Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Control Intervention1: Nil: Nil
Sponsors
Meril Medical Innovations Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pediatric and adult participants of any gender aged 2-60 years. 2. Pediatric (More than 15 kg body weight): Normal Pulmonary Pressure. 3. Adults: Reversible Pulmonary Hypertension. 4. Hemodynamically significant ASD with defect size more than 8 mm. 5. Adequate margins suitable for device occlusion. 6. Participants requiring percutaneous, transcatheter closure for occlusion of an atrial septal defect (ASD) in the secundum position. 7. Participants who have undergone a fenestrated Fontan procedure and now require closure of the fenestration. 8. Participants showing echocardiographic evidence of ostium secundum ASD or clinical evidence of right ventricular (RV) volume overload (i.e., left-to-right shunt ratio of more than or equal to 1.5:1 or RV enlargement). 9. Participant is judged by the implanting physician to have adequate septal rims to retain the study device. 10. Participant can accommodate TEE or intracardiac echocardiography (ICE) probe for implant procedure. 11. Participant whose vasculature can accommodate the delivery system and procedural accessories and must have the ability to undergo procedural imaging and follow-up. 12. Participants who are able, and willing to provide voluntary, written informed consent to participate in this post-market clinical follow-up (PMCF) study.
Exclusion criteria
Exclusion criteria: 1. Participants who are unwilling to enroll in the study. 2. Participants judged to be inappropriate for enrolment in the study for any reason by the investigator. 3. Participant who has significant known pre-existing electrophysiologic or structural cardiovascular defect, or other comorbidities that could elevate morbidity or mortality beyond what is common for ASD or would require surgical treatment within three (3) years of device placement. Examples include, but are not limited to, large ventricular septal defect, hypoplastic left heart syndrome, coarctation, univentricular heart or tricuspid atresia, pulmonary hypertension, coronary artery disease, valvular or myocardial dysfunction, and other congenital heart disease requiring surgical repair. 4. Participant has systemic or inherited conditions that would significantly increase risk of major morbidity and mortality during the term of the study. Examples include endocarditis, cancer, degenerative neuromuscular disorder, cardiomyopathy, and any condition expected to result in significant deterioration of health within three (3) years of the index procedure. 5. Participant who has anatomy where the size or position of the Occluder would interfere with other intracardiac or intra vasculature structures, such as cardiac valves or pulmonary veins. 6. Participant who has active endocarditis, other infections producing bacteremia, or has known sepsis within one month of planned implantation, or any other infection that cannot be treated successfully prior to device placement. 7. Participant who has an uncontrolled arrhythmia with evidence of arrhythmia control failure within the past 90 days (e.g., supraventricular tachycardia while under rate control or atrial fibrillation while under rhythm control) or requires electrophysiology study or concomitant intervention with device placement. 8. Participant is awaiting a procedure that requires trans-septal left atrial access within 6 months of implant procedure. 9. Participant has a history of stroke resulting in a significant morbidity or disability. 10. Any participant known to have a bleeding disorder, an untreated ulcer, or any other contraindications to Aspirin therapy, unless another antiplatelet agent can be administered for 6 months. 11. Any participant known to have an extensive congenital cardiac anomaly that can only be adequately repaired by way of cardiac surgery. 12. Any participant whose size (i.e., too small for TEE probe, catheter size, etc.) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization. 13. Any participant where the margins of the defect are less than 5 mm to the coronary sinus, AV valves, or right upper lobe pulmonary vein. 14. Participant has contraindication to antiplatelet and anticoagulant medications. 15. Participant has elevated pulmonary vascular resistance (PVR) which in the opinion of the implanting physician precludes safe defect closure. 16. Participant has multiple defects based on screening imaging and stop-flow balloon sizing that would require placement of more than one device. 17. Participants in whom transesophageal echocardiography is contraindicated or in whom screening transesophageal echocardiography is unsuccessful. 18. Participants showing Echocardiographic evidence of an intracardiac mass, thrombus, or vegetation <br/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Implant Success 2. Transcatheter Closure Success. 3. Composite Clinical SuccessTimepoint: 1. Time Frame: Intra-operative 2. Time Frame: Through Discharge, 30 days, 3 months, 6 months and 1 year. 3. Time Frame: Intra-operative, Through Discharge, 30 days, 3 months, 6 months, 1 year and 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Transcatheter Closure Success. 2. Residual Shunt Assessment. 3. Device-related Adverse Events. 4. Procedural Time 5. Length of Hospital Stay 6. Clinically Significant New Arrhythmia (CSNA) 7. Changes in Cardiac Function 8. Wire Frame Fracture (WFF) 9. Procedural Success 10. Quality of Life 11. Ease of use 12. Electrocardiogram (ECG) 13. Echocardiography (ECHO) 14. Laboratory Measurement 15. Chest X-rayTimepoint: 1. Time Frame: 2 years. 2. Time Frame: Through Discharge, 30 days, 3 months, 6 months, 1 year and 2 years. 3.Time Frame: Through Discharge, 30 days, 3 months, 6 months, 1 year and 2 years. 4. Time Frame: Intra-operative 5. Time Frame: Through Discharge 6. Time Frame: Through 30 days 7. Time Frame: Baseline, Through Discharge, 30 days, 3 months, 6 months, 1 year and 2 years. 8. Time Frame: 6 months, 1 year and 2 years. 9. Time Frame: Intra-operative 10. Time Frame: Baseline, 30 days, 3 months, 6 months, 1 year and 2 years. 11. Time Frame: Intra-operative 12. Time Frame: Baseline, Through Discharge, 30 days, 3 months, 6 months, 1 year and 2 years. 13. Time Frame: Baseline, Through Discharge, 30 days, 3 months, 6 months, 1 year and 2 years. 14.Time Frame: Baseline, 30 days, 3 months, 6 months, 1 year and 2 years 15. Time Frame: Through Discharge and 1 year | — |
Countries
India
Contacts
Public ContactDr Kiran Kumar Shetty
Meril Medical Innovations Private Limited.
Outcome results
None listed