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A Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® PmVSD Occluder in Patients With Perimembranous Ventricular Septal Defects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04034498
Recruitment Status : Recruiting
First Posted : July 26, 2019
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Occlutech International AB

Brief Summary:
The objective of this registry is to gain more insight on the clinical use of the Occlutech perimembranous VSD occluder.

Condition or disease
Perimembranous Ventricular Septal Defect

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration: 5 Years
Official Title: A Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® Perimembranous Ventricular Septal Defect (PmVSD) Occluder in Patients With Perimembranous Ventricular Septal Defects
Actual Study Start Date : July 7, 2019
Estimated Primary Completion Date : June 2026
Estimated Study Completion Date : July 2026

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. To confirm the efficacy of Occlutech PmVSD in patients requiring transcatheter occlusion (closure) of perimembranous ventricular septal defects. [ Time Frame: 1 year following implantation ]
    The primary efficacy endpoint is defined as successful implantation of the device with a proper closure of the pmVSD (defined as reduction in VSD shunt of more than one grade as assessed by TTE post implantation).

  2. To confirm the safety of Occlutech PmVSD in patients requiring transcatheter occlusion (closure) of perimembranous ventricular septal defects. [ Time Frame: 1 year following implantation ]
    The primary safety endpoint is defined as absence of Serious Adverse Device Effects (SADEs) including procedure-related death, procedure-related stroke, systemic embolism, severe hemolysis, complete heart block requiring pacemaker implantation or device explantation, new-onset of severe tricuspid regurgitation (TR), new onset of severe aortic regurgitation (AR), device embolization, severe right-left ventricular outflow obstruction (RVOTO-LVOTO), cardiac tamponade, infective endocarditis or vascular complications requiring surgery.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
There will be no pre-selection of patients for enrollment in this registry. The criteria provided in the Instructions For Use should be followed. The study cohort will thus consist of consecutively enrolled patients at the discretion of the treating physician
Criteria

Inclusion Criteria:

Patients with haemodynamically significant perimembranous defects which are located in the ventricular septum

Exclusion Criteria:

Occlutech® PmVSD Occluder is contraindicated for the following:

  • Patients with defects less than 2 mm aortic rim and/or interference with the aortic or atrioventricular valves
  • Patients less than 10.0 kg
  • Patients with sepsis (local or generalized)
  • Patients with left ventricle to right atrial shunting
  • Patients with right to left shunting through the defect
  • Patients with PmVSD with an aneurysm and multiple shunts that could not be successfully closed with one device
  • Patients with complex heart lesions such as tetralogy of fallot
  • 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
  • Patients with allergy to anti-platelet or anticoagulant therapy
  • Patients with allergy to nickel and/or titanium and/or nickel/titanium based materials
  • Patients with intolerance to contrast agents
  • Patients with active bacterial infections
  • Patients with very small vessels which are not suitable for recommended delivery sheath sizes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04034498


Contacts
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Contact: Gönül Sönmez Utkan +90 212465 0497 clinicaltrials@occlutech.com

Locations
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United States, Colorado
Childrens' Hospital of Colorado & University of Colorado Hospital Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Gareth J Morgan, MD         
Germany
Ludwig Maximilians University Not yet recruiting
Munich, Germany
Contact: Robert Dalla Pozza, Prof. Dr.         
Thailand
Queen Sirikit National Institute of Child Health Not yet recruiting
Bangkok, Thailand
Contact: Worakan Promphan, Dr.         
Prince of Songkla University Not yet recruiting
Hat Yai, Thailand
Contact: Supapron Roymanee, Dr.         
Vietnam
Children's Hospital 1 Recruiting
Ho Chi Minh City, Vietnam
Contact: Do Nguyen Tin, Dr.         
City Children Hospital Recruiting
Ho Chi Minh City, Vietnam
Contact: Tran Cong Bao Phung, Dr.         
University Medical Center HCMC Recruiting
Ho Chi Minh City, Vietnam
Contact: Dao Anh Quoc, Dr.         
Sponsors and Collaborators
Occlutech International AB
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Responsible Party: Occlutech International AB
ClinicalTrials.gov Identifier: NCT04034498    
Other Study ID Numbers: Occ2018-01
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Septal Defects
Heart Septal Defects, Ventricular
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities