Prospective Randomized Multi-center Controlled Clinical Investigation Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion.
|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: NCT05069558|
Recruitment Status : Not yet recruiting
First Posted : October 6, 2021
Last Update Posted : October 6, 2021
|Condition or disease||Intervention/treatment||Phase|
|Stroke Patent Foramen Ovale||Device: Investigational PFO Closure Device Device: Standard of Care PFO Closure Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Prospective Randomized Multi-center Controlled Clinical Investigation Comparing Patent Foramen Ovale (PFO) Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion.|
|Estimated Study Start Date :||October 26, 2021|
|Estimated Primary Completion Date :||October 26, 2025|
|Estimated Study Completion Date :||October 26, 2026|
Experimental: Investigational PFO Closure Device
PFO closure with the study Occlutech Flex II PFO device.
Device: Investigational PFO Closure Device
Occlutech Flex II PFO Closure Device
Active Comparator: Standard of Care PFO Closure Device
PFO closure with either of the standard of care PFO occlusion devices; Amplatzer PFO Occluder or the Gore Cardioform PFO Occluder.
Device: Standard of Care PFO Closure Device
Amplatzer PFO Occluder and Gore Cardioform PFO Occluder
- Effective Closure Rate of PFO [ Time Frame: Twelve Months ]
- Non-Fatal Recurrent Stroke [ Time Frame: Enrollment to 12 Months ]
- Safety: Device and Procedure Related Serious Adverse Events [ Time Frame: Enrollment to Twelve Months, Annually thereafter. ]
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): NCT05069558
|Contact: Susan G. Wiskowfirstname.lastname@example.org|
|Contact: Ken Lockemail@example.com|