Sinus Venosus DefectOPTIVENOSUSNCT05865119
OPTImal Treatment of Sinus VENOSUS Defect
A study testing OPTIMUS covered stent and Surgical correction of a SVD in people with Sinus Venosus Defect and Congenital Heart Disease, run by Centre Chirurgical Marie Lannelongue at 13 sites in France.
Trial summary
Sinus venosus defect (SVD) accounts for 10% of atrial septal defects and is characterized by an anomalous pulmonary venous return in the superior vena cava associated with a high situated atrial septal defect. Since 2013, transcatheter correction of this congenital heart disease has emerged as a new treatment option. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Sinus Venosus Defect, Congenital Heart Disease, Sinus Venosus Atrial Septum Defect
- What is being tested?
- OPTIMUS covered stent and Surgical correction of a SVD
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 13 sitesFrance
- Study dates
- 12 May 2023to 12 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- from 12 years of age
- SVD with right ventricular end-diastolic volume dilatation (RV EDV) on imaging (echocardiography and/or MRI), defined by the guidelines as RV EDV greater than 112mL/m2 for women and 121 mL/m2 for men.
- With an indication for atrial septal defect correction, indicated at a medical-surgical meeting according to the ESC 2020 guideline criteria
- Adult patients who received informed information about the study and signed a consent to participate in the study
- Minor patients, no opposition from both holders of parental authority to data processing.
- Patient agreeing to be followed for the duration of the study
- Affiliated or beneficiary of a social security plan NB: Minor patients will only be considered eligible for the surgical procedure and will be studied descriptively.
Who cannot join
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under judicial protection
- Pregnant or breastfeeding woman
- Patient already included in an interventional research protocol
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
France13 sites, 13 recruiting
- Not yet recruiting
CHU Bordeaux
Bordeaux, 33404
Jean-Benoit THAMBO, jean-benoit.thambo@chu-bordeaux.fr
Jean-Benoit THAMBO
- Not yet recruiting
Hospices Civils de Lyon
Bron, 69500
Mohamed BAKLOUL, mohamed.bakloul@chu-lyon.fr
Mohamed BAKLOUL
- Not yet recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63000
Claire DAUPHIN
Claire DAUPHIN
- Recruiting
CHU Grenoble
Grenoble, 38700
Hélène BOUVAIST, hbouvaist@chu-grenoble.fr
Helene BOUVAIST
- Recruiting
Sébastien HASCOËT
Le Plessis-Robinson, 92350
Sébastien HASCOËT, s.hascoet@ghpsj.fr
Clément BATTEUX
- Recruiting
CHU Lille
Lille, 59000
François GODART, francois.godart@chru-lille.fr
François GODART
- Not yet recruiting
Hôpitaux universitaire de Marseille
Marseille, 13385
Caroline OVAERT, caroline.ovaert@ap-hm.fr
Caroline OVAERT
- Not yet recruiting
CHU Nantes
Nantes, 44000
Alban-Elouen BARUTEAU, albanelouen.baruteau@chu-nantes.fr
Alban-Elouen BARUTEAU
- Not yet recruiting
CHU Necker APHP Paris
Paris, 75015
Sophie MALEKZADEH, Sophie.malekzadeh@aphp.fr
Sophie MALEKZADEH
- Not yet recruiting
HEGP Paris
Paris, 75015
Sophie MALEKZADEH, Sophie.malekzadeh@aphp.fr
Sophie MALEKZADEH
- Not yet recruiting
CHU Toulouse
Toulouse, 31300
Clément KARSENTY
Clément KARSENTY
- Not yet recruiting
Clinique Pasteur, Toulouse
Toulouse, 31300
Nicolas COMBES, n.combes@clinique-pasteur.com
Nicolas COMBES
- Not yet recruiting
CHU Tours
Tours, 37000
Bruno LEFORT, b.lefort@univ-tours.fr
Bruno LEFORT
About this study
Official title: OPTImal Treatment of Sinus VENOSUS Defect - Efficacy and Safety of Transcatheter Correction Compared to Surgical Treatment in Patients With Sinus Venosus Defect
Sinus venosus defect (SVD) accounts for 10% of atrial septal defects and is characterized by an anomalous pulmonary venous return in the superior vena cava associated with a high situated atrial septal defect. Since 2013, transcatheter correction of this congenital heart disease has emerged as a new treatment option. The procedure involves placement of a covered stent in the superior vena cava that tunnels the anomalous pulmonary venous return to the left atrium. Preliminary results are limited but promising.
The devices to be used depend on anatomic considerations. XXL stents than 70mm are often required. Today, the availability of CE marked stents is limited. There have been recent reports of successful corrections with the specifically developed Optimus XXL 100mm covered stent (ANDRATEC) with compassionate approval from the Agence Nationale de Sûreté du Médicament in France. Setting up a feasibility study to investigate the use of medical devices in this indication was required.
Read more
The objective of this project is to study the feasibility, efficacy and safety of the Optimus stent in this newly developed transcatheter procedure, in comparison with the gold-standard surgical method. A French national multicenter comparative cohort study including all eligible patients referred for transcatheter correction of SVD was designed. The feasibility of the transcatheter procedures will be investigated beforehand by virtual digital simulation and simulation on a 3D printed model. The procedures will then be performed in centers of the M3C network for complex congenital heart diseases (CARDIOGEN). The primary endpoint will be a composite of efficacy, defined as complete occlusion of the shunt, and safety, defined as the absence of major events at 6 months. The secondary endpoints will be anatomical, functional and psychosocial (quality of life).
It is expected that transcatheter treatment gives comparable results to surgery on the primary endpoint. This could justify the further development of this procedure as an alternative to surgery and facilitate the validation of dedicated equipment.
Read the detailed description
OPTIVENOSUS will be offered to patients who have an correction of SVD. A pre-therapeutic assessment will be prescribed with a CT scan and MRI, followed by a complementary assessment with a 6-minute walk test, a functional cardiorespiratory examination, a Holter and an ECG.
In addition, the images from the CT scan carried out during the pre-therapeutic assessment will be transferred to a secure platform approved for hosting health data. These images will be the subject of a 3D reconstruction.
Then a multidisciplinary consultation meeting held by paediatric cardiologists, specialists in adult congenital heart disease, surgeons and interventional cardiologists will be held to assess whether or not the patient is ineligible for surgery and whether or not the patient is eligible for transcatheter correction of SVD on the basis of the imaging examinations and the clinical assessment.
During this meeting, the imaging core lab and the experts will give their opinion on the feasibility of the endovascular procedure.
The criteria considered for ineligibility for surgery will include
- Comorbidities
- Complications (rhythm disorders, heart failure, pulmonary hypertension).
- Age of the patient
- Anatomical considerations
The criteria considered for eligibility for percutaneous treatment are:
- Ineligibility for surgery
- An adult patient with a compatible anatomy (distance between the upper edge of the anomalous pulmonary venous return and the lower edge of the innominate venous trunk > 2cm allowing sufficient stent attachment in the SVD; a diameter of the atrial septal defect >10mm allowing redirection of flow from the anomalous pulmonary venous return to the left atrium without restriction and a position of the anomalous pulmonary veins allowing redirection of flow to the left atrium without obstruction by the stent in digital simulation). These 3 elements will be analysed on the injected scanner and then confirmed by the scanner simulation, the 3D printed model and the simulation of the procedure on an experimental test bench.
If the patient is eligible for the endovascular approach, a bench simulation of the endovascular procedure will be performed.
A simulation of the endovascular procedure is performed on a test bench in the hybrid room of the Marie Lannelongue Hospital. The test bench consists of a 3D model of the heart that corresponds exactly to the patient's anatomy, produced using CT images.
The simulation allows on the one hand to confirm the feasibility of transcatheter correction of SVD and on the other hand to define the characteristics in terms of diameter and length of the necessary devices (stent and balloons) for the procedure in order to have a personalized approach.
The simulation session will take place in the presence of the referring interventional cardiologists.
All patients, regardless of the mode of correction of SVD, will have the same follow-up at D7, 1 month, 6 months and then every year for 5 years with an echographic control and a clinical evaluation
- Being tested
- OPTIMUS covered stent, Surgical correction of a SVD
- Keywords
- congenital heart disease, sinus venosus, stent, surgery, comparative study, 3D printing, simulation, rare disease, optimus, catheterization
- Medical subject headings
- Atrial Septal Defect Sinus Venosus, Heart Defects, Congenital, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPTIMUS covered stentDevice
The procedure involves placement of a long and large balloon-expandable covered stent in the superior vena cava that tunnels the abnormal pulmonary venous return to the left atrium.
Surgical correction of a SVDProcedure or surgery
Under cardiopulmonary bypass and open heart surgery, surgical correction of SVD either using single patch, double patch or Warden techniques
| Study group | Role | What they receive |
|---|---|---|
| endovascular | Experimental | Transcatheter correction of a SVD with an OPTIMUS covered stent Receives: Device: OPTIMUS covered stent |
| surgery | Active comparator | Surgical correction of a SVD Receives: Procedure: Surgical correction of a SVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants meeting the primary net criteria in the 2 groups
Number of participants (%) with complete occlusion of the shunt AND absence of a major procedure-related event (death or open-heart surgery).
Measured: At six month
Secondary outcomes (8)
Number of participants meeting the Safety and technical success criteria at 1 month
- Number of participants (%) with Technical success rate of the correction procedure defined by correction of Abnormal Pulmonary Venous Return and shunt occlusion AND absence of each of the following complications: ECMO, dialysis, stroke, rhythm disorder requiring drug or electrical intervention, severe conduction disorder requiring pace maker AND absence of re-hospitalization or prolongation of initial hospitalization due to a procedure-related Serious Adverse Event
Measured: At one month
Difference in functional capacity before versus after intervention
Change in baseline and 6-month 6 minutes walking test (in meters)
Measured: At six months
Difference in NYHA status before versus after intervention
Change in baseline and 6-month NYHA score (score from 0 to 4 O the best status 4 the worst functional class)
Measured: At six months
Number of participants meeting the safety criteria at one year
Number of participants (%) with percutaneous or surgical re-intervention, or stroke or conduction rhythm disorder requiring pacemaker placement.
Measured: At one year
Number of participants meeting the safety criteria at 2 years
Number of participants (%) with percutaneous or surgical re-intervention, or stroke or conduction rhythm disorder requiring pacemaker placement.
Measured: At two years
Number of participants meeting the safety criteria at three years
Number of participants (%) with major complications related to the heart disease
Measured: At three years
Number of participants meeting the safety criteria at four years
Number of participants (%) with major complications related to the heart disease
Measured: At four years
Number of participants meeting the safety criteria at five years
Number of participants (%) with major complications related to the heart disease
Measured: At five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start12 May 2023
- Primary completion12 May 2024 (estimated)
- Study completion12 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Sinus Venosus DefectStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Chirurgical Marie Lannelongue
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastien HASCOËT, Principal investigator, Hôpital Marie LannelongueAlban-Elouen BARUTEAU, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865119
- Sponsor's protocol ID
- 2022-A01507-36
- Acronym
- OPTIVENOSUS
- Status last verified
- Aug 2023
- First submitted
- 14 Mar 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Batteux C, Azarine A, Karsenty C, Petit J, Ciobotaru V, Brenot P, Hascoet S. Sinus Venosus ASDs: Imaging and Percutaneous Closure. Curr Cardiol Rep. 2021 Aug 19;23(10):138. doi: 10.1007/s11886-021-01571-7.
PubMed 34410510Batteux C, Ciobotaru V, Bouvaist H, Kempny A, Fraisse A, Hascoet S. Multicenter experience of transcatheter correction of superior sinus venosus defect using the covered Optimus XXL stent. Rev Esp Cardiol (Engl Ed). 2023 Mar;76(3):199-201. doi: 10.1016/j.rec.2022.08.004. Epub 2022 Aug 30. No abstract available. English, Spanish.
