NCT05865119: OPTIVENOSUS

OPTImal Treatment of Sinus VENOSUS Defect

Recruiting now NA Last updated 14 August 2023

What this trial tests

NA trial testing OPTIMUS covered stent in Sinus Venosus Defect in 60 participants. Currently enrolling.

Timeline

12 May 2023

Primary endpoint
12 May 2024

12 May 2029

Quick facts

Lead sponsor	Centre Chirurgical Marie Lannelongue
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	12 May 2023
Primary completion	12 May 2024
Estimated completion	12 May 2029
Sites	13 locations across France

Drugs / interventions tested

• OPTIMUS covered stent
• Surgical correction of a SVD

Conditions studied

• Sinus Venosus Defect — all drugs for Sinus Venosus Defect →
• Congenital Heart Disease — all drugs for Congenital Heart Disease →
• Sinus Venosus Atrial Septum Defect — all drugs for Sinus Venosus Atrial Septum Defect →

Sponsor

Centre Chirurgical Marie Lannelongue — full company profile →

Who can join

12 and older, any sex, with Sinus Venosus Defect or Congenital Heart Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Safety and efficacy of transcatheter correction of sinus venosus defect using 70-100mm-long partially covered Optimus-CVS® XXL stents compared with surgery: The OPTIVENOSUS study design.
   Batteux C, Ciobotaru V, Haddad RN, Houeijeh A, et al · · 2025 · cited 1× · PMID 40571458 · DOI 10.1016/j.acvd.2025.05.003