefficient from baseline.
Basic objectives2
Others
Basic objectives -Others
Exploring Predictors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percent change from baseline in cardiac index (CI) during VA or RV pacing
Key secondary outcomes
Deterioration in Circulation (CI Change -10, -20, -30%)
Right atrial pressure, pulmonary artery index, pulmonary vascular resistance, cardiac output, left ventricular ejection fraction, tricuspid annular systolic distance, Left ventricular end-diastolic diameter, left atrial diameter, and valvular disease severity, baseline BNP
Percent change from baseline in mixed venous oxygen saturation (SvO2) during VA or RV pacing
Percent change from baseline in mean arterial blood pressure (mAoP) during VA or RV pacing
Percent change from baseline in LVAD flow during VA or RV pacing
LVEDD, LAD, and valvular disease severity during ventricular arrhythmias or RV pacing
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
In patients in whom sustained ventricular arrhythmia could not be induced during a standard electrophysiological study, pacing at 160 bpm and 200 bpm is performed for 5 minutes each.
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
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who underwent left ventricular assist device (LVAD) implantation between January 1, 2015, and March 31, 2027, and are currently on LVAD support.
2.Patients meeting any of the following conditions and scheduled for hemodynamic evaluation via right heart catheterization:
1).Patients undergoing routine follow-up examinations (e.g., immediately post-LVAD implantation or in preparation for heart transplantation).
2).Patients experiencing frequent activation of the low-flow alarm.
3).Patients with uncontrollable systemic congestion (e.g., pleural effusion, lower extremity edema).
4).Patients with worsening valvular disease (defined as an increase in severity by at least one grade).
3.Patients with structural heart disease, left ventricular ejection fraction <40%, and documented ventricular arrhythmias.
4.Patients aged 18 years or older at the time of consent.
5.Patients who fully understand the study protocol and provide informed consent.
Key exclusion criteria
1.Patients with sustained ventricular arrhythmias.
2.Patients deemed unsuitable for the use of an EP catheter or a Swan-Ganz thermodilution catheter.
3.Patients judged by the investigator to be inappropriate as study subjects.
4.Patients who cannot provide informed consent.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Takase |
Organization
Department of Cardiovascular medicine, Kyushu University Hospital
Division name
Cardiovascular Medicine
Zip code
812-0044
Address
3-1-1, Umade, Higashi-ku, Fukuoka city, Fukuoka
TEL
092-642-5371
watanabe.tsukasa@junnai.org
Public contact
Name of contact person
| 1st name | Tsukasa |
| Middle name | |
| Last name | Watanabe |
Organization
Department of Cardiovascular medicine, Kyushu University Hospital
Division name
Cardiovascular medicine
Zip code
812-0044
Address
3-1-1, Umade, Higashi-ku, Fukuoka city, Fukuoka
TEL
092-642-5371
Homepage URL
https://www.cardiol.med.kyushu-u.ac.jp/
watanabe.tsukasa@junnai.org
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Clinical and Translational Research, Kyushu University Hospital
Address
3-1-1 Maidashi Higashi-ku Fukuoka
Tel
092-642-5082
byskenkyu@jimu.kyushu-u.ac.jp
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
九州大学病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2027 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 23 | Day |
Last modified on
| 2026 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064612
