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OPTImal Treatment of Sinus VENOSUS Defect (OPTIVENOSUS)

Primary Purpose

Sinus Venosus Defect, Congenital Heart Disease, Sinus Venosus Atrial Septum Defect

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
OPTIMUS covered stent
Surgical correction of a SVD
Sponsored by
Centre Chirurgical Marie Lannelongue
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sinus Venosus Defect focused on measuring congenital heart disease, sinus venosus, stent, surgery, comparative study, 3D printing, simulation, rare disease, optimus, catheterization

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • CHU Bordeaux
  • Hospices Civils de Lyon
  • CHU Clermont-Ferrand
  • CHU GrenobleRecruiting
  • Sébastien HASCOËTRecruiting
  • CHU LilleRecruiting
  • Hôpitaux universitaire de Marseille
  • CHU Nantes
  • CHU Necker APHP Paris
  • HEGP Paris
  • CHU Toulouse
  • Clinique Pasteur, Toulouse
  • CHU Tours

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

endovascular

surgery

Arm Description

Transcatheter correction of a SVD with an OPTIMUS covered stent

Surgical correction of a SVD

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
Difference in functional capacity before versus after intervention
Change in baseline and 6-month 6 minutes walking test (in meters)
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)
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.
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.
Number of participants meeting the safety criteria at three years
Number of participants (%) with major complications related to the heart disease
Number of participants meeting the safety criteria at four years
Number of participants (%) with major complications related to the heart disease
Number of participants meeting the safety criteria at five years
Number of participants (%) with major complications related to the heart disease

Full Information

First Posted
March 14, 2023
Last Updated
August 9, 2023
Sponsor
Centre Chirurgical Marie Lannelongue
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1. Study Identification

Unique Protocol Identification Number
NCT05865119
Brief Title
OPTImal Treatment of Sinus VENOSUS Defect
Acronym
OPTIVENOSUS
Official Title
OPTImal Treatment of Sinus VENOSUS Defect - Efficacy and Safety of Transcatheter Correction Compared to Surgical Treatment in Patients With Sinus Venosus Defect
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2023 (Actual)
Primary Completion Date
May 12, 2024 (Anticipated)
Study Completion Date
May 12, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Chirurgical Marie Lannelongue