PubMed 36055641Rosenthal E, Qureshi SA, Jones M, Butera G, Sivakumar K, Boudjemline Y, Hijazi ZM, Almaskary S, Ponder RD, Salem MM, Walsh K, Kenny D, Hascoet S, Berman DP, Thomson J, Vettukattil JJ, Zahn EM. Correction of sinus venosus atrial septal defects with the 10 zig covered Cheatham-platinum stent - An international registry. Catheter Cardiovasc Interv. 2021 Jul 1;98(1):128-136. doi: 10.1002/ccd.29750. Epub 2021 May 7.
PubMed 33909945Batteux C, Meliani A, Brenot P, Hascoet S. Multimodality fusion imaging to guide percutaneous sinus venosus atrial septal defect closure. Eur Heart J. 2020 Dec 7;41(46):4444-4445. doi: 10.1093/eurheartj/ehaa292. No abstract available.
PubMed 32428931Haddad RN, Bonnet D, Gewillig M, Malekzadeh-Milani S. Modified safety techniques for transcatheter repair of superior sinus venosus defects with partial anomalous pulmonary venous drainage using a 100-mm Optimus-CVS(R) covered XXL stent. Catheter Cardiovasc Interv. 2022 Apr;99(5):1558-1562. doi: 10.1002/ccd.30136. Epub 2022 Feb 22.
PubMed 35192742Baruteau AE, Jones MI, Butera G, Qureshi SA, Rosenthal E. Transcatheter correction of sinus venosus atrial septal defect with partial anomalous pulmonary venous drainage: The procedure of choice in selected patients? Arch Cardiovasc Dis. 2020 Feb;113(2):92-95. doi: 10.1016/j.acvd.2019.09.014. Epub 2020 Feb 11. No abstract available.
PubMed 32057661Batteux C, Ciobotaru V, Haddad RN, Houeijeh A, Karsenty C, Bouzguenda I, Roussin R, Combes N, Bakloul M, Aldebert P, Dion F, Lefort B, Bosser G, Bonnet D, Fraisse A, Bouvaist H, Hoerer J, Moceri P, Godart F, Lenoir M, Dauphin C, Radojevic J, Thambo JB, Lecerf F, Hache O, Chevalier D, Beaussier H, Aubrege L, Azarine A, Decante B, Chatellier G, Ladouceur M, Baruteau AE, Henaine R, Albenque G, Hascoet S. Safety and efficacy of transcatheter correction of sinus venosus defect using 70-100mm-long partially covered Optimus-CVS(R) XXL stents compared with surgery: The OPTIVENOSUS study design. Arch Cardiovasc Dis. 2025 Sep;118(8-9):497-507. doi: 10.1016/j.acvd.2025.05.003. Epub 2025 May 29.
PubMed 40571458
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTImal Treatment of Sinus VENOSUS Defect - Efficacy and Safety of Transcatheter Correction Compared to Surgical Treatment in Patients With Sinus Venosus Defect
- ClinicalTrials.gov ID
- NCT05865119
- Acronym / sponsor ID
- OPTIVENOSUS / 2022-A01507-36
- Keywords
- congenital heart disease, sinus venosus, stent, surgery, comparative study, 3D printing, simulation, rare disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Chirurgical Marie LannelongueUniversity, hospital or other
- Study start
- 12 May 2023 (actual)
- Primary completion
- 12 May 2024 (estimated)
- Study completion
- 12 May 2029 (estimated)
- First posted
- 18 May 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.
Sinus venosus defect (SVD) accounts for 10% of atrial septal defects and is characterized by an anomalous pulmonary venous return in the superior vena cava associated with a high situated atrial septal defect. Since 2013, transcatheter correction of this congenital heart disease has emerged as a new treatment option. The procedure involves placement of a covered stent in the superior vena cava that tunnels the anomalous pulmonary venous return to the left atrium. Preliminary results are limited but promising.
The devices to be used depend on anatomic considerations. XXL stents than 70mm are often required. Today, the availability of CE marked stents is limited. There have been recent reports of successful corrections with the specifically developed Optimus XXL 100mm covered stent (ANDRATEC) with compassionate approval from the Agence Nationale de Sûreté du Médicament in France. Setting up a feasibility study to investigate the use of medical devices in this indication was required.
The objective of this project is to study the feasibility, efficacy and safety of the Optimus stent in this newly developed transcatheter procedure, in comparison with the gold-standard surgical method. A French national multicenter comparative cohort study including all eligible patients referred for transcatheter correction of SVD was designed. The feasibility of the transcatheter procedures will be investigated beforehand by virtual digital simulation and simulation on a 3D printed model. The procedures will then be performed in centers of the M3C network for complex congenital heart diseases (CARDIOGEN). The primary endpoint will be a composite of efficacy, defined as complete occlusion of the shunt, and safety, defined as the absence of major events at 6 months. The secondary endpoints will be anatomical, functional and psychosocial (quality of life).
It is expected that transcatheter treatment gives comparable results to surgery on the primary endpoint. This could justify the further development of this procedure as an alternative to surgery and facilitate the validation of dedicated equipment.
Detailed description
OPTIVENOSUS will be offered to patients who have an correction of SVD. A pre-therapeutic assessment will be prescribed with a CT scan and MRI, followed by a complementary assessment with a 6-minute walk test, a functional cardiorespiratory examination, a Holter and an ECG.
In addition, the images from the CT scan carried out during the pre-therapeutic assessment will be transferred to a secure platform approved for hosting health data. These images will be the subject of a 3D reconstruction.
Then a multidisciplinary consultation meeting held by paediatric cardiologists, specialists in adult congenital heart disease, surgeons and interventional cardiologists will be held to assess whether or not the patient is ineligible for surgery and whether or not the patient is eligible for transcatheter correction of SVD on the basis of the imaging examinations and the clinical assessment.
During this meeting, the imaging core lab and the experts will give their opinion on the feasibility of the endovascular procedure.
The criteria considered for ineligibility for surgery will include
- Comorbidities
- Complications (rhythm disorders, heart failure, pulmonary hypertension).
- Age of the patient
- Anatomical considerations
The criteria considered for eligibility for percutaneous treatment are:
- Ineligibility for surgery
- An adult patient with a compatible anatomy (distance between the upper edge of the anomalous pulmonary venous return and the lower edge of the innominate venous trunk > 2cm allowing sufficient stent attachment in the SVD; a diameter of the atrial septal defect >10mm allowing redirection of flow from the anomalous pulmonary venous return to the left atrium without restriction and a position of the anomalous pulmonary veins allowing redirection of flow to the left atrium without obstruction by the stent in digital simulation). These 3 elements will be analysed on the injected scanner and then confirmed by the scanner simulation, the 3D printed model and the simulation of the procedure on an experimental test bench.
If the patient is eligible for the endovascular approach, a bench simulation of the endovascular procedure will be performed.
A simulation of the endovascular procedure is performed on a test bench in the hybrid room of the Marie Lannelongue Hospital. The test bench consists of a 3D model of the heart that corresponds exactly to the patient's anatomy, produced using CT images.
The simulation allows on the one hand to confirm the feasibility of transcatheter correction of SVD and on the other hand to define the characteristics in terms of diameter and length of the necessary devices (stent and balloons) for the procedure in order to have a personalized approach.
The simulation session will take place in the presence of the referring interventional cardiologists.
All patients, regardless of the mode of correction of SVD, will have the same follow-up at D7, 1 month, 6 months and then every year for 5 years with an echographic control and a clinical evaluation
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endovascular | Experimental | Device: OPTIMUS covered stentTranscatheter correction of a SVD with an OPTIMUS covered stent |
| surgery | Active comparator | Procedure: Surgical correction of a SVDSurgical correction of a SVD |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- from 12 years of age
- SVD with right ventricular end-diastolic volume dilatation (RV EDV) on imaging (echocardiography and/or MRI), defined by the guidelines as RV EDV greater than 112mL/m2 for women and 121 mL/m2 for men.
