UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047888 |
|---|---|
| Receipt number | R000054582 |
| Scientific Title | Transcatheter closure of secundum atrial septal defect using Cocoon Septal Occluder:- Immediate and long term results |
| Date of disclosure of the study information | 2022/05/29 |
| Last modified on | 2022/06/09 04:11:17 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Transcatheter closure of secundum atrial septal defect using Cocoon Septal Occluder:- Immediate and long term results
Acronym
Transcatheter closure of secundum atrial septal defect using Cocoon Septal Occluder:- Immediate and long term results
Scientific Title
Transcatheter closure of secundum atrial septal defect using Cocoon Septal Occluder:- Immediate and long term results
Scientific Title:Acronym
Transcatheter closure of secundum atrial septal defect using Cocoon Septal Occluder:- Immediate and long term results
Region
| Asia(except Japan) |
Condition
Condition
Atrial septal Defect
Classification by specialty
| Cardiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate feasibility, effectiveness, safety, and long term outcome of transcatheter closure (TCC) of atrial septal defect (ASD) using Cocoon septal occluder.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy: successful closure of defect without significant shunt (not more than mild) on six months of follow-up.
Saftey: successful deployment without either major peri-procedural complications (death, device embolization, cardiac perforation, pericardial effusion, stroke, infective endocarditis, atrioventricular block) or late embolization, erosion, and residual shunting on follow up.
Key secondary outcomes
Death, device embolization, cardiac perforation, pericardial effusion, stroke, infective endocarditis, atrioventricular block, late embolization, erosion, and residual shunting.
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Transcatheter closure of secundum atrial septal defect using Cocoon Septal Occluder (Vascular Innovation, Thailand)
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
| 4 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with atrial septal defect more than 4 year old with
1, echocardiographic evidence of right ventricular volume overload.
2, significant left to right shunt
3,maximum diameter of ASD less than 40 mm with adequate rims.
Key exclusion criteria
Aanomalous pulmonary venous connection,
Associated complex cardiac anomaly,
Eisenmenger syndrome,
Impaired left ventricular systolic function, and
Inadequate (<4mm) inferior vena cava (IVC) rim
Target sample size
320
Research contact person
Name of lead principal investigator
| 1st name | Santosh |
| Middle name | Kumar |
| Last name | Sinha |
Organization
LPS Institute of Cardiology
Division name
Department of Cardiology
Zip code
208002
Address
D 17, Medical College Campus, GSVM, Swaroop Nagar
TEL
00917042132737
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
0091-7042132737
Homepage URL
sofinajeeb@gmail.com
Sponsor or person
Institute
LPS Institute of Cardiology
Department of Cardiology
Institute
Department
Personal name
Funding Source
Organization
LPS Institute of Cardiology
Department of Cardiology
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
Institutional Ethical Committee, LPS institute of Cardiology
Address
GT Road, Swaroop Nagar, Kanpur, UP, India 208002
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
320
Results
Efficacy 312(97.5%)
Safety 312(97.5%)
Mean Procedural time (mins) 23.5
Mean Fluoroscopy time (mins) 6.8
Periprocedural complications 27 (8.4%)
Cardiac death 0 (0%)
Device embolization 2 (0.6%)
Cardiac perforation 1 (0.3%)
Pericardial effusion 3 (0.9%)
Transient supraventricular arrhythmias 15 (4.6%)
Transient atrioventricular block 6 (1.8%)
Local site hematoma 0 (0%)
Stroke 0 (0%)
Transient headache 8 (2.5%)
Closure rate 312 (100%)
Late embolization 0 (0%)
Erosion 0(0%)
Residual shunting 2 (0.6%)
Results date posted
| 2022 | Year | 05 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Sex (Female/Male) 238(74%)/82(26%)
Age (years) 14.6 (6-29)
Clinical Indications
a. Right ventricular overload 320(100%)
b. Failure to thrive 81(25.3%)
c. Recurrent respiratory tract infection 73(22.8%)
d. Exrecise intolerance 57(17.%)
e. Pulmonary hypertension 13(4.1%)
f. Palpitation 9(2.8%)
Rhythm
a. Sinus rhythm 313(97.8%)
b. Atrial fibrillation (AFib) 5(1.5%)
Deficient rims (<5mm) 52(16.2%)
a. Posterior 14(4.3%)
b. Aortic 33(10.3%)
c. Superior 5(1.2%)
d. Inferior 0(0)
Absent aortic rim 11(3.4%)
Weight (kg) 30.2 (10-53)
Pulmonary vs. systemic flow (Qp/Qs) 2.6(1.4-3.6)
Associated disease 7(2.1%)
a. Rheumatic mitral stenosis 2(0.6%)
b. Patent ductus arteriosus (PDA) 3(0.9)
c. Ventricular septal defect (VSD) 2(0.6%)
Normal Situs solitus 317(99%)
Situs inversus 3(1%)
Follow up duration (months) 50.92 (12.5-89)
Hospital stay (hours) 29.4
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 13 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 13 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 29 | Day |
Last modified on
| 2022 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054582
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
