Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Nil: Nil
Control Intervention1: Nil: Nil
Sponsors
Meril Medical Innovations Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants aged more than 6 months at the time of PDA Occluder implantation. 2. Participants parents or guardians must be willing and able to provide written Informed Consent by signing and dating the IRB or EC-approved Informed Consent Form. 3. The participants should be able to comply with protocol requirements and assessments. 4. Participants diagnosis with PDA. 5. Participants with normal pulmonary pressure. 6. Participants with adequate margins for device occlusion. 7. PDA morphology and size are suitable for transcatheter closure using the FLORET PDA Occluder System. 8. Participants with pulmonary vascular resistance of lessthan or equal to 8 Wood units and Rp or Rs ratio less than or equal to 0.4. 9. Participants must not be participating in another study for an investigational drug and,or device
Exclusion criteria
Exclusion criteria: 1. Participants with complex congenital heart disease. 2. Participants weighing less than 6 kilograms. 3. Participants aged 18 years or older. 4. Participants with coexisting congenital heart disease that requires surgical correction. 5. Participants with Patent Ductus Arteriosus dependent heart defects. 6. Participants with Patent Ductus Arteriosus and irreversible elevated pulmonary vascular resistance that is unresponsive to oxygen testing. 7. Participants with severe pulmonary hypertension featuring right to left shunting through the Patent Ductus Arteriosus, where systemic cardiac output depends on the shunt. 8. Participants with active endocarditis or any other systemic infection associated with bacteremia at the time of implantation. 9. Participants with inadequate vasculature to accommodate the required sheath size for access to the defect. 10. Participants with the presence of thrombus at the intended implant site, or documented evidence of venous thrombus in the vessels through which access to the defect is obtained. 11. Participants with a contraindication to anticoagulation treatment. 12. Participants with known bleeding disorders or ongoing anticoagulant therapy that cannot be temporarily discontinued for the procedure. 13. Participants with known hypersensitivity or allergy to nickel that may lead to an allergic reaction to the device. 14. Participants with pulmonary hypertension, defined as pulmonary vascular resistance less than 8 Wood units or a pulmonary to systemic vascular resistance ratio greater than 0.4.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Successful PDA Closure 2. Clinical Closure 3. Acute Procedure Success 4. Composite Success 5. Complications and Adverse/Serious Adverse EventsTimepoint: 1. Time Frame: Intraoperative 2.Time Frame: Through Discharge, 1 month, 3 months, 6 months, 1 year and 2 years. 3. Time Frame: Intraoperative 4. Time Frame: Through Discharge, 1 monts, 3 months, 6 months and 1 year. 5. Time Frame Intraoperative, Through Discharge, 1 month, 3 months, 6 months, 1 year and 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Composite Success 2. Procedure Time 3. Left Pulmonary Artery (LPA) Obstruction 4. Thoracic Aorta Obstruction 5. Mean Pulmonary Artery Pressure (mPAP) 6. Air Kerma 7. Dose Area Product (DAP) 8. NYHA Classification 9. Contrast induced Kidney Injury 10. Survival 11. Length of Hospital Stay 12. Ease of Use 13. Readmission Rate 14. Echocardiography (ECHO) 15. Electrocardiogram (ECG) 16. Chest X-rayTimepoint: 1. Time Frame: 2 years. 2. Time Frame: Intraoperative 3. Time Frame: Baseline, Intraoperative, Through Discharge, 1 month, 3 months, 6 months, 1 year, 2 years 4. Time Frame: Baseline, Intraoperative, Through Discharge, 1 month, 3 months, 6 months, 1 year, 2 years. 5. Time Frame: Baseline, Intraoperative, Through Discharge , 1 month, 3 months, 6 months, 1 year, 2 years. 6. Time Frame: Intraoperative 7. Time Frame: Intraoperative 8. Time Frame: Baseline, Intraoperative, Through Discharge , 1 month, 3 months, 6 months, 1 year, 2 years 9. Time Frame: Through Discharge, 1 month 10.Time Frame: Baseline, Intraoperative, Through Discharge , 1 month, 3 months, 6 months, 1 year, 2 years 11. Time Frame: Through Discharge 12. Time Frame: Intraoperative 13. Time Frame: Baseline, Intraoperative, Through Discharge , 1 month, 3 months, 6 months, 1 year, 2 years 14. Time Frame: Baseline, Intraoperative, Through Discharge , 1 month, 3 months, 6 months, 1 year, 2 years 15. Time Frame: Baseline, Intraoperative, Through Discharge , 1 month, 3 months, 6 months, 1 year, 2 years 16. Time Frame: Through Discharge, 1 year | — |
Countries
India
Contacts
Public ContactDr Kiran Kumar Shetty
Meril Medical Innovations Private Limited.
Outcome results
None listed