UMIN-CTR Clinical Trial

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
Email	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
Email	sofinajeeb@gmail.com

Sponsor
Institute	LPS Institute of Cardiology Department of Cardiology
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054582