Trial Outcomes & Findings for Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study (NCT NCT03022708)
NCT ID: NCT03022708
Last Updated: 2026-08-06
Results Overview
Measured once all 12 month follow up visits have been completed
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
12 months
Results posted on
2026-08-06
Participant Flow
Participant milestones
| Measure |
Xeltis Bioabsorbable Pulmonary Valved Conduit
The Bioabsorbable Pulmonary Valved Conduit bio-absorbable, polymer-based medical device.
The PV conduit is used in patients for correction or reconstruction of the Right Ventricular Outflow Tract (RVOT), in patients less than 22 years with any of the following congenital heart malformations:
* Tetralogy of Fallot
* Truncus Arteriosus
* Pulmonary Atresia
* Transposition of Great Arteries with Ventricular Septal Defect
* Pulmonary Stenosis in combination with other defects in congenital heart defect (CHD) syndromes
In addition, the PV conduit can be used for the following indications:
* replacement of previously implanted, but dysfunctional, pulmonary homografts or valved conduits (except for mechanical valves, see exclusion criterion 3).
* Patients undergoing a Ross procedure, where the PV conduit would replace the patient's own pulmonary valve which is used to replace a diseased aortic valve.
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|---|---|
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Overall Study
STARTED
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6
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Overall Study
12 month visit completed
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6
|
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Overall Study
Follow-up ongoing
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6
|
|
Overall Study
COMPLETED
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0
|
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Overall Study
NOT COMPLETED
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6
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study
Baseline characteristics by cohort
| Measure |
Xeltis Bioabsorbable Pulmonary Valved Conduit
n=6 Participants
The Bioabsorbable Pulmonary Valved Conduit bio-absorbable, polymer-based medical device.
The PV conduit is used in patients for correction or reconstruction of the Right Ventricular Outflow Tract (RVOT), in patients less than 22 years with any of the following congenital heart malformations:
* Tetralogy of Fallot
* Truncus Arteriosus
* Pulmonary Atresia
* Transposition of Great Arteries with Ventricular Septal Defect
* Pulmonary Stenosis in combination with other defects in congenital heart defect (CHD) syndromes
In addition, the PV conduit can be used for the following indications:
* replacement of previously implanted, but dysfunctional, pulmonary homografts or valved conduits (except for mechanical valves, see exclusion criterion 3).
* Patients undergoing a Ross procedure, where the PV conduit would replace the patient's own pulmonary valve which is used to replace a diseased aortic valve.
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|---|---|
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Age, Continuous
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6.5 Years
STANDARD_DEVIATION 3.0 • n=20 Participants
|
|
Sex: Female, Male
Female
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4 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Race · White
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5 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
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1 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 12 monthsMeasured once all 12 month follow up visits have been completed
Outcome measures
| Measure |
Xeltis Bioabsorbable Pulmonary Valved Conduit
n=6 Participants
The Bioabsorbable Pulmonary Valved Conduit bio-absorbable, polymer-based medical device.
The PV conduit is used in patients for correction or reconstruction of the Right Ventricular Outflow Tract (RVOT), in patients less than 22 years with any of the following congenital heart malformations:
* Tetralogy of Fallot
* Truncus Arteriosus
* Pulmonary Atresia
* Transposition of Great Arteries with Ventricular Septal Defect
* Pulmonary Stenosis in combination with other defects in congenital heart defect (CHD) syndromes
In addition, the PV conduit can be used for the following indications:
* replacement of previously implanted, but dysfunctional, pulmonary homografts or valved conduits (except for mechanical valves, see exclusion criterion 3).
* Patients undergoing a Ross procedure, where the PV conduit would replace the patient's own pulmonary valve which is used to replace a diseased aortic valve.
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|---|---|
|
Composite Rate of Events of Device Related Death, Re-operation or Re-intervention at 12 Months Follow-up.
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0 Participants
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SECONDARY outcome
Timeframe: 6 monthsMeasured once all 6 month follow up visits have been completed
Outcome measures
| Measure |
Xeltis Bioabsorbable Pulmonary Valved Conduit
n=6 Participants
The Bioabsorbable Pulmonary Valved Conduit bio-absorbable, polymer-based medical device.
The PV conduit is used in patients for correction or reconstruction of the Right Ventricular Outflow Tract (RVOT), in patients less than 22 years with any of the following congenital heart malformations:
* Tetralogy of Fallot
* Truncus Arteriosus
* Pulmonary Atresia
* Transposition of Great Arteries with Ventricular Septal Defect
* Pulmonary Stenosis in combination with other defects in congenital heart defect (CHD) syndromes
In addition, the PV conduit can be used for the following indications:
* replacement of previously implanted, but dysfunctional, pulmonary homografts or valved conduits (except for mechanical valves, see exclusion criterion 3).
* Patients undergoing a Ross procedure, where the PV conduit would replace the patient's own pulmonary valve which is used to replace a diseased aortic valve.
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|---|---|
|
Overall Rate of Device Related Death Due to Device Failure at 6 Months Follow up Post Implantation.
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0 Participants
|
SECONDARY outcome
Timeframe: 60 months post implantMeasured once all 60 month follow up visits have been completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsMeasured once all 12 month follow up visits have been completed.
Outcome measures
| Measure |
Xeltis Bioabsorbable Pulmonary Valved Conduit
n=6 Participants
The Bioabsorbable Pulmonary Valved Conduit bio-absorbable, polymer-based medical device.
The PV conduit is used in patients for correction or reconstruction of the Right Ventricular Outflow Tract (RVOT), in patients less than 22 years with any of the following congenital heart malformations:
* Tetralogy of Fallot
* Truncus Arteriosus
* Pulmonary Atresia
* Transposition of Great Arteries with Ventricular Septal Defect
* Pulmonary Stenosis in combination with other defects in congenital heart defect (CHD) syndromes
In addition, the PV conduit can be used for the following indications:
* replacement of previously implanted, but dysfunctional, pulmonary homografts or valved conduits (except for mechanical valves, see exclusion criterion 3).
* Patients undergoing a Ross procedure, where the PV conduit would replace the patient's own pulmonary valve which is used to replace a diseased aortic valve.
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|---|---|
|
Overall Rate of Subjects Who Require Reoperation or Re-intervention Due to Device Failure 12 Months.
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 and 12 monthsMeasured by echography at 6 and 12 months follow up.
Outcome measures
| Measure |
Xeltis Bioabsorbable Pulmonary Valved Conduit
n=6 Participants
The Bioabsorbable Pulmonary Valved Conduit bio-absorbable, polymer-based medical device.
The PV conduit is used in patients for correction or reconstruction of the Right Ventricular Outflow Tract (RVOT), in patients less than 22 years with any of the following congenital heart malformations:
* Tetralogy of Fallot
* Truncus Arteriosus
* Pulmonary Atresia
* Transposition of Great Arteries with Ventricular Septal Defect
* Pulmonary Stenosis in combination with other defects in congenital heart defect (CHD) syndromes
In addition, the PV conduit can be used for the following indications:
* replacement of previously implanted, but dysfunctional, pulmonary homografts or valved conduits (except for mechanical valves, see exclusion criterion 3).
* Patients undergoing a Ross procedure, where the PV conduit would replace the patient's own pulmonary valve which is used to replace a diseased aortic valve.
|
|---|---|
|
Overall Rate of Subjects With a Mean Pressure Gradient Across the Area of Conduit Implantation of Less Than 40 mm Hg at 6 and 12 Months Follow up.
at 6 months · Mean pressure gradient of less than 40 mm Hg
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5 Participants
|
|
Overall Rate of Subjects With a Mean Pressure Gradient Across the Area of Conduit Implantation of Less Than 40 mm Hg at 6 and 12 Months Follow up.
at 6 months · Mean pressure gradient of more than 40 mm Hg
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0 Participants
|
|
Overall Rate of Subjects With a Mean Pressure Gradient Across the Area of Conduit Implantation of Less Than 40 mm Hg at 6 and 12 Months Follow up.
at 6 months · Not assessable
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1 Participants
|
|
Overall Rate of Subjects With a Mean Pressure Gradient Across the Area of Conduit Implantation of Less Than 40 mm Hg at 6 and 12 Months Follow up.
at 12 months · Mean pressure gradient of less than 40 mm Hg
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5 Participants
|
|
Overall Rate of Subjects With a Mean Pressure Gradient Across the Area of Conduit Implantation of Less Than 40 mm Hg at 6 and 12 Months Follow up.
at 12 months · Mean pressure gradient of more than 40 mm Hg
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0 Participants
|
|
Overall Rate of Subjects With a Mean Pressure Gradient Across the Area of Conduit Implantation of Less Than 40 mm Hg at 6 and 12 Months Follow up.
at 12 months · Not assessable
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 and 12 monthsMeasured by echography at 6 and 12 months follow up.
Outcome measures
| Measure |
Xeltis Bioabsorbable Pulmonary Valved Conduit
n=6 Participants
The Bioabsorbable Pulmonary Valved Conduit bio-absorbable, polymer-based medical device.
The PV conduit is used in patients for correction or reconstruction of the Right Ventricular Outflow Tract (RVOT), in patients less than 22 years with any of the following congenital heart malformations:
* Tetralogy of Fallot
* Truncus Arteriosus
* Pulmonary Atresia
* Transposition of Great Arteries with Ventricular Septal Defect
* Pulmonary Stenosis in combination with other defects in congenital heart defect (CHD) syndromes
In addition, the PV conduit can be used for the following indications:
* replacement of previously implanted, but dysfunctional, pulmonary homografts or valved conduits (except for mechanical valves, see exclusion criterion 3).
* Patients undergoing a Ross procedure, where the PV conduit would replace the patient's own pulmonary valve which is used to replace a diseased aortic valve.
|
|---|---|
|
Overall Rate of Subjects With Pulmonary Regurgitation of Equal or Less Than Moderate at 6 and 12 Months Follow up.
at 6 months · Equal or less than moderate pulmonary regurgitation
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5 Participants
|
|
Overall Rate of Subjects With Pulmonary Regurgitation of Equal or Less Than Moderate at 6 and 12 Months Follow up.
at 6 months · More than moderate pulmonary regurgitation
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0 Participants
|
|
Overall Rate of Subjects With Pulmonary Regurgitation of Equal or Less Than Moderate at 6 and 12 Months Follow up.
at 6 months · Not assessable
|
1 Participants
|
|
Overall Rate of Subjects With Pulmonary Regurgitation of Equal or Less Than Moderate at 6 and 12 Months Follow up.
at 12 months · Equal or less than moderate pulmonary regurgitation
|
5 Participants
|
|
Overall Rate of Subjects With Pulmonary Regurgitation of Equal or Less Than Moderate at 6 and 12 Months Follow up.
at 12 months · More than moderate pulmonary regurgitation
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0 Participants
|
|
Overall Rate of Subjects With Pulmonary Regurgitation of Equal or Less Than Moderate at 6 and 12 Months Follow up.
at 12 months · Not assessable
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 60 monthsMeasured with echocardiography at 6, 36, 48 and 60 months follow up.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 - ImplantMeasured with a questionnaire given to the implanting surgeon at the time of implantation of the pulmonary valve conduit.
Outcome measures
Outcome data not reported
Adverse Events
Xeltis Bioabsorbable Pulmonary Valved Conduit
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Xeltis Bioabsorbable Pulmonary Valved Conduit
n=6 participants at risk
The Bioabsorbable Pulmonary Valved Conduit bio-absorbable, polymer-based medical device.
The PV conduit is used in patients for correction or reconstruction of the Right Ventricular Outflow Tract (RVOT), in patients less than 22 years with any of the following congenital heart malformations:
* Tetralogy of Fallot
* Truncus Arteriosus
* Pulmonary Atresia
* Transposition of Great Arteries with Ventricular Septal Defect
* Pulmonary Stenosis in combination with other defects in congenital heart defect (CHD) syndromes
In addition, the PV conduit can be used for the following indications:
* replacement of previously implanted, but dysfunctional, pulmonary homografts or valved conduits (except for mechanical valves, see exclusion criterion 3).
* Patients undergoing a Ross procedure, where the PV conduit would replace the patient's own pulmonary valve which is used to replace a diseased aortic valve.
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|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
16.7%
1/6 • From implant to 12 months follow-up
|
Other adverse events
| Measure |
Xeltis Bioabsorbable Pulmonary Valved Conduit
n=6 participants at risk
The Bioabsorbable Pulmonary Valved Conduit bio-absorbable, polymer-based medical device.
The PV conduit is used in patients for correction or reconstruction of the Right Ventricular Outflow Tract (RVOT), in patients less than 22 years with any of the following congenital heart malformations:
* Tetralogy of Fallot
* Truncus Arteriosus
* Pulmonary Atresia
* Transposition of Great Arteries with Ventricular Septal Defect
* Pulmonary Stenosis in combination with other defects in congenital heart defect (CHD) syndromes
In addition, the PV conduit can be used for the following indications:
* replacement of previously implanted, but dysfunctional, pulmonary homografts or valved conduits (except for mechanical valves, see exclusion criterion 3).
* Patients undergoing a Ross procedure, where the PV conduit would replace the patient's own pulmonary valve which is used to replace a diseased aortic valve.
|
|---|---|
|
Cardiac disorders
Junctional rhythm
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16.7%
1/6 • Number of events 1 • From implant to 12 months follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Rhinovirus
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16.7%
1/6 • Number of events 1 • From implant to 12 months follow-up
|
|
Infections and infestations
Enterovirus infection
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16.7%
1/6 • Number of events 1 • From implant to 12 months follow-up
|
|
Blood and lymphatic system disorders
Anemia
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16.7%
1/6 • Number of events 1 • From implant to 12 months follow-up
|
|
Blood and lymphatic system disorders
Possible localized thrombus
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16.7%
1/6 • Number of events 1 • From implant to 12 months follow-up
|
|
General disorders
Cough
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16.7%
1/6 • Number of events 1 • From implant to 12 months follow-up
|
|
Cardiac disorders
Mild PV Stenosis
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16.7%
1/6 • Number of events 1 • From implant to 12 months follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60