Infective EndocarditisEndopulmNCT06186258
Infective Endocarditis in Percutaneous Pulmonary Revalvulation: Comparison Between Melody and Sapien Valves
An observational study of Infective Endocarditis and Congenital Heart Disease, run by Centre Chirurgical Marie Lannelongue at 18 sites in 7 countries.
Trial summary
Percutaneous pulmonary valve revalvulation (PPVR) has emerged as an alternative to surgery for the treatment of congenital heart disease with right ejection pathway dysfunction. The Melody valve (Medtronic Inc., Minneapolis, Minnesota) was the first to be used, validated in 2006 by the European Commission and in 2010… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infective Endocarditis, Congenital Heart Disease, Percutaneous Pulmonary Valve Implantation
- What is being tested?
- percutaneous pulmonary valve implantation (PPVI)
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 18 sitesin 7 countries
- Study dates
- 17 Dec 2021to 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: The cohort will be made up of patients who have undergone successful percutaneous pulmonary revalvulation with the Melody valve, matched with patients who have undergone revalvulation with the Sapien valve (Sapien 3 and XT) between the years 2007 and 2021.
Who may be able to join
- Minor or adult patients who have undergone a successful percutaneous pulmonary revalvulation procedure
- Patients or legal guardians who do not object to the use of their data for this research.
Who cannot join
- Patients under guardianship or curatorship
- Patient deprived of liberty
- Patient under court protection
- Patient or legal guardian objecting to the use of his or her data for this research
Trial locations and contacts
18 sites in 7 countries.
18 sites in 7 countries
France8 sites
CHU Bordeaux
Bordeaux, 33000
CHU de Grenoble
Grenoble, 38500
Hopital Marie Lannelongue
Le Plessis-Robinson, 92350
CHRU Lille
Lille, 59000
CHU de la Timone
Marseille
CHU de Nantes
Nantes, 44000
Clinique Pasteur
Toulouse, 31000
CHU Toulouse
Toulouse, 31300
Spain3 sites
Vall d'Hebron University Hospital
Barcelona
12 de Octubre University Hospital,
Madrid
H. Ramón y Cajal University Hospital
Madrid
United Kingdom3 sites
Cardiology university Hospitals Birmingham
Birmingham
Bristol Heart Institute, University Hospitals Bristol & Weston NHS Foundation Trust
Bristol
Royal Brompton Hospital
London
Portugal1 site
Hospital de Santa Marta, Centro Hospitalar Lisboa Central-EPE
Lisbon
About this study
Official title: Infective Endocarditis in Percutaneous Pulmonary Revalvulation: a Direct Comparison Between Melody and Sapien Valves
Percutaneous pulmonary valve revalvulation (PPVR) has emerged as an alternative to surgery for the treatment of congenital heart disease with right ejection pathway dysfunction. The Melody valve (Medtronic Inc., Minneapolis, Minnesota) was the first to be used, validated in 2006 by the European Commission and in 2010 by the Food and Drug Administration (FDA). Subsequently, the Sapien valve (Edwards SAPIEN pulmonic transcatheter heart valve, Edwards Lifesciences, Irvine, California) was subsequently approved for PPVR (Europe, 2010; FDA 2016).
Infective endocarditis (IE) after PPVR is currently a major concern with an incidence after Melody PPVR estimated at 3%, much higher than the rate of prosthetic left-heart IE. The Sapien valve has been introduced more recently and some cases of IE have been published. Despite the attention this issue is receiving, there are few studies of sufficient size or statistical power to elucidate the risk factors for developing an IE after PPVR according to the type of valve implanted. Recently, a multicenter study was published by the American team of McElhinney et al (J Am Coll Cardiol 2021 ; 78 :575-589). Although it was a sizeable cohort (2476 patients), there was a large disparity in the ratio of patients who underwent revalvulation with either the Melody or Sapien valve, in favor of Melody patients (2038 Melody patients vs. 438 Sapien patients). In this study, the estimated risk of IE was higher for patients who received a Melody valve, according to univariable analysis but not anymore after multivariate analysis. To further answer this question, we develop an international retrospective multicenter registry whose main objective will be to characterize the incidence rate of infective endocarditis after percutaneous pulmonary revalvulation according to the type of valve implanted (Melody vs. Sapien) using a large population of patients with comparable characteristics (match-population).
