ALTERRA Post-Approval Study

Status Recruiting

Clinical Trial Summary

This study will monitor device performance and outcomes in subjects undergoing implantation of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent in the post-approval setting

Clinical Trial Description

This is a single arm, prospective, multicenter post-approval study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05378386
Study type	Observational
Source	Edwards Lifesciences
Contact	Edwards THV Clinical Affairs
Phone	949-250-2500
Email	THV_CT.gov@Edwards.com
Status	Recruiting
Phase
Start date	May 12, 2022
Completion date	December 2034

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02534792` - Early Revalvulation After Fallot Repair Improves Clinical Outcome	N/A
Completed	`NCT00536432` - Early Re-intervention in Infants and Small Children After Correction of Tetralogy of Fallot	N/A
Not yet recruiting	`NCT05485545` - Asynchrony in Operated Tetralogy of Fallot	N/A
Completed	`NCT01941576` - Effects of rhBNP in Pediatrics After Corrective Repair of Tetralogy Of Fallot	N/A
Active, not recruiting	`NCT03983512` - PULSTA Transcatheter Pulmonary Valve Pre-Approval Study	N/A
Recruiting	`NCT04581668` - Impact of NAVA Ventilation on Brain Oxygenation and Perfusion in Children With Congenital Heart Disease	N/A
Completed	`NCT01762124` - Study of the Native Outflow Tract Transcatheter Pulmonary Valve (TPV)	N/A
Active, not recruiting	`NCT02161471` - Haemodynamics and Function of the Atria in Congenital Heart Disease by Cardiovascular Magnetic Resonance
Not yet recruiting	`NCT05916976` - Repaired Tetralogy of Fallot: Risc Score From MRI & Clinical Data to Predict the Need for Change of Treatment	N/A
Recruiting	`NCT04106479` - NIRS in Congenital Heart Defects - Correlation With Echocardiography
Completed	`NCT05579964` - The Role of Dexmedetomidine as Myocardial Protector in Pediatric Cardiac Surgery Total Correction of Tetralogy of Fallot	Phase 2/Phase 3
Recruiting	`NCT05236153` - Electroanatomic Interactions Between Transcatheter Pulmonary Valve Prostheses and Anatomic Isthmuses in Repaired Tetralogy of Fallot	N/A
Recruiting	`NCT03049995` - Stress Echo 2020 - The International Stress Echo Study
Completed	`NCT02586740` - Retrospective Review of Anesthetic Considerations for Pulmonary Artery Rehabilitation	N/A
Terminated	`NCT00564993` - Cardiac Function Under Stress for Early Detection of the Right Ventricular Insufficiency After Repair of Tetralogy of Fallot	Phase 3
Recruiting	`NCT05122962` - Pathophysiologic Mechanism for Arrhythmias and Impaired Aerobic Capacity in Tetralogy of Fallot and Other Congenital Heart Diseases
Completed	`NCT06097377` - Lymphatic Magnetic Resonance Imaging Abnormalities in Children With Tetralogy of Fallot: A Case-Control Study
Completed	`NCT03835494` - Analysis of RV-Dysfunction in Fallot Patients	N/A
Not yet recruiting	`NCT03275844` - Physical Capacity and Activity in Children With Congenital Heart Disease	N/A
Recruiting	`NCT02590679` - Multi-center Trial of Percutaneous Pulmonary Valve Implantation With Venus-p	Phase 2/Phase 3