- With an indication for atrial septal defect correction, indicated at a medical-surgical meeting according to the ESC 2020 guideline criteria
- Adult patients who received informed information about the study and signed a consent to participate in the study
- Minor patients, no opposition from both holders of parental authority to data processing.
Key exclusion criteria (5 listed)
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under judicial protection
- Pregnant or breastfeeding woman
- Patient already included in an interventional research protocol
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 |
|---|---|---|
| OPTIMUS covered stentThe procedure involves placement of a long and large balloon-expandable covered stent in the superior vena cava that tunnels the abnormal pulmonary venous return to the left atrium. | Device | endovascular |
| Surgical correction of a SVDUnder cardiopulmonary bypass and open heart surgery, surgical correction of SVD either using single patch, double patch or Warden techniques | Procedure or surgery | surgery |
Primary outcome
Number of participants meeting the primary net criteria in the 2 groups
Time frame: At six month
Number of participants (%) with complete occlusion of the shunt AND absence of a major procedure-related event (death or open-heart surgery).
8 secondary outcomes
Number of participants meeting the Safety and technical success criteria at 1 month
Time frame: At one month
Difference in functional capacity before versus after intervention
Time frame: At six months
Difference in NYHA status before versus after intervention
Time frame: At six months
Number of participants meeting the safety criteria at one year
Time frame: At one year
Number of participants meeting the safety criteria at 2 years
Time frame: At two years
Number of participants meeting the safety criteria at three years
Time frame: At three years
Number of participants meeting the safety criteria at four years
Time frame: At four years
Number of participants meeting the safety criteria at five years
Time frame: At five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Background: PubMed 34410510Batteux C, Azarine A, Karsenty C, Petit J, Ciobotaru V, Brenot P, Hascoet S. Sinus Venosus ASDs: Imaging and Percutaneous Closure. Curr Cardiol Rep. 2021 Aug 19;23(10):138. doi: 10.1007/s11886-021-01571-7.
- Background: PubMed 36055641Batteux C, Ciobotaru V, Bouvaist H, Kempny A, Fraisse A, Hascoet S. Multicenter experience of transcatheter correction of superior sinus venosus defect using the covered Optimus XXL stent. Rev Esp Cardiol (Engl Ed). 2023 Mar;76(3):199-201. doi: 10.1016/j.rec.2022.08.004. Epub 2022 Aug 30. No abstract available. English, Spanish.
- Background: PubMed 33909945Rosenthal E, Qureshi SA, Jones M, Butera G, Sivakumar K, Boudjemline Y, Hijazi ZM, Almaskary S, Ponder RD, Salem MM, Walsh K, Kenny D, Hascoet S, Berman DP, Thomson J, Vettukattil JJ, Zahn EM. Correction of sinus venosus atrial septal defects with the 10 zig covered Cheatham-platinum stent - An international registry. Catheter Cardiovasc Interv. 2021 Jul 1;98(1):128-136. doi: 10.1002/ccd.29750. Epub 2021 May 7.
- Background: PubMed 32428931Batteux C, Meliani A, Brenot P, Hascoet S. Multimodality fusion imaging to guide percutaneous sinus venosus atrial septal defect closure. Eur Heart J. 2020 Dec 7;41(46):4444-4445. doi: 10.1093/eurheartj/ehaa292. No abstract available.
- Background: PubMed 35192742Haddad RN, Bonnet D, Gewillig M, Malekzadeh-Milani S. Modified safety techniques for transcatheter repair of superior sinus venosus defects with partial anomalous pulmonary venous drainage using a 100-mm Optimus-CVS(R) covered XXL stent. Catheter Cardiovasc Interv. 2022 Apr;99(5):1558-1562. doi: 10.1002/ccd.30136. Epub 2022 Feb 22.
- Background: PubMed 32057661Baruteau AE, Jones MI, Butera G, Qureshi SA, Rosenthal E. Transcatheter correction of sinus venosus atrial septal defect with partial anomalous pulmonary venous drainage: The procedure of choice in selected patients? Arch Cardiovasc Dis. 2020 Feb;113(2):92-95. doi: 10.1016/j.acvd.2019.09.014. Epub 2020 Feb 11. No abstract available.
- Derived from this study: PubMed 40571458Batteux C, Ciobotaru V, Haddad RN, Houeijeh A, Karsenty C, Bouzguenda I, Roussin R, Combes N, Bakloul M, Aldebert P, Dion F, Lefort B, Bosser G, Bonnet D, Fraisse A, Bouvaist H, Hoerer J, Moceri P, Godart F, Lenoir M, Dauphin C, Radojevic J, Thambo JB, Lecerf F, Hache O, Chevalier D, Beaussier H, Aubrege L, Azarine A, Decante B, Chatellier G, Ladouceur M, Baruteau AE, Henaine R, Albenque G, Hascoet S. Safety and efficacy of transcatheter correction of sinus venosus defect using 70-100mm-long partially covered Optimus-CVS(R) XXL stents compared with surgery: The OPTIVENOSUS study design. Arch Cardiovasc Dis. 2025 Sep;118(8-9):497-507. doi: 10.1016/j.acvd.2025.05.003. Epub 2025 May 29.
- Baruteau AE, Jones MI, Butera G, Qureshi SA, Rosenthal E. Transcatheter correction of sinus venosus atrial septal defect with partial anomalous pulmonary venous drainage: The procedure of choice in selected patients? Arch Cardiovasc Dis. 2020Link provided by the sponsor.
- Batteux C, Azarine A, Karsenty C, Petit J, Ciobotaru V, Brenot P, Hascoet S. Sinus Venosus ASDs: Imaging and Percutaneous Closure. Curr Cardiol Rep. 2021 Aug 19;23(10):138. doi: 10.1007/s11886-021-01571-7Link provided by the sponsor.
- Batteux C, Ciobotaru V, Bouvaist H, Kempny A, Fraisse A, Hascoet S. Multicenter experience of transcatheter correction of superior sinus venosus defect using the covered Optimus XXL stent. Rev Esp Cardiol (Engl Ed). 2023 Mar;76(3):199-201.Link provided by the sponsor.
- Rosenthal E, Qureshi SA, Jones M, Butera G, Sivakumar K, Boudjemline Y, Hijazi ZM, Almaskary S, Ponder RD, Salem MM, Walsh K, Kenny D, Hascoet S, Berman DP, Thomson J, Vettukattil JJ, Zahn EM. Correction of sinus venosus atrial septal defects with the 10Link provided by the sponsor.
- Batteux C, Meliani A, Brenot P, Hascoet S. Multimodality fusion imaging to guide percutaneous sinus venosus atrial septal defect closure. Eur Heart J. 2020 Dec 7;41(46):4444-4445. doi: 10.1093/eurheartj/ehaa292. No abstract available.Link provided by the sponsor.
- Haddad RN, Bonnet D, Gewillig M, Malekzadeh-Milani S. Modified safety techniques for transcatheter repair of superior sinus venosus defects with partial anomalous pulmonary venous drainage using a 100-mm Optimus-CVS(R) covered XXL stent.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Sebastien HASCOËT principal investigator
Hôpital Marie Lannelongue
Alban-Elouen BARUTEAU principal investigator
Nantes University Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPTIMUS covered stent and Surgical correction of a SVD in people with Sinus Venosus Defect and Congenital Heart Disease, run by Centre Chirurgical Marie Lannelongue at 13 sites in France.
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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SEBASTIEN HASCOËT (+33140942429, s.hascoet@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants meeting the primary net criteria in the 2 groups (time frame: At six month). 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 NCT05865119, which also lists 7 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 14 Aug 2023.