Read the detailed description
Infective endocarditis (IE) is a dreaded complication in patients with congenital heart disease (CHD), with an incidence up to 100-fold compared to the general population. In CHD such as cono-truncal defects, the right ventricular outflow tract (RVOT) is reconstructed using patches, conduits, homografts or bioprosthetic valves. Subsequently, pulmonary regurgitation, conduit degeneration, or conduit mismatch due to growth may require repeated valve and/or conduit replacement. Transcatheter pulmonary valve implantation (TPVI) is an effective treatment for RVOT dysfunction, as an alternative to surgical pulmonary valve replacement. TPVI was first described in 2000 and, since then, many studies have supported its safety and efficacy. The MELODY valve (Medtronic Inc., Minneapolis, MN) was used first and received European certification in 2006 and FDA approval in 2010. The SAPIEN valve series (Edwards SAPIEN pulmonic transcatheter heart valve, and SAPIEN 3 valve, Edwards Lifesciences, Irvine, CA) were subsequently licensed for TPVI (Europe 2010; and FDA, 2016). The feasibility of TPVI was initially demonstrated in right ventricle-to-pulmonary artery conduits and then in bioprostheses, small expandable conduits, and native or patched RVOTs. IE after TPVI (TPVI-IE) remains a life-threatening adverse event that affects valve durability and patient outcomes. National and international recommendations provide only meager guidance about the management of TPVI-IE. A history of IE, Di George syndrome, male sex, younger age at implant and increased valve gradient have been identified as risk factors for IE. However it remains a matter of debate whether the type of valve influences the risk of IE. Although the bovine jugular vein valves like the MELODY valve and the CONTEGRA conduit are mentioned as specific risk factors for IE in the German guidelines for IE, other authors did not support this in a large multicentre study. An important limitation is that most of studies had limited duration of follow-up, particularly after SAPIEN-TPVI, whereas endocarditis has been equally described many years following TPVI. The objective of this study was to identify additional risk factors for TPVI-IE over the long-term.
METHODS A retrospective study of the multicentre international ENDOCPULM registry including consecutive patients after successful MELODY and SAPIEN-TPVI between 2007 and 2021 in 35 tertiary European and Middle-East centres was designed. The study was approved by an independent ethics committee (GERM IRB 00012157, #552, December 17th, 2021) and was performed in accordance with the Declaration of Helsinki and its amendments. This report complies with STROBE guidelines for cohort studies.
- Conditions
- Infective Endocarditis, Congenital Heart Disease, Percutaneous Pulmonary Valve Implantation
- Being tested
- percutaneous pulmonary valve implantation (PPVI)
- Keywords
- percutaneous pulmonary valve implantation, Sapien 3, Melody, Transcatheter pulmonary valve replacement, infective endocarditis, congenital heart disease
- Medical subject headings
- Endocarditis, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous pulmonary valve implantation (PPVI)Device
The only inclusion criterion is a successful PPVI to treat RVOT dysfunction. Procedural techniques were at each operator's discretion as well as post-procedure treatments and patient's follow-up. As we sought to assess IE incidence during follow-up, patients who underwent catheterization for intended PPVI but who did not had a successful valve implantation were not included. Successful PPVI was defined as patient discharged alive without valve surgery after successful valve implantation in the RVOT.
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent successful percutaneous pulmonary revalvulation with the Melody valve | Data from patients managed for a pulmonary revalvulation procedure with the Melody valve between 01/01/2007 and 31/12/2021 will be collected.
Cases of infective endocarditis will be meticulously examined and classified as certain, possible or refuted, according to the modified Duke algorithm proposed by the European Society of Cardiology.
