UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051063 |
|---|---|
| Receipt number | R000058226 |
| Scientific Title | Accura Balloon dilatation catheter for Percutaneous Balloon Pulmonary Valvuloplasty among Adult Patients |
| Date of disclosure of the study information | 2023/05/15 |
| Last modified on | 2023/05/15 16:36:21 |
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Basic information
Public title
Accura Balloon dilatation catheter for Percutaneous Balloon Pulmonary Valvuloplasty among Adult Patients- Its protean use
Acronym
Accura Balloon for BPV
Scientific Title
Accura Balloon dilatation catheter for Percutaneous Balloon Pulmonary Valvuloplasty among Adult Patients
Scientific Title:Acronym
Accura Balloon for BPV
Region
| Asia(except Japan) |
Condition
Condition
Pulmonary valve Stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and efficacy of the Accura balloon for Balloon Pulmonary Valvuloplasty
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Successful Balloon Pulmonary Valvuloplasty, defined as residual gradient less than 35 mm Hg and absence of any major complication like death, cardiac perforation, tamponade, and bleeding.
Key secondary outcomes
Major complications (death, cardiac perforation, tamponade, and bleeding).
Minor complications (transient hypotension, ventricular premature contraction, and transient bradycardia)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Use of Accura Balloon dilatation catheter for Percutaneous Balloon Pulmonary Valvuloplasty among Adult patients
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
asymptomatic patients with echocardiographic evidence of suitable morphology and maximum instantaneous and mean gradient across the pulmonary valve of more than 60mmHg and 40 mmHg respectively and in symptomatic patients with a maximum instantaneous gradient of more than 50mmHg and mean gradient of more than 30 mmHg.
Key exclusion criteria
associated infundibular stenosis
supravalvular stenosis
associated complex cyanotic disease requiring palliation
more than Grade III pulmonary leak
pulmonary annulus more than 15mm
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Santosh |
| Middle name | Kumar |
| Last name | Sinha |
Organization
LPS Institute of Cardiology, GSVM, Kanpur, India
Division name
Department of Cardiology
Zip code
208002
Address
Medical College Campus, GSVM, Swaroop Nagar
TEL
00919670220088
fionasan@rediffmail.com
Public contact
Name of contact person
| 1st name | Najeeb |
| Middle name | Ullah |
| Last name | Sofi |
Organization
LPS institute of Cardiology
Division name
Department of Cardiology
Zip code
208002
Address
D 17, Medical College Campus, GSVM, Swaroop Nagar
TEL
00917042132737
Homepage URL
sofinajeeb@gmail.com
Sponsor or person
Institute
LPS Institute of Cardiology
GSVM
Kanpur
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
LPS institute of Cardiology
Address
D 17, Medical College Campus, GSVM, Swaroop Nagar
Tel
0091-7042132737
sofinajeeb@gmail.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
LPS Institute of Cardiology, GSVM, Kanpur, UP, India 208002
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 15 | 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
43
Results
Successful BPV was done in all 43 patients among which 5 patients had dysplastic valve.
The mean diameter of the annulus was 18.5 mm.
Immediate hemodynamic improvement was observed in 38 patients as peak systolic gradient reduced from 84 to 22 mmHg while 5 patients had <50% reduction of resting gradient though it came down significantly at 6 months.
Fluoroscopy and procedural time were 5.2 min and 22.6 min respectively.
Results date posted
| 2023 | Year | 05 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Age (years) 21.9 (18- 29)
Sex (Male/Female) 31(72%)/12(28%)
Weight (kg) 32.7 (22.6- 381.)
Height (cm) 139.8 (123.5-157.2)
BSA 1.48 (1.32-1.72)
Clinical presentation
A. Asymtomatic 08(18.6%)
B. Symtomatic 35(81.4%)
a. Dyspnoea 28(65%)
b. Fatigue 18(41%)
c. Palpitation 13(30%)
d. Syncope 3(7%)
e. Evaluation of murmur 5(11.6%)
f. Cyanosis 2(4.5%)
PV morphology
a. Doming 38(88.4%)
b. Dysplastic 5(11.6%)
Peak echocardiographic gradient (mm Hg) 76(52-166)
RV to PA peak catheter pullback gradient (mm Hg) 68(52-159)
RV/Systemic pressure ratio 0.85(0.60-1.3)
Pulmonary annulus diameter (mm) 18.5(10-21)
Balloon/annulus ratio 1.23(1.20-1.28)
Participant flow
Adverse events
Major complications (death, cardiac perforation, tamponade, Bleeding) 0(0%)
Minor complications
a. Transient hypotension 35(81%)
b. Ventricular premature contraction 39(91%)
c. Transient bradycardia 36(84%)
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 03 | 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 | 05 | Month | 15 | Day |
Last modified on
| 2023 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058226
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