An interventional study of OPTIMUS covered stent and Surgical correction of a SVD in Sinus Venosus Defect, Congenital Heart Disease and Sinus Venosus Atrial Septum Defect, sponsored by Centre Chirurgical Marie Lannelongue. Recruiting at 13 sites in France. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2023-08-14.
Sponsored by Centre Chirurgical Marie Lannelongue · Not applicable, Interventional, and Treatment
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.
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
The criteria considered for eligibility for percutaneous treatment are:
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
991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 507 interventional studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →Centre Chirurgical Marie Lannelongue is the lead sponsor of 40 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Transcatheter correction of a SVD with an OPTIMUS covered stent
Device: OPTIMUS covered stent
Surgical correction of a SVD
Procedure: Surgical correction of a SVD
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.
Under cardiopulmonary bypass and open heart surgery, surgical correction of SVD either using single patch, double patch or Warden techniques
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).
Time frame: At six month
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
Time frame: At one month
Difference in functional capacity before versus after intervention
Change in baseline and 6-month 6 minutes walking test (in meters)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: At two years
Number of participants meeting the safety criteria at three years
Number of participants (%) with major complications related to the heart disease
Time frame: At three years
Number of participants meeting the safety criteria at four years
Number of participants (%) with major complications related to the heart disease
Time frame: At four years
Number of participants meeting the safety criteria at five years
Number of participants (%) with major complications related to the heart disease
Time frame: At five years
Plan to share: No
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Centre Chirurgical Marie Lannelongue