OPTImal Treatment of Sinus VENOSUS Defect (OPTIVENOSUS)

August 9, 2023 updated by: Centre Chirurgical Marie Lannelongue

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France, 33404
      • Bron, France, 69500
        • Not yet recruiting
        • Hospices Civils de Lyon
        • Contact:
        • Principal Investigator:
          • Mohamed BAKLOUL
      • Clermont-Ferrand, France, 63000
        • Not yet recruiting
        • Chu Clermont-Ferrand
        • Contact:
          • Claire Dauphin
        • Principal Investigator:
          • Claire DAUPHIN
      • Grenoble, France, 38700
        • Recruiting
        • CHU Grenoble
        • Contact:
        • Principal Investigator:
          • Helene BOUVAIST
      • Le Plessis-Robinson, France, 92350
        • Recruiting
        • Sébastien HASCOËT
        • Contact:
        • Principal Investigator:
          • Clément BATTEUX
      • Lille, France, 59000
      • Marseille, France, 13385
        • Not yet recruiting
        • Hôpitaux universitaire de Marseille
        • Principal Investigator:
          • Caroline Ovaert
        • Contact:
      • Nantes, France, 44000
      • Paris, France, 75015
        • Not yet recruiting
        • CHU Necker APHP Paris
        • Contact:
        • Principal Investigator:
          • Sophie MALEKZADEH
      • Paris, France, 75015
        • Not yet recruiting
        • HEGP Paris
        • Contact:
        • Principal Investigator:
          • Sophie MALEKZADEH
      • Toulouse, France, 31300
        • Not yet recruiting
        • CHU Toulouse
        • Principal Investigator:
          • Clément Karsenty
        • Contact:
          • Clément KARSENTY
      • Toulouse, France, 31300
        • Not yet recruiting
        • Clinique Pasteur, Toulouse
        • Contact:
        • Principal Investigator:
          • Nicolas COMBES
      • Tours, France, 37000
        • Not yet recruiting
        • Chu Tours
        • Principal Investigator:
          • Bruno Lefort
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: endovascular
Transcatheter correction of a SVD with an OPTIMUS covered stent
Device: OPTIMUS covered stent
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.
Active Comparator: surgery
Surgical correction of a SVD
Procedure: Surgical correction of a SVD
Under cardiopulmonary bypass and open heart surgery, surgical correction of SVD either using single patch, double patch or Warden techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
At six month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants meeting the Safety and technical success criteria at 1 month
Time Frame: At one 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
At one month
Difference in functional capacity before versus after intervention
Time Frame: At six months
Change in baseline and 6-month 6 minutes walking test (in meters)
At six months
Difference in NYHA status before versus after intervention
Time Frame: At six months
Change in baseline and 6-month NYHA score (score from 0 to 4 O the best status 4 the worst functional class)
At six months
Number of participants meeting the safety criteria at one year
Time Frame: At one year
Number of participants (%) with percutaneous or surgical re-intervention, or stroke or conduction rhythm disorder requiring pacemaker placement.
At one year
Number of participants meeting the safety criteria at 2 years
Time Frame: At two years
Number of participants (%) with percutaneous or surgical re-intervention, or stroke or conduction rhythm disorder requiring pacemaker placement.
At two years
Number of participants meeting the safety criteria at three years
Time Frame: At three years
Number of participants (%) with major complications related to the heart disease
At three years
Number of participants meeting the safety criteria at four years
Time Frame: At four years
Number of participants (%) with major complications related to the heart disease
At four years
Number of participants meeting the safety criteria at five years
Time Frame: At five years
Number of participants (%) with major complications related to the heart disease
At five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Chirurgical Marie Lannelongue

Investigators

  • Principal Investigator: Sebastien HASCOËT, Hopital Marie Lannelongue
  • Principal Investigator: Alban-Elouen BARUTEAU, CHU Nantes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2023

Primary Completion (Estimated)

May 12, 2024

Study Completion (Estimated)

May 12, 2029

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

May 17, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-A01507-36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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