OPTImal Treatment of Sinus VENOSUS Defect

NCT05865119 | Recruiting DMC

• 1 other identifier: 2022-A01507-36
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 13

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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).

  At six month

Secondary Outcomes (8)

• Number of participants meeting the Safety and technical success criteria at 1 month

  At one month

• Difference in functional capacity before versus after intervention

  At six months

• Difference in NYHA status before versus after intervention

  At six months

• Number of participants meeting the safety criteria at one year

  At one year

• Number of participants meeting the safety criteria at 2 years

  At two years

Study Arms (2)

endovascular

EXPERIMENTAL

Transcatheter correction of a SVD with an OPTIMUS covered stent

Device: OPTIMUS covered stent

surgery

ACTIVE COMPARATOR

Surgical correction of a SVD

Procedure: Surgical correction of a SVD

Interventions

OPTIMUS covered stent DEVICE

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.

endovascular

Surgical correction of a SVD PROCEDURE

Under cardiopulmonary bypass and open heart surgery, surgical correction of SVD either using single patch, double patch or Warden techniques

surgery

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Chirurgical Marie Lannelongue: lead

Study Sites (13)

CHU Bordeaux

Bordeaux, 33404, France

NOT YET RECRUITING

Hospices Civils de Lyon

Bron, 69500, France

NOT YET RECRUITING

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

NOT YET RECRUITING

CHU Grenoble

Grenoble, 38700, France

RECRUITING

Sébastien HASCOËT

Le Plessis-Robinson, 92350, France

RECRUITING

CHU Lille

Lille, 59000, France

RECRUITING

Hôpitaux universitaire de Marseille

Marseille, 13385, France

NOT YET RECRUITING

CHU Nantes

Nantes, 44000, France

NOT YET RECRUITING

CHU Necker APHP Paris

Paris, 75015, France

NOT YET RECRUITING

HEGP Paris

Paris, 75015, France

NOT YET RECRUITING

CHU Toulouse

Toulouse, 31300, France

NOT YET RECRUITING

Clinique Pasteur, Toulouse

Toulouse, 31300, France

NOT YET RECRUITING

CHU Tours

Tours, 37000, France

NOT YET RECRUITING

Related Publications (7)

• 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.

  PMID: 34410510 BACKGROUND

• 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.

  PMID: 36055641 BACKGROUND

• 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.

  PMID: 33909945 BACKGROUND

• 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.

  PMID: 32428931 BACKGROUND

• 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.

  PMID: 35192742 BACKGROUND

• 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.

  PMID: 32057661 BACKGROUND

• Batteux 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.

  PMID: 40571458 DERIVED

Related Links

• 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
• 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
• 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.
• 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
• 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.
• 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.

MeSH Terms

Conditions

Atrial Septal Defect Sinus Venosus; Heart Defects, Congenital; Rare Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sebastien HASCOËT

  Hôpital Marie Lannelongue

  PRINCIPAL INVESTIGATOR

• Alban-Elouen BARUTEAU

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SEBASTIEN HASCOËT

CONTACT

+33140942429; s.hascoet@ghpsj.fr

FLORENCE LECERF

CONTACT

+33140942517; f.lecerf@ghpsj.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: May 18, 2023
• Study Start: May 12, 2023
• Primary Completion: May 12, 2024
• Study Completion (Estimated): May 12, 2029
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (13)