Cases of endocarditis occurring within one year of pulmonary revalvulation will be classified as early IE and other cases as late IE Receives: Device: percutaneous pulmonary valve implantation (PPVI) | |
| Patients who underwent successful percutaneous pulmonary revalvulation with the Sapien 3, XT valve | Data from patients managed for a pulmonary revalvulation procedure with the Sapien 3, XT valve between 01/01/2007 and 31/12/2021 will be collected.
Cases of infective endocarditis will be meticulously examined and classified as certain, possible or refuted, according to the modified Duke algorithm proposed by the European Society of Cardiology.
Cases of endocarditis occurring within one year of pulmonary revalvulation will be classified as early IE and other cases as late IE Receives: Device: percutaneous pulmonary valve implantation (PPVI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the risk of long-term infective endocarditis after percutaneous pulmonary revalvulation with Melody, Sapien XT, Sapien S3 valves.
risk of long-term infective endocarditis after percutaneous pulmonary as defined by annualized incidence of infective endocarditis
Measured: 10 years
Secondary outcomes (1)
Major cardiovascular events
MAE are defined as during follow-up: need for further surgical or percutaneous pulmonary revalvulation, transplantation, thrombosis of implanted pulmonary valve and death
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start17 Dec 2021
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Infective EndocarditisStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Chirurgical Marie Lannelongue
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain Fraisse, MD, PhD, Study director, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186258
- Sponsor's protocol ID
- 2022-552
- Acronym
- Endopulm
- Status last verified
- Dec 2023
- First submitted
- 15 Dec 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Godart F, Baruteau AE, Petit J, Riou JY, Sassolas F, Lusson JR, Fraisse A, Boudjemline Y. Transcatheter tricuspid valve implantation: a multicentre French study. Arch Cardiovasc Dis. 2014 Nov;107(11):583-91. doi: 10.1016/j.acvd.2014.07.051. Epub 2014 Oct 2.
PubMed 25282331Hascoet S, Acar P, Boudjemline Y. Transcatheter pulmonary valvulation: current indications and available devices. Arch Cardiovasc Dis. 2014 Nov;107(11):625-34. doi: 10.1016/j.acvd.2014.07.048. Epub 2014 Oct 31.
PubMed 25444020Malekzadeh-Milani S, Houeijeh A, Jalal Z, Hascoet S, Bakloul M, Aldebert P, Piechaud JF, Heitz F, Bouvaist H, Dauphin C, Guerin P, Villemain O, Petit J, Godart F, Thambo JB, Boudjemline Y; French working group of Cardiac Catheterization in Congenital Heart Disease Patients. French national survey on infective endocarditis and the Melody valve in percutaneous pulmonary valve implantation. Arch Cardiovasc Dis. 2018 Aug-Sep;111(8-9):497-506. doi: 10.1016/j.acvd.2017.10.007. Epub 2018 Mar 9.
PubMed 29530718Hascoet S, Karsenty C, Tortigue M, Watkins AC, Riou JY, Boet A, Tahhan N, Fabre D, Haulon S, Brenot P, Petit J. A modified procedure for percutaneous pulmonary valve implantation of the Edwards SAPIEN 3 valve. EuroIntervention. 2019 Jan 20;14(13):1386-1388. doi: 10.4244/EIJ-D-18-00530. No abstract available.
PubMed 30327285Shahanavaz S, Zahn EM, Levi DS, Aboulhousn JA, Hascoet S, Qureshi AM, Porras D, Morgan GJ, Bauser Heaton H, Martin MH, Keeshan B, Asnes JD, Kenny D, Ringewald JM, Zablah JE, Ivy M, Morray BH, Torres AJ, Berman DP, Gillespie MJ, Chaszczewski K, Zampi JD, Walsh KP, Julien P, Goldstein BH, Sathanandam SK, Karsenty C, Balzer DT, McElhinney DB. Transcatheter Pulmonary Valve Replacement With the Sapien Prosthesis. J Am Coll Cardiol. 2020 Dec 15;76(24):2847-2858. doi: 10.1016/j.jacc.2020.10.041.
