Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07466745 · ClinicalTrials.gov registry record · NA
Autus Valve Continued Access Study (CAS)
A NA study, sponsored by Edwards Lifesciences.
- Not yet
- Registry status
- NA
- Development phase
- 36
- Enrollment target
NCT07466745: Clinical Trial NA study, sponsored by Edwards Lifesciences.
NCT07466745 is a NA study that has not yet begun recruiting, run by Edwards Lifesciences. The registered enrollment target is 36 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07466745, a NA study, has not yet begun recruiting, sponsored by Edwards Lifesciences.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 36 participants
- Enrollment target
Study Summary
Prospective, single-arm, multi-center, continued access study of the Autus Size-Adjustable Valve in pediatric patients aged 18 months to 16 years requiring surgical pulmonary valve replacement. The Autus Valve may be expanded pre-implant to match the subject's body size. Subjects will be evaluated prior to the Autus Valve implant procedure, immediately post-implantation, at hospital discharge, 30 days, 6 months, and annually through 10 years. The Autus Valve may be expanded post-implant via transcatheter balloon dilation to accommodate growth of the subject.
Primary Outcome
Composite Endpoint: Freedom from a device-related complication through 30 days post-valve implantation as adjudicated by an independent Clinical Events Committee (CEC), including: * Death; * Valve thrombosis requiring reintervention; * Symptomatic thromboembolism.
Interventions
- DEVICE Pulmonary Valve Replacement Surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2026-04-15 |
| Est. Completion | 2036-04-30 |
| Phase | NA |
What is known before NCT07466745 opens enrollment
NCT07466745 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Pulmonary Valve Replacement Surgery is the first listed.
NCT07466745 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07466745 about?
NCT07466745 is a clinical study titled "Autus Valve Continued Access Study (CAS)". Prospective, single-arm, multi-center, continued access study of the Autus Size-Adjustable Valve in pediatric patients aged 18 months to 16 years requiring surgical pulmonary valve replacement. The Autus Valve may be expanded pre-implant to match the subject's body size. Subjects will be evaluated p...
What is the current status of trial NCT07466745?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 36 participants. The study started on 2026-04-15. Estimated completion is 2036-04-30.
What interventions are being tested in trial NCT07466745?
The interventions under investigation include: Pulmonary Valve Replacement Surgery (DEVICE).
Who is sponsoring clinical trial NCT07466745?
This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07466745's enrollment target sits among peer trials
36 1541st of 2000 higher than 437 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00929006 · 36 participants · Early Phase 1
Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism
- NCT01891318 · 36 participants · Phase 1
Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study
- NCT02291848 · 36 participants · Phase 1
Tumor-Associated Antigen-Specific Cytotoxic T-Lymphocytes for Multiple Myeloma
- NCT02366819 · 36 participants · Phase 4
Genetic Analysis-Guided Irinotecan Hydrochloride Dosing of mFOLFIRINOX in Treating Patients With Locally Advanced Gastroesophageal or Stomach Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI