Pulmonary Valve MalfunctionPulmonic XTNCT02302131
Pulmonic SAPIEN XT THV
An observational study of Pulmonary Valve Malfunction, run by Institut für Pharmakologie und Präventive Medizin at 6 sites in 3 countries.
Trial summary
Multi-center, Observational Registry with Retrospective Enrollment and Prospective Follow-up. The aim of the registry is to document the feasibility and safety of implanting an Edwards SAPIEN XT transcatheter heart valve in the pulmonic position. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Valve Malfunction
- What is being tested?
- SAPIEN XT
- How many people
- 49 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Nov 2014to Apr 2017
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that have undergone percutaneous implantation of an Edwards SAPIEN XT Transcatheter Heart Valve in the pulmonic position at the time of data collection
Who may be able to join
- Clinical indication and decision for the implantation of an Edwards SAPIEN XT THV made
- Data release form
Who cannot join
- none
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Canada3 sites
Hospital Laval, Ste Foy
Montreal, Quebec, G1V 4G5
Toronto General
Toronto, Ontario, M5G 2C4
St Pauls Hospital
Vancouver, British Columbia, V6Z 1Y6
Switzerland1 site
Universitätshospital Zürich
Zurich, Canton of Zurich, 8091
About this study
Official title: Pulmonic SAPIEN XT™ THV A Multi-center, Observational Registry With Retrospective Enrollment of Patients That Underwent Transcatheter Pulmonic Valve Implantation and a Retrospective or Prospective Follow-up
Multi-center, Observational Registry with Retrospective Enrollment and Prospective Follow-up.
The aim of the registry is to document the feasibility and safety of implanting an Edwards SAPIEN XT transcatheter heart valve in the pulmonic position.
Read the detailed description
A malfunction or dysplasia of the pulmonary valve or the right ventricular outflow tract (RVOT) is one of the major components of the cardiac physiology in many congenital heart defects. Surgical correction of complex heart defects often includes some form of surgical repair or replacement of the native RVOT by biological valves such as homograft, bioprosthesis or Xenografts (i.e., Contegra conduits). Typical examples are tetralogy of Fallot (TOF) or double outlet right ventricle (DORV), pulmonary stenosis (PS), pulmonary atresia (PA), truncus arteriosus (TA), transposition of the great arteries (TGA) with PS (Rastelli's operation), absent pulmonary valve syndrome (Miller-Lev-Paul), Ross surgery for aortic valve disease and others. The repaired or replaced pulmonary valve however often becomes dysfunctional later on and many patients require surgical revisions of the RVOT with pulmonary valve replacement within 10 years of primary intervention.
TPVI provides a less invasive alternative to surgery in patients with right ventricular-to-pulmonary artery (RV-PA) conduit dysfunction. Early results of percutaneous pulmonary valve implantation (PPVI) showed that it is a promising procedure compared to a conventional surgical intervention. Meanwhile, pre-stenting of the RVOT before PPVI is routinely performed, enabling PPVI in various anatomies.
- Conditions
- Pulmonary Valve Malfunction
- Being tested
- SAPIEN XT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAPIEN XTOther
Patients that have undergone percutaneous implantation of an Edwards SAPIEN XT Transcatheter Heart Valve in the pulmonic position at the time of data collection
| Study group | Role | What they receive |
|---|---|---|
| pulmonary valve replacement | SAPIEN XT Transcatheter Heart Valve in the pulmonic position at the time of data collection Receives: Other: SAPIEN XT |
What is being measured
The primary outcome is the main question the study is designed to answer.
right ventricular and pulmonary artery pressure
Measured: 30 days
max flow velocity RVOT
Measured: 30 days
NYHA class
Measured: 30 days
degree of pulmonary regurgitation
Measured: 30 days
procedural success
Measured: 30 days
Peak gradient
Measured: 30 days
length of hospitalization
Measured: 30 days
Peak Oxygen consumption
Measured: 24 months
anaerobic threshold
Measured: 24 months
device function
Measured: 24 months
structural valve Deterioration including stent fracture
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2015
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Valve MalfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 49 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Institut für Pharmakologie und Präventive Medizin
- Sponsor type
- Research network
- Collaborators
- Estimate, GmbH
- Responsible party
- Sponsor
- Investigators
- Nikolaus Haas, MD, Principal investigator, Center for Congenital Heart Defects, Heart and Diabetes Center NRWPeter Bramlage, MD, Principal investigator, IPPMed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302131
- Sponsor's protocol ID
- EU Pulmonic XT
- Acronym
- Pulmonic XT
- Status last verified
- Apr 2017
- First submitted
- 24 Nov 2014
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Haas NA, Carere RG, Kretschmar O, Horlick E, Rodes-Cabau J, de Wolf D, Gewillig M, Mullen M, Lehner A, Deutsch C, Bramlage P, Ewert P. Early outcomes of percutaneous pulmonary valve implantation using the Edwards SAPIEN XT transcatheter heart valve system. Int J Cardiol. 2018 Jan 1;250:86-91. doi: 10.1016/j.ijcard.2017.10.015. Epub 2017 Oct 6.
