Pulmonary Valve MalfunctionPulmonicS3NCT02777892
Pulmonic SAPIEN S3™ THV Registry
An observational study of Pulmonary Valve Malfunction and Right Ventricular Outflow Tract (RVOT) Dysfunction, run by Institut für Pharmakologie und Präventive Medizin at 4 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 S3 transcatheter heart valve in the pulmonic position Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Valve Malfunction, Right Ventricular Outflow Tract (RVOT) Dysfunction
- What is being tested?
- Sapien S3
- How many people
- 50 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Mar 2016to 31 Jul 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, 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 3 THV made
- Data release form
Who cannot join
- none
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Germany2 sites
Deutsches Herzzentrum München
München, Bavaria, 80636
Herzchirurgische Klinik und Poliklinik LMU
München, Bavaria, 81377
About this study
Official title: Pulmonic SAPIEN S3™ THV Registry 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 S3 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.
- Being tested
- Sapien S3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sapien S3Other
Patients that have undergone percutaneous implantation of an Edwards SAPIEN S3 Transcatheter Heart Valve in the pulmonic position at the time of data collection
| Study group | Role | What they receive |
|---|---|---|
| pulmonary valve replacement | SAPIEN S3 Transcatheter Heart Valve in the pulmonic position at the time of data collection Receives: Other: Sapien S3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in right ventricular and pulmonary artery pressure
Measured: from baseline to 30 days after implantation
Secondary outcomes (7)
Max. flow velocity RVOT
Measured: 30 days after implantation
Changes in NYHA class
Measured: from baseline to 30 days after implantation
changes in degree of pulmonary regurgitation
Measured: from baseline to 30 days after implantation
length of hospitalization
Measured: 30 days after implantation
changes in Peak Oxygen consumption
Measured: from baseline to 24 months after implantation
Percentage of cases with proper device function
Measured: 24 months after implantation
Incidence of structural valve Deterioration including stent fracture
Measured: 24 months after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startMar 2016
- Primary completion31 Mar 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut für Pharmakologie und Präventive Medizin
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Peter Bramlage, Prof MD, Study director, Institut für Pharmakologie und Präventive Medizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777892
- Sponsor's protocol ID
- Pulmonic S3
- Acronym
- PulmonicS3
- Status last verified
- Sep 2023
- First submitted
- 12 May 2016
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonic SAPIEN S3™ THV Registry 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
- NCT02777892
- Acronym / sponsor ID
- PulmonicS3 / Pulmonic S3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institut für Pharmakologie und Präventive MedizinResearch network
- Study start
- Mar 2016 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 19 May 2016 (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 S3 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
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pulmonary valve replacement | – | Other: Sapien S3SAPIEN S3 Transcatheter Heart Valve in the pulmonic position at the time of data collection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 3 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 S3Patients that have undergone percutaneous implantation of an Edwards SAPIEN S3 Transcatheter Heart Valve in the pulmonic position at the time of data collection | Other | pulmonary valve replacement |
Primary outcome
changes in right ventricular and pulmonary artery pressure
Time frame: from baseline to 30 days after implantation
7 secondary outcomes
Max. flow velocity RVOT
Time frame: 30 days after implantation
Changes in NYHA class
Time frame: from baseline to 30 days after implantation
changes in degree of pulmonary regurgitation
Time frame: from baseline to 30 days after implantation
length of hospitalization
Time frame: 30 days after implantation
changes in Peak Oxygen consumption
Time frame: from baseline to 24 months after implantation
Percentage of cases with proper device function
Time frame: 24 months after implantation
Incidence of structural valve Deterioration including stent fracture
Time frame: 24 months after implantation
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 13 Sep 2023.
- on-line data entry siteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Peter Bramlage, Prof MD study director
Institut für Pharmakologie und Präventive Medizin
4 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 and Right Ventricular Outflow Tract (RVOT) Dysfunction, run by Institut für Pharmakologie und Präventive Medizin at 4 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 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Canada, 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?
changes in right ventricular and pulmonary artery pressure (time frame: from baseline to 30 days after implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2023.