Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® mVSD Cases

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Brief Title

Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® mVSD Cases

Official Title

A Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® Muscular Ventricular Septal Defect (mVSD) Occluder in Patients With Muscular Ventricular Septal Defects

Brief Summary

      The Occlutech® mVSD is indicated for percutaneous, transcatheter muscular ventricular septal
      defect closure device designed for the occlusion of hemodynamically significant muscular
      ventricular septal defects.

      The objectives of the study are:

        -  To confirm the efficacy of Occlutech mVSD in patients requiring transcatheter occlusion
           (closure) of muscular ventricular septal defects.

        -  To confirm the safety of Occlutech mVSD in patients requiring transcatheter occlusion
           (closure) of muscular ventricular septal defects.
    

Detailed Description

      This is a multicenter, International, follow-up registry to monitor the efficacy and safety
      of the Occlutech® mVSD in patients with muscular ventricular septal defects.

        -  Efficacy and safety of implanted device(s) will be assessed by vital signs, laboratory
           test, ECGs, and echocardiography on Day 1 (within 36 hrs. post procedure), Day 30, day
           60, 6 months and 1 year after the implantation.

        -  Patients will be treated according to the instruction-for-use of the device and
           according to clinical routine

        -  Patients will be screened to determine eligibility for the registry based on
           inclusion/exclusion criteria, through their medical history, demographics, vital signs,
           clinical laboratory tests, performance of a 12 lead electrocardiogram (ECG) and
           echocardiography data.

        -  Procedures will be performed at sites having appropriate laboratory support and
           adequately trained imaging personnel. Procedure will be performed by physicians with
           experience in a wide range of interventional cardiology and structural heart disease,
           including transseptal puncture, anterograde, retrograde or transapical device delivery
           approaches.

      Registry will be open for the next two years or when up to 100 patients are enrolled
      (whatever comes first)

      The primary efficacy endpoints will include data obtained 1 year after mVSD closure procedure
      for successful implantation of the device with a proper closure of the mVSD (defined as
      Reduction in muscular ventricular septal regurgitation of ≥ one grade as assessed by
      echocardiography pre vs post implantation) and/or reduction in the number of hemolysis
      related transfusions.

      The primary safety endpoint is defined as absence of Serious Adverse Events (SAEs) 1 years
      after mVSD closure procedure.
    


Study Type

Observational [Patient Registry]


Primary Outcome

The primary safety endpoint


Condition

Muscular Ventricular Septal Defect

Intervention

muscular ventricular septal defects

Study Arms / Comparison Groups

 muscular ventricular septal defects
Description:  patients with muscular ventricular septal defects

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

100

Start Date

March 3, 2022

Completion Date

October 1, 2029

Primary Completion Date

March 3, 2023

Eligibility Criteria

        Inclusion Criteria:

        A patient will be eligible for study participation if he/she meets the indication and area
        of application as laid down in the IFU. Thus, the Occlutech® mVSD is indicated
        percutaneous, transcatheter muscular ventricular septal defect closure and who are deemed
        at high risk for surgical intervention after consultation with surgical physicians or as an
        alternative to surgery with less operational time and recovery period.

        Exclusion Criteria:

        The device is contraindicated for patients known to have any of the following:

          -  An aortic rim of less than 2 mm

          -  Patients weighing less than 5.0 kg

          -  Sepsis (local or generalized)

          -  Perimembranous VSD or post-MI VSD

          -  Recent myocardial infarction or a surgical bypass operation in the last 30 days

          -  History of repeated pulmonary infection

          -  Any type of serious infection 1 month prior to procedure

          -  Malignancy where life expectancy is less than 3 years

          -  Demonstrated intracardiac thrombi on echocardiography

          -  Allergy to anti-platelet or anticoagulant therapy

          -  Allergy to nickel and/or titanium and/or nickel/titanium-based materials

          -  Intolerance to contrast agents

          -  Active bacterial infection
      

Gender

All

Ages

3 Months - 80 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Turkey

Location Countries

Turkey

Administrative Informations


NCT ID

NCT05329350

Organization ID

Occ2016_07


Responsible Party

Sponsor

Study Sponsor

Occlutech International AB


Study Sponsor

, , 


Verification Date

April 2022