PubMed 29017776
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonic SAPIEN XT™ THV A Multi-center, Observational Registry With Retrospective Enrollment of Patients That Underwent Transcatheter Pulmonic Valve Implantation and a Retrospective or Prospective Follow-up
- ClinicalTrials.gov ID
- NCT02302131
- Acronym / sponsor ID
- Pulmonic XT / EU Pulmonic XT
- Conditions
- Pulmonary Valve Malfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Institut für Pharmakologie und Präventive MedizinResearch network
- Collaborators
- Estimate, GmbH
- Study start
- Nov 2014 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 26 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multi-center, Observational Registry with Retrospective Enrollment and Prospective Follow-up.
The aim of the registry is to document the feasibility and safety of implanting an Edwards SAPIEN XT transcatheter heart valve in the pulmonic position.
Detailed description
A malfunction or dysplasia of the pulmonary valve or the right ventricular outflow tract (RVOT) is one of the major components of the cardiac physiology in many congenital heart defects. Surgical correction of complex heart defects often includes some form of surgical repair or replacement of the native RVOT by biological valves such as homograft, bioprosthesis or Xenografts (i.e., Contegra conduits). Typical examples are tetralogy of Fallot (TOF) or double outlet right ventricle (DORV), pulmonary stenosis (PS), pulmonary atresia (PA), truncus arteriosus (TA), transposition of the great arteries (TGA) with PS (Rastelli's operation), absent pulmonary valve syndrome (Miller-Lev-Paul), Ross surgery for aortic valve disease and others. The repaired or replaced pulmonary valve however often becomes dysfunctional later on and many patients require surgical revisions of the RVOT with pulmonary valve replacement within 10 years of primary intervention.
TPVI provides a less invasive alternative to surgery in patients with right ventricular-to-pulmonary artery (RV-PA) conduit dysfunction. Early results of percutaneous pulmonary valve implantation (PPVI) showed that it is a promising procedure compared to a conventional surgical intervention. Meanwhile, pre-stenting of the RVOT before PPVI is routinely performed, enabling PPVI in various anatomies.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pulmonary valve replacement | – | Other: SAPIEN XTSAPIEN XT Transcatheter Heart Valve in the pulmonic position at the time of data collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that have undergone percutaneous implantation of an Edwards SAPIEN XT Transcatheter Heart Valve in the pulmonic position at the time of data collection
Key inclusion criteria (2 listed)
- Clinical indication and decision for the implantation of an Edwards SAPIEN XT THV made
- Data release form
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAPIEN XTPatients that have undergone percutaneous implantation of an Edwards SAPIEN XT Transcatheter Heart Valve in the pulmonic position at the time of data collection | Other | pulmonary valve replacement |
Primary outcome
right ventricular and pulmonary artery pressure
Time frame: 30 days
max flow velocity RVOT
Time frame: 30 days
NYHA class
Time frame: 30 days
degree of pulmonary regurgitation
Time frame: 30 days
procedural success
Time frame: 30 days
Peak gradient
Time frame: 30 days
length of hospitalization
Time frame: 30 days
Peak Oxygen consumption
Time frame: 24 months
anaerobic threshold
Time frame: 24 months
device function
Time frame: 24 months
structural valve Deterioration including stent fracture
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- Derived from this study: PubMed 29017776Haas NA, Carere RG, Kretschmar O, Horlick E, Rodes-Cabau J, de Wolf D, Gewillig M, Mullen M, Lehner A, Deutsch C, Bramlage P, Ewert P. Early outcomes of percutaneous pulmonary valve implantation using the Edwards SAPIEN XT transcatheter heart valve system. Int J Cardiol. 2018 Jan 1;250:86-91. doi: 10.1016/j.ijcard.2017.10.015. Epub 2017 Oct 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikolaus Haas, MD principal investigator
Center for Congenital Heart Defects, Heart and Diabetes Center NRW
Peter Bramlage, MD principal investigator
IPPMed
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Valve Malfunction, run by Institut für Pharmakologie und Präventive Medizin at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada, Belgium, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
right ventricular and pulmonary artery pressure (time frame: 30 days). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02302131, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2017.