PubMed 33303074Le Ruz R, Plessis J, Houeijeh A, Baruteau AE, Le Gloan L, Warin Fresse K, Karsenty C, Petit J, Godart F, Hascoet S, Guerin P. Edwards SAPIEN XT transcatheter pulmonary valve implantation: 5-year follow-up in a French Registry. Catheter Cardiovasc Interv. 2021 Nov 1;98(5):990-999. doi: 10.1002/ccd.29862. Epub 2021 Jul 6.
PubMed 34227735
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infective Endocarditis in Percutaneous Pulmonary Revalvulation: a Direct Comparison Between Melody and Sapien Valves
- ClinicalTrials.gov ID
- NCT06186258
- Acronym / sponsor ID
- Endopulm / 2022-552
- Conditions
- Infective Endocarditis, Congenital Heart Disease, Percutaneous Pulmonary Valve Implantation
- Keywords
- percutaneous pulmonary valve implantation, Sapien 3, Melody, Transcatheter pulmonary valve replacement, infective endocarditis, congenital heart disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Centre Chirurgical Marie LannelongueUniversity, hospital or other
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 29 Dec 2023 (actual)
- 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.
Percutaneous pulmonary valve revalvulation (PPVR) has emerged as an alternative to surgery for the treatment of congenital heart disease with right ejection pathway dysfunction. The Melody valve (Medtronic Inc., Minneapolis, Minnesota) was the first to be used, validated in 2006 by the European Commission and in 2010 by the Food and Drug Administration (FDA). Subsequently, the Sapien valve (Edwards SAPIEN pulmonic transcatheter heart valve, Edwards Lifesciences, Irvine, California) was subsequently approved for PPVR (Europe, 2010; FDA 2016).
Infective endocarditis (IE) after PPVR is currently a major concern with an incidence after Melody PPVR estimated at 3%, much higher than the rate of prosthetic left-heart IE. The Sapien valve has been introduced more recently and some cases of IE have been published. Despite the attention this issue is receiving, there are few studies of sufficient size or statistical power to elucidate the risk factors for developing an IE after PPVR according to the type of valve implanted. Recently, a multicenter study was published by the American team of McElhinney et al (J Am Coll Cardiol 2021 ; 78 :575-589). Although it was a sizeable cohort (2476 patients), there was a large disparity in the ratio of patients who underwent revalvulation with either the Melody or Sapien valve, in favor of Melody patients (2038 Melody patients vs. 438 Sapien patients). In this study, the estimated risk of IE was higher for patients who received a Melody valve, according to univariable analysis but not anymore after multivariate analysis. To further answer this question, we develop an international retrospective multicenter registry whose main objective will be to characterize the incidence rate of infective endocarditis after percutaneous pulmonary revalvulation according to the type of valve implanted (Melody vs. Sapien) using a large population of patients with comparable characteristics (match-population).
