A prospective, non-randomized, open label clinical study of a Restorative Pulmonary Heart Valve in Right Ventricular Outflow Tract (RVOT) reconstruction.
XPLORE-2 IS A CLINICAL RESEARCH STUDY ON AN INVESTIGATIONAL DEVICE NOT APPROVED FOR USE IN THE USA. THE STUDY IS ACTIVELY RECRUITING AND SEEKING ELIGIBLE CANDIDATES. PLEASE GET IN TOUCH TO FIND OUT MORE.
INCLUSION CRITERIA
The Xplore-2 study is actively recruiting patients in leading pediatric cardiac centers in the USA.
For further information on the involved centers please visit the Contacts Page.
Patients requiring RVOT reconstruction, suitable for 16 mm or 18 mm valved conduit, aged between 2 and 21 years, with any of the following congenital heart defects (CHD), and who fulfil all study criteria, may be eligible to participate:
- Tetralogy of Fallot
- Truncus Arteriosus
- Pulmonary Artresia
- Transposition of Great Arteries (TGA) with Ventricular Septal Defect (VSD)
- Pulmonary Stenosis with other CHD syndromes
- Replacement of previously implanted grafts (no mechanical valves)
- Ross procedure
A RESTORATIVE PULMONARY VALVE
The options currently available for RVOT reconstruction, from homografts to mechanical and animal-derived pulmonary valves, may either have limited durability leading to repeated interventions, or require life-long anticoagulation therapy, with potentially severe side effects.
To address these limitations, a new generation of restorative heart valves made of polymers have been developed by European company Xeltis.
They have a highly porous structure, designed to allow the patient’s own tissue to infiltrate it, to gradually restore a fully functional valve; this process is called Endogenous Tissue Restoration (ETR).
Such implants have a potential to reduce post-operative device-related complications and to adapt to the overall body growth.
They may therefore represent a completely new approach in heart valve therapy.
ENDOGENOUS TISSUE RESTORATION (ETR)
IMPLANTATION
NEOTISSUE FORMATION
FUNCTIONAL RESTORATION
STUDY OBJECTIVES
- Survival rate 6 and 12 months after implantation
- Valve failure rate at 6 months (re-intervention/re-operation)
- Survival rate at 60 months
- Valve failure rate at 12 months (re-intervention/re-operation)
- Pressure gradient at 6 months and 12 months
- Regurgitation at 6 months and 12 months
- Valve growth at 6, 36, 48 and 60 months (<18ys old only)
- Valve usability
- Survival rate at 60 months
- Device-related death rate at 6 months and 12 months
- Device-related re-operation/re-intervention at 6 months
- Survival rate at 60 months
- Device-related re-operation/re-intervention at 12 months
- Mean pressure gradient <40mmHg at 6 months and 12 months
- Pulmonary regurgitation ≤ moderate at 6 months and 12 months
- Valve growth at 6, 36, 48 and 60 months (<18ys old only)
- Device usability score
- Device related SAEs up to 60 months
TIMELINE
| Study Periods | Screening | Treatment | Follow Up | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Visit | 1: Baseline | 2: Intra-op | 3: Day 1 | 4: Day 7 Discharge | 5: 6 weeks | 6: Month 3 | 7: Month 6 | 8-14: 9, 12, 18, 24, 36, 48, 60 months | |
| Time (days) | > 30 days | Day 0 | 1 day | +/- 2 days | 6 weeks +/- 7 days | 3 months +/- 7 days | 6 months +/- 14 days | 9, 12, 18, 24, 36, 48, 60 months +/- 30 days | |
| Clinical examination | Patient information and consent | X | |||||||
| Medical history | X | ||||||||
| Demographics | X | ||||||||
| In-/Exclusion criteria | X | X | |||||||
| Height & Weight | X | X | X | X | X | X | |||
| Physical examination | X | X | X | X | X | X | X | ||
| Vital Signs | X | X | X | X | X | X | X | ||
| Medication | X | X | X | X | X | X | X | X | |
| NYHA score | X | X | X | ||||||
| Diagnostic tests | Laboratory tests | X | X | X | X | X | X | X | |
| Pregnancy test | X | X | X (up to 24 months) | ||||||
| ECG | X | X | X | X | X | X | |||
| Echocardiography (TTE) | X | X | X | X | X | X | |||
| Post-op variables | Implantation of device | X | |||||||
| Adverse effects | X | X | X | X | X | X | X | ||
To download a PDF of the timelines for this study please click the button below.
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,
phone: +866 818 8461 or email: xplore2@xeltis.com
FURTHER RESOURCES
For more information to share with your patients please visit xplore2trial.com or to explain more about RVOT reconstruction, watch Mended Little Hearts’ webinar ‘A Future without Reoperations’ by Professor Bennink, University of Cologne (D):
Download the Mended Little Hearts webinar ‘A Future without Reoperations’ in PDF format here:
This study is actively recruiting and seeking eligible candidates now at the following research centers:
Philadelphia
Children’s Hospital of Philadelphia Research Institute,
Philadelphia, Pennsylvania, 19104