XPLORE2/PIVOTAL STUDY OVERVIEW

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Patients
50Patients

Patients aged 2-21 years old requiring RVOT reconstruction *

*Inclusion and exclusion criteria apply
Up to15sites in USA, Europe, Asia

Principal Investigator: Dr David Morales – Cincinnati Children’s Hospital Medical Center

PRIMARY ENDPOINTS

Composite rate of device related events (deaths, re-operations or re-interventions) at 12-month follow-up

SECONDARY ENDPOINTS

Overall rate of subjects who require re-operation or re-intervention due to device failure at 6 months

Overall rate of subjects with pulmonary regurgitation of equal or less than moderate at 6- and 12-month follow-up

Overall rate of mortality at 60-month follow-up post implantation

Overall rate of subjects with a mean pressure gradient across the area of conduit implantation (RV to PA) of less than 40 mmHg at 6- and 12-month follow-up

Overall rate of device-related deaths due to device failure at 6-month follow-up post implantation

INCLUSION CRITERIA

Patients requiring correction or reconstruction of the Right Ventricular Outflow Tract (RVOT) due to congenital heart malformations. This includes patients in need of replacement of a previously implanted, but dysfunctional, homograft / pulmonary valved conduit, as well as patients undergoing a Ross procedure.

Patient suitable for 16 mm, 18 mm, 20mm, and 22mm valved conduit
Age > 2 years and < 22 years
Right Ventricular to Pulmonary Artery peak gradient > 35mm Hg or moderate or severe Pulmonary regurgitation (≥3+), or have both (except for the patients undergoing a Ross procedure)

EXCLUSION CRITERIA*

Need for or presence of prosthetic heart valve at other position
Need for concomitant surgical procedures (non-cardiac)
Patients with previously implanted pacemaker (including defibrillators), or mechanical valves
Active endocarditis or infection requiring current antibiotic therapy (if temporary illness, the patient may be a candidate four weeks after discontinuation of antibiotics) or viral infection
Leukopenia, Anemia, Thrombocytopenia
Pulmonary hypertension (≥ half of systemic systolic pressure)

*Disclaimer: This is only a selection of key criteria. Please consult the participating research centers or clinicaltrials.gov for more information.

For full study information and details please visit:
http://www.clinicaltrials.gov Study Number NCT03022708.
To learn more about Xeltis, the study sponsor, please visit www.xeltis.com