Detailed description
Infective endocarditis (IE) is a dreaded complication in patients with congenital heart disease (CHD), with an incidence up to 100-fold compared to the general population. In CHD such as cono-truncal defects, the right ventricular outflow tract (RVOT) is reconstructed using patches, conduits, homografts or bioprosthetic valves. Subsequently, pulmonary regurgitation, conduit degeneration, or conduit mismatch due to growth may require repeated valve and/or conduit replacement. Transcatheter pulmonary valve implantation (TPVI) is an effective treatment for RVOT dysfunction, as an alternative to surgical pulmonary valve replacement. TPVI was first described in 2000 and, since then, many studies have supported its safety and efficacy. The MELODY valve (Medtronic Inc., Minneapolis, MN) was used first and received European certification in 2006 and FDA approval in 2010. The SAPIEN valve series (Edwards SAPIEN pulmonic transcatheter heart valve, and SAPIEN 3 valve, Edwards Lifesciences, Irvine, CA) were subsequently licensed for TPVI (Europe 2010; and FDA, 2016). The feasibility of TPVI was initially demonstrated in right ventricle-to-pulmonary artery conduits and then in bioprostheses, small expandable conduits, and native or patched RVOTs. IE after TPVI (TPVI-IE) remains a life-threatening adverse event that affects valve durability and patient outcomes. National and international recommendations provide only meager guidance about the management of TPVI-IE. A history of IE, Di George syndrome, male sex, younger age at implant and increased valve gradient have been identified as risk factors for IE. However it remains a matter of debate whether the type of valve influences the risk of IE. Although the bovine jugular vein valves like the MELODY valve and the CONTEGRA conduit are mentioned as specific risk factors for IE in the German guidelines for IE, other authors did not support this in a large multicentre study. An important limitation is that most of studies had limited duration of follow-up, particularly after SAPIEN-TPVI, whereas endocarditis has been equally described many years following TPVI. The objective of this study was to identify additional risk factors for TPVI-IE over the long-term.
METHODS A retrospective study of the multicentre international ENDOCPULM registry including consecutive patients after successful MELODY and SAPIEN-TPVI between 2007 and 2021 in 35 tertiary European and Middle-East centres was designed. The study was approved by an independent ethics committee (GERM IRB 00012157, #552, December 17th, 2021) and was performed in accordance with the Declaration of Helsinki and its amendments. This report complies with STROBE guidelines for cohort studies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent successful percutaneous pulmonary revalvulation with the Melody valve | – | Device: percutaneous pulmonary valve implantation (PPVI)Data from patients managed for a pulmonary revalvulation procedure with the Melody valve between 01/01/2007 and 31/12/2021 will be collected. Cases of infective endocarditis will be meticulously examined and classified as certain, possible or refuted, according to the modified Duke algorithm proposed by the European Society of Cardiology. Cases of endocarditis occurring within one year of pulmonary revalvulation will be classified as early IE and other cases as late IE |
| Patients who underwent successful percutaneous pulmonary revalvulation with the Sapien 3, XT valve | – | Device: percutaneous pulmonary valve implantation (PPVI)Data from patients managed for a pulmonary revalvulation procedure with the Sapien 3, XT valve between 01/01/2007 and 31/12/2021 will be collected. Cases of infective endocarditis will be meticulously examined and classified as certain, possible or refuted, according to the modified Duke algorithm proposed by the European Society of Cardiology. Cases of endocarditis occurring within one year of pulmonary revalvulation will be classified as early IE and other cases as late IE |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The cohort will be made up of patients who have undergone successful percutaneous pulmonary revalvulation with the Melody valve, matched with patients who have undergone revalvulation with the Sapien valve (Sapien 3 and XT) between the years 2007 and 2021.
Key inclusion criteria (2 listed)
- Minor or adult patients who have undergone a successful percutaneous pulmonary revalvulation procedure
- Patients or legal guardians who do not object to the use of their data for this research.
Key exclusion criteria (4 listed)
- Patients under guardianship or curatorship
- Patient deprived of liberty
- Patient under court protection
- Patient or legal guardian objecting to the use of his or her data for this research
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 |
|---|---|---|
| percutaneous pulmonary valve implantation (PPVI)The only inclusion criterion is a successful PPVI to treat RVOT dysfunction. Procedural techniques were at each operator's discretion as well as post-procedure treatments and patient's follow-up. As we sought to assess IE incidence during follow-up, patients who underwent catheterization for intended PPVI but who did not had a successful valve implantation were not included. Successful PPVI was defined as patient discharged alive without valve surgery after successful valve implantation in the RVOT. | Device | Patients who underwent successful percutaneous pulmonary revalvulation with the Melody valve, Patients who underwent successful percutaneous pulmonary revalvulation with the Sapien 3, XT valve |
Primary outcome
compare the risk of long-term infective endocarditis after percutaneous pulmonary revalvulation with Melody, Sapien XT, Sapien S3 valves.
