Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study

Clinical Trial Summary

This is a multi-center prospective, single-arm, non-randomized, pivotal study that will continue to access the feasibility of the Xeltis Bioabsorbable Pulmonary Valved Conduit in subjects requiring right ventricular outflow tract correction or reconstruction due to congenital heart malformations.

See also
	Status	Clinical Trial	Phase
	Recruiting	`NCT05066399` - Fetal Cardiac Magnetic Resonance in Detection of CHD
	Withdrawn	`NCT02122679` - Tranexamic Acid Effect on Platelet Aggregation Following Infant Cardiopulmonary Bypass	Phase 4

See also

Status

Clinical Trial

Phase

Recruiting

NCT05066399 - Fetal Cardiac Magnetic Resonance in Detection of CHD

Withdrawn

NCT02122679 - Tranexamic Acid Effect on Platelet Aggregation Following Infant Cardiopulmonary Bypass

Phase 4

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT03022708
Study type	Interventional
Source	Xeltis
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	May 8, 2017
Completion date	December 2026

Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study — Xplore2

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms