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Lifetech CeraFlex™ Post-Market Surveillance Study

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02621528
Recruitment Status : Completed
First Posted : December 3, 2015
Last Update Posted : March 13, 2020
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Lifetech Scientific (Shenzhen) Co., Ltd.

Study Description
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Brief Summary:
The purpose of this multi-center, non-interventional, prospective, post-market clinical study is to collect real world data on patient outcomes and evaluate the procedural success and performance of the Lifetech CeraFlex™ occluders for patients with secundum type Atrial Septum Defect (ASD), Patent Foramen Ovale (PFO) or Patent Ductus Arteriosus (PDA).

Condition or disease Intervention/treatment Phase
Patent Foramen Ovale Atrial Septal Defect Patent Ductus Arteriosus Device: CeraFlex Not Applicable

Detailed Description:

This study is designed as a post-market, prospective, multi-center, non-interventional clinical study to collect data regarding procedural success, clinical performance and cost-effectiveness of the Lifetech CeraFlex™ occluders in patients with secundum ASD, PFO and PDA.

Patients will be recruited in up to 12 investigational centers located in Europe and the Middle East.

To avoid bias in the study population the following measures will be taken:

  • All sponsor or designee and external study personnel will be trained on the latest version of the Clinical Investigation Plan (CIP) and related study materials.
  • Patients will be screened to confirm study eligibility with pre-defined inclusion/exclusion criteria prior to enrollment.
  • This study will follow consecutive screening and enrollment.

The study will enroll 120 patients. The patient population will consist of up to approximately 40 consecutive enrolled patients with a confirmed secundum type ASD, up to approximately 40 enrolled patients with PFO and up to approximately 40 enrolled patients with PDA resulting in a significant shunt and in need of an intervention. These estimated upper limits per therapy group can however be exceeded depending on the enrollment trend, to account for a minimum of 10 patients to be enrolled per therapy group and a total study population of 120 enrolled patients.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-center, Prospective, Post-market Study
Actual Study Start Date : October 2015
Actual Primary Completion Date : January 2019
Actual Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
CeraFlex occluder
The Lifetech CeraFlex™ study is a triple-arm study.
 Device: CeraFlex
The Lifetech CeraFlex™ study is a triple-arm study.


Outcome Measures
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Primary Outcome Measures :
  1. Procedural success [ Time Frame: immediate post procedure ]
    Absence of peri-procedural stroke/TIA, device embolization, cardiac or vascular perforation or death;Successful deployment of the occluder device(s).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

To participate in this study, the patient must meet all of the following inclusion criteria:

  1. Confirmed ASD, PFO or PDA and patient characteristics consistent with the corresponding IFU and sizing guidelines;
  2. The patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has signed the applicable Consent Form, approved by the appropriate Ethics Committee (EC)/IRB (where required);
  3. The patient agrees to comply with requirements of the study including the 12 months followup.

Exclusion criteria

Patients will be excluded if any of the following conditions apply:

  1. Any contra-indication mentioned in the corresponding IFU;
  2. Currently participating in another investigational drug- or device study.
Contacts and Locations
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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): NCT02621528


Locations
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France
AP Hospital Europeen G Pompidou and Hospital Necker
Paris, France
Germany
Deutsches Herzzentrum Berlin
Berlin, Germany
Herzzentrum Leipzig GmbH
Leipzig, Germany
Deutsches Herzzentrum München
Munich, Germany
Ireland
Our Lady's Children's Hospital Crumlin
Dublin, Ireland
Italy
Policlinico San Donato S.P.A.
Milan, Italy
Switzerland
Kinderspital Zürich
Zürich, Switzerland
Sponsors and Collaborators
Lifetech Scientific (Shenzhen) Co., Ltd.
Medtronic
Investigators
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Principal Investigator: Kevin Walsh, Professor Our Lady's Children's Hospital, Crumlin
More Information
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Responsible Party: Lifetech Scientific (Shenzhen) Co., Ltd.
ClinicalTrials.gov Identifier: NCT02621528    
Other Study ID Numbers: CeraFlex™ PMSS
First Posted: December 3, 2015    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020
Keywords provided by Lifetech Scientific (Shenzhen) Co., Ltd.:
CeraFlex occluder
Additional relevant MeSH terms:
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Ductus Arteriosus, Patent
Foramen Ovale, Patent
Heart Septal Defects, Atrial
Heart Defects, Congenital
Cardiovascular Abnormalities
 Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Heart Septal Defects