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinus Venosus Defect, Congenital Heart Disease, Sinus Venosus Atrial Septum Defect
Keywords
congenital heart disease, sinus venosus, stent, surgery, comparative study, 3D printing, simulation, rare disease, optimus, catheterization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
endovascular
Arm Type
Experimental
Arm Description
Transcatheter correction of a SVD with an OPTIMUS covered stent
Arm Title
surgery
Arm Type
Active Comparator
Arm Description
Surgical correction of a SVD
Intervention Type
Device
Intervention Name(s)
OPTIMUS covered stent
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Surgical correction of a SVD
Intervention Description
Under cardiopulmonary bypass and open heart surgery, surgical correction of SVD either using single patch, double patch or Warden techniques
Primary Outcome Measure Information:
Title
Number of participants meeting the primary net criteria in the 2 groups
Description
Number of participants (%) with complete occlusion of the shunt AND absence of a major procedure-related event (death or open-heart surgery).
Time Frame
At six month
Secondary Outcome Measure Information:
Title
Number of participants meeting the Safety and technical success criteria at 1 month
Description
- 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
Time Frame
At one month
Title
Difference in functional capacity before versus after intervention
Description
Change in baseline and 6-month 6 minutes walking test (in meters)
Time Frame
At six months
Title
Difference in NYHA status before versus after intervention
Description
Change in baseline and 6-month NYHA score (score from 0 to 4 O the best status 4 the worst functional class)
Time Frame
At six months
Title
Number of participants meeting the safety criteria at one year
Description
Number of participants (%) with percutaneous or surgical re-intervention, or stroke or conduction rhythm disorder requiring pacemaker placement.
Time Frame
At one year
Title
Number of participants meeting the safety criteria at 2 years
Description
Number of participants (%) with percutaneous or surgical re-intervention, or stroke or conduction rhythm disorder requiring pacemaker placement.
Time Frame
At two years
Title
Number of participants meeting the safety criteria at three years
Description
Number of participants (%) with major complications related to the heart disease
Time Frame
At three years
Title
Number of participants meeting the safety criteria at four years
Description
Number of participants (%) with major complications related to the heart disease
Time Frame
At four years
Title
Number of participants meeting the safety criteria at five years
Description
Number of participants (%) with major complications related to the heart disease
Time Frame
At five years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SEBASTIEN HASCOËT
Phone
+33140942429
Email
s.hascoet@ghpsj.fr
First Name & Middle Initial & Last Name or Official Title & Degree
FLORENCE LECERF
Phone
+33140942517
Email
f.lecerf@ghpsj.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastien HASCOËT
Organizational Affiliation
Hôpital Marie Lannelongue
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alban-Elouen BARUTEAU
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Bordeaux
City
Bordeaux
ZIP/Postal Code
33404
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Benoit THAMBO
Email
jean-benoit.thambo@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Jean-Benoit THAMBO
Facility Name
Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69500
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed BAKLOUL
Email
mohamed.bakloul@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Mohamed BAKLOUL
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire DAUPHIN
First Name & Middle Initial & Last Name & Degree
Claire DAUPHIN
Facility Name
CHU Grenoble
City
Grenoble
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hélène BOUVAIST
Email
hbouvaist@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Helene BOUVAIST
Facility Name
Sébastien HASCOËT
City
Le Plessis-Robinson
ZIP/Postal Code
92350
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien HASCOËT
Email
s.hascoet@ghpsj.fr
First Name & Middle Initial & Last Name & Degree
Clément BATTEUX
Facility Name
CHU Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François GODART
Email
francois.godart@chru-lille.fr
First Name & Middle Initial & Last Name & Degree
François GODART
Facility Name
Hôpitaux universitaire de Marseille
City
Marseille
ZIP/Postal Code
13385
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline OVAERT
Email
caroline.ovaert@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Caroline OVAERT
Facility Name
CHU Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alban-Elouen BARUTEAU
Email
albanelouen.baruteau@chu-nantes.fr
First Name & Middle Initial & Last Name & Degree
Alban-Elouen BARUTEAU
Facility Name
CHU Necker APHP Paris
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie MALEKZADEH
Email
Sophie.malekzadeh@aphp.fr
First Name & Middle Initial & Last Name & Degree
Sophie MALEKZADEH
Facility Name
HEGP Paris
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie MALEKZADEH
Email
Sophie.malekzadeh@aphp.fr
First Name & Middle Initial & Last Name & Degree
Sophie MALEKZADEH
Facility Name
CHU Toulouse
City
Toulouse
ZIP/Postal Code
31300
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clément KARSENTY
First Name & Middle Initial & Last Name & Degree
Clément KARSENTY
Facility Name
Clinique Pasteur, Toulouse
City
Toulouse
ZIP/Postal Code
31300
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas COMBES
Email
n.combes@clinique-pasteur.com
First Name & Middle Initial & Last Name & Degree
Nicolas COMBES
Facility Name
CHU Tours
City
Tours
ZIP/Postal Code
37000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno LEFORT
Email
b.lefort@univ-tours.fr
First Name & Middle Initial & Last Name & Degree
Bruno LEFORT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34410510
Citation
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.
Results Reference
background
PubMed Identifier
36055641
Citation
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. doi: 10.1016/j.rec.2022.08.004. Epub 2022 Aug 30. No abstract available. English, Spanish.
Results Reference
background
PubMed Identifier
33909945
Citation
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 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.
Results Reference
background
PubMed Identifier
32428931
Citation
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.
Results Reference
background
PubMed Identifier
35192742
Citation
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. Catheter Cardiovasc Interv. 2022 Apr;99(5):1558-1562. doi: 10.1002/ccd.30136. Epub 2022 Feb 22.
Results Reference
background
PubMed Identifier
32057661
Citation
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. 2020 Feb;113(2):92-95. doi: 10.1016/j.acvd.2019.09.014. Epub 2020 Feb 11. No abstract available.
Results Reference
background
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/32057661/
Description
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. 2020
URL
https://pubmed.ncbi.nlm.nih.gov/34410510/
Description
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
URL
https://pubmed.ncbi.nlm.nih.gov/36055641/
Description
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.
URL
https://pubmed.ncbi.nlm.nih.gov/33909945/
Description
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 10
URL
https://pubmed.ncbi.nlm.nih.gov/32428931/
Description
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.
URL
https://pubmed.ncbi.nlm.nih.gov/35192742/
Description
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.

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OPTImal Treatment of Sinus VENOSUS Defect

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