Health Condition 1: null- TOF with Pulmonary Atresia, DORV with Pulmonary Atresia , TOF with Absent Pulmonary Valve, TOF requiring pulmonary valve replacement, Truncus Arteriosus, Ross procedure
Conditions
Interventions
Intervention1: Tissue Engineered Xenograft (Tissue Engineered Bovine Pericardium, Tissue Engineered Bovine Jugular Vein, Tissue Engineered Porcine Pulmonary Artery: The products can be compared with M
Sponsors
Frontier Lifeline Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1.TOF with pulmonary Atresia 2.DORV with pulmonary Atresia 3.Reoperations for patients operated for TOF requiring pulmonary valve replacement 4.Truncus Arteriosus 5.TOF with Absent pulmonary valve 6.Ross procedure (RVOT reconstruction)
Exclusion criteria
Exclusion criteria: • Subjects, who already has a implanted xenograft • Subjects on tube feedings. • Subjects using immunotherapy, or cytotoxic chemotherapy within 60 days before enrollment. Systemic steroids 30 days prior to enrollment. Topical therapy other than steroidal upto 7 days prior to enrollment. • Subjects who are HIV, HBV, HCV positive. • Subjects with hepatic, renal, or metabolic disease that is likely to interfere with the subjectâ??s participation in or completion of the study. • Subjects having any condition that would interfere with xenografting (e.g.: connective tissue disorder, immune disorder and clinical obesity). • Subjects who are malnourished. • Subjects with known hypersensitivity reactions. • Subjects who currently smoke, alcohol or any addiction. • Subjects who have participated in any other clinical study, 3 months prior to this trial. • Subjects who are unwilling or unable to comply with the study procedures. • Subjects who are considered to be unsuitable candidates by the investigator, for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of SARs (serious adverse reactions) [ Time Frame: up to 24 months ] [ Designated as safety issue: Yes ] Cardiovascular Adverse Reactions; Serious Adverse Reactions, such as infections, immunological reactions, etc. Freedom from valve dysfunction [ Time Frame: up to 24 months ] [ Designated as safety issue: No ] Freedom from valve dysfunction leading to re-intervention or explantation at end of the study. Timepoint: Amount of SARs (serious adverse reactions) [ Time Frame: up to 24 months ] [ Designated as safety issue: Yes ] Cardiovascular Adverse Reactions; Serious Adverse Reactions, such as infections, immunological reactions, etc. Freedom from valve dysfunction [ Time Frame: up to 24 months ] [ Designated as safety issue: No ] Freedom from valve dysfunction leading to re-intervention or explantation at end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood Parameters Blood Parameters as additional safety data to support presence/absence of Adverse Reactions Diameters of conduits at end of the study Diameters of conduits at end of the study in comparison to diameters at implantation Time to reoperation Valve competence assessed by noninvasive imaging tools such as echocardiography or cardiac magnetic resonance imaging Timepoint: Blood Parameters [ Time Frame: up to 24 months ] Diameters of conduits at end of the study [ Time Frame: after 24 months ] Diameters of conduits at end of the study in comparison to diameters at implantation Time to reoperation [ Time Frame: up to to 24 months ] Time to reoperation due to explantation Time to death [ Time Frame: up to 24 months ] Time to death Evaluation of transvalvular gradients [ Time Frame: up to 24 months ] | — |
Countries
India
Contacts
Public ContactDrKMCherian
Frontier Lifeline Hospital
Outcome results
None listed