UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051896 |
|---|---|
| Receipt number | R000059164 |
| Scientific Title | Clinical Trial to Evaluate the Efficacy and Safety of an Algorithm to Determine the Optimal Valve Placement Position during Transcatheter Aortic Valve Implantation Using the Self-Expanding Valve Evolut FX |
| Date of disclosure of the study information | 2023/09/09 |
| Last modified on | 2023/09/17 10:04:52 |
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Basic information
Public title
Clinical Trial to Evaluate the Efficacy and Safety of an Algorithm to Determine the Optimal Valve Placement Position during Transcatheter Aortic Valve Implantation Using the Self-Expanding Valve Evolut FX
Acronym
Clinical Trial to Evaluate the Efficacy and Safety of an Algorithm to Determine the Optimal Valve Placement Position during Transcatheter Aortic Valve Implantation Using the Self-Expanding Valve Evolut FX
Scientific Title
Clinical Trial to Evaluate the Efficacy and Safety of an Algorithm to Determine the Optimal Valve Placement Position during Transcatheter Aortic Valve Implantation Using the Self-Expanding Valve Evolut FX
Scientific Title:Acronym
Clinical Trial to Evaluate the Efficacy and Safety of an Algorithm to Determine the Optimal Valve Placement Position during Transcatheter Aortic Valve Implantation Using the Self-Expanding Valve Evolut FX
Region
| Japan |
Condition
Condition
severe aortic stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to prospectively evaluate the efficacy and safety of newly proposed algorithm for determining the patient-specific valve implantation depth and delivery cagtheter rotation angle in TAVI for patients with severe aortic stenosis.
Basic objectives2
Others
Basic objectives -Others
The aim of this study was to prospectively evaluate the efficacy and safety of newly proposed algorithm for determining the patient-specific valve implantation depth and delivery cagtheter rotation angle in TAVI for patients with severe aortic stenosis.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1)Coronary access after TAVI or risk of sinus sequestration in TAVI-in-TAVI as assessed by post-TAVI CT
2)Rate of permanent pacemaker implantation at 30 days after TAVI or incidence of new left bundle branch block on ECG at discharge after TAVI
Key secondary outcomes
1)Percentage of success in TAVI implantation at a position preoperatively pre-defined by PODCAST approach
2)Number of recaptures during implantation of the TAVI valve
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The aim of this study was to prospectively evaluate the efficacy and safety of newly proposed algorithm for determining the patient-specific valve implantation depth and delivery cagtheter rotation angle in TAVI for patients with severe aortic stenosis.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Severe aortic stenosis with New York Heart Association (NYHA) grade 2 or higher
2)Patients indicated for TAVI based on the guidelines for the treatment of valvular disease in Japan as a result of consultation in the Heart Team at each site
3)Subjects who were judged to be anatomically suitable for TAVI via the femoral approach with Evolut FX system by preoperative computed tomography at the consultation in the heart team of each site.
4)Subjects who gave written informed consent on their own free will after receiving sufficient explanation for participation in this study
Key exclusion criteria
1)Study subjects with low quality of preoperative CT
2)Prior pacemaker or ICD implantation
3)Prior prosthetic valve implantation in the aortic position
4)Patients with bicuspid aortic valve
5)Contraindications for implantation of bioprosthetic valves
6)Patients with allergy, hypersensitivity or contraindication to any of the following
Aspirin or heparin, Ticlopidine and clopidogrel, Nitinol (titanium or nickel), Contrast medium
7)Patients with preoperative renal impairment (eGFR <30 ml/min/1.73m2), or patients on chronic dialysis
8)Patients with left ventricular ejection fraction <30% as measured by preoperative transthoracic cardiac ultrasound.
9)Patients with NYHA IV decompensated heart failure
10)Patients receiving hemodynamic support with circulatory assist devices for cardiogenic shock
11)Persistent sepsis, including active endocarditis
12)Patients with left ventricular thrombus
13)Anatomically unsuitable for TAVI via the femoral approach
14)Patients for whom surgical valvular surgery is indicated by the Heart Team
15)Having any of the following hematologic disorders: leukopenia (white blood cell count < 1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3).
16)Patients who are pregnant or breastfeeding
17)Currently participating in other clinical trials (excluding registry studies) of investigational drugs or other devices
18)Severe dementia (leading to an inability to receive an explanation for consent for the procedure or difficulty in a follow-up visit after the procedure)
19)Life expectancy is less than 12 months due to non-cardiac comorbidities
20)Patients who have difficulty agreeing on their own will due to cognitive decline
21)Other patients considered by the Principal Investigator to be inappropriate as study subjects
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tomoki |
| Middle name | |
| Last name | Ochiai |
Organization
Shonan Kamakura General Hospital
Division name
Department of Cardiology
Zip code
2478533
Address
1370-1, Okamoto, Kamakura, Kanagawa 2478533, JAPAN
TEL
0467461717
tomoki.ochiai.0307@gmail.com
Public contact
Name of contact person
| 1st name | Tomoki |
| Middle name | |
| Last name | Ochiai |
Organization
Shonan Kamakura General Hospital
Division name
Department of Cardiology
Zip code
2478533
Address
1370-1, Okamoto, Kamakura, Kanagawa 2478533, JAPAN
TEL
0467461717
Homepage URL
tomoki.ochiai.0307@gmail.com
Sponsor or person
Institute
Shonan Kamakura General Hospital
Institute
Department
Personal name
Tomoki Ochiai
Funding Source
Organization
Shonan Kamakura General Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
Medtronic
IRB Contact (For public release)
Organization
The Tokushukai Group Ethics Committee
Address
Emina Building 3F, 1-8-7, Koji-machi, Chiyoda-ku, Tokyo, JAPAN
Tel
0332634801
mirai-ec1@mirai-iryo.com
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
湘南鎌倉総合病院（神奈川県）
札幌東徳洲会病院（北海道）
岸和田徳洲会病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 11 | Day |
Last modified on
| 2023 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059164