Time frame: 10 years
risk of long-term infective endocarditis after percutaneous pulmonary as defined by annualized incidence of infective endocarditis
1 secondary outcome
Major cardiovascular events
Time frame: 10 years
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 29 Dec 2023.
- Background: PubMed 25282331Godart F, Baruteau AE, Petit J, Riou JY, Sassolas F, Lusson JR, Fraisse A, Boudjemline Y. Transcatheter tricuspid valve implantation: a multicentre French study. Arch Cardiovasc Dis. 2014 Nov;107(11):583-91. doi: 10.1016/j.acvd.2014.07.051. Epub 2014 Oct 2.
- Background: PubMed 25444020Hascoet S, Acar P, Boudjemline Y. Transcatheter pulmonary valvulation: current indications and available devices. Arch Cardiovasc Dis. 2014 Nov;107(11):625-34. doi: 10.1016/j.acvd.2014.07.048. Epub 2014 Oct 31.
- Background: PubMed 29530718Malekzadeh-Milani S, Houeijeh A, Jalal Z, Hascoet S, Bakloul M, Aldebert P, Piechaud JF, Heitz F, Bouvaist H, Dauphin C, Guerin P, Villemain O, Petit J, Godart F, Thambo JB, Boudjemline Y; French working group of Cardiac Catheterization in Congenital Heart Disease Patients. French national survey on infective endocarditis and the Melody valve in percutaneous pulmonary valve implantation. Arch Cardiovasc Dis. 2018 Aug-Sep;111(8-9):497-506. doi: 10.1016/j.acvd.2017.10.007. Epub 2018 Mar 9.
- Background: PubMed 30327285Hascoet S, Karsenty C, Tortigue M, Watkins AC, Riou JY, Boet A, Tahhan N, Fabre D, Haulon S, Brenot P, Petit J. A modified procedure for percutaneous pulmonary valve implantation of the Edwards SAPIEN 3 valve. EuroIntervention. 2019 Jan 20;14(13):1386-1388. doi: 10.4244/EIJ-D-18-00530. No abstract available.
- Background: PubMed 33303074Shahanavaz S, Zahn EM, Levi DS, Aboulhousn JA, Hascoet S, Qureshi AM, Porras D, Morgan GJ, Bauser Heaton H, Martin MH, Keeshan B, Asnes JD, Kenny D, Ringewald JM, Zablah JE, Ivy M, Morray BH, Torres AJ, Berman DP, Gillespie MJ, Chaszczewski K, Zampi JD, Walsh KP, Julien P, Goldstein BH, Sathanandam SK, Karsenty C, Balzer DT, McElhinney DB. Transcatheter Pulmonary Valve Replacement With the Sapien Prosthesis. J Am Coll Cardiol. 2020 Dec 15;76(24):2847-2858. doi: 10.1016/j.jacc.2020.10.041.
- Background: PubMed 34227735Le Ruz R, Plessis J, Houeijeh A, Baruteau AE, Le Gloan L, Warin Fresse K, Karsenty C, Petit J, Godart F, Hascoet S, Guerin P. Edwards SAPIEN XT transcatheter pulmonary valve implantation: 5-year follow-up in a French Registry. Catheter Cardiovasc Interv. 2021 Nov 1;98(5):990-999. doi: 10.1002/ccd.29862. Epub 2021 Jul 6.
- Individual participant dataSharing planned: No
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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.
Alain Fraisse, MD, PhD study director
Royal Brompton & Harefield NHS Foundation Trust
18 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infective Endocarditis and Congenital Heart Disease, run by Centre Chirurgical Marie Lannelongue at 18 sites in 7 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 4 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 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France, Spain, United Kingdom, Germany, Italy and 2 more countries. 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?
compare the risk of long-term infective endocarditis after percutaneous pulmonary revalvulation with Melody, Sapien XT, Sapien S3 valves. (time frame: 10 years). 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 NCT06186258, which also lists 6 linked publications.
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 29 Dec 2023.