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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.

Tracking Information
First Submitted Date  ICMJE October 22, 2015
First Posted Date  ICMJE December 3, 2015
Last Update Posted Date March 13, 2020
Actual Study Start Date  ICMJE October 2015
Actual Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2015)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lifetech CeraFlex™ Post-Market Surveillance Study
Official Title  ICMJE Multi-center, Prospective, Post-market Study
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Patent Foramen Ovale
  • Atrial Septal Defect
  • Patent Ductus Arteriosus
Intervention  ICMJE Device: CeraFlex
The Lifetech CeraFlex™ study is a triple-arm study.
Study Arms  ICMJE CeraFlex occluder
The Lifetech CeraFlex™ study is a triple-arm study.
Intervention: Device: CeraFlex
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 1, 2015)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2020
Actual Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Ireland,   Italy,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02621528
Other Study ID Numbers  ICMJE CeraFlex™ PMSS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lifetech Scientific (Shenzhen) Co., Ltd.
Study Sponsor  ICMJE Lifetech Scientific (Shenzhen) Co., Ltd.
Collaborators  ICMJE Medtronic
Investigators  ICMJE
Principal Investigator: Kevin Walsh, Professor Our Lady's Children's Hospital, Crumlin
PRS Account Lifetech Scientific (Shenzhen) Co., Ltd.
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP