- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00196040
The Paradigm II Trial: PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness
December 18, 2007 updated by: Cierra
Feasibility Study of the PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness
The primary objective of this study is to demonstrate the safety and efficacy of the PFX Closure System when utilized for patent foramen ovale (PFO) in patients suffering from cryptogenic stroke (undetermined cause of stroke), transient ischemic attack (brief neurological dysfunction), migraine or decompression illness.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patent Foramen Ovale has been implicated in the etiology of paradoxical embolism, cryptogenic stroke, transient ischemic attack, and right to left gas embolism in severe decompression illness.
An association between patent foramen ovale and severe migraine headaches has also been reported.
Several implantable devices are being used for percutaneous closure of patent foramen ovale; we propose to use a non-implantable system to safely effect closure.
Study Type
Interventional
Enrollment
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Frankfurt, Germany, 60389
- Cardiovascular Center Frankfurt Sankt katharinen
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject is between 18 and 65 years old
- Documented patent foramen ovale as determined by positive micro bubble study demonstrating right to left shunt and/or anatomic detection and functional assessment by pre-operative transcranial Doppler (TCD) and peri-operative echocardiography or ultrasound.
Subjects with one or more of the following:
- history of cryptogenic stroke, transient ischemic attack (TIA) or embolism due to presumed paradoxical embolism through a PFO; or
- history of severe migraine headaches, despite attempted treatment with available migraine medications, for whom other specific causes of migraine headache, such as underlying disease or medications, have been ruled out; or
- history of severe decompression illness.
- Negative pregnancy test in women who are of child-bearing potential
- Signed Informed Consent form
Additional Inclusion Criteria for Migraine Subjects:
- Onset of migraine before age of 50 years
- History of migraine > 1 year
- Migraine frequency greater than 1 migraine per month
Exclusion Criteria:
- Presence of thrombus at the intended site of closure, in left atrial appendage, or documented evidence of venous thrombus in the vessels through which access to the PFO is gained.
- Active endocarditis, or other infections producing a bacteremia
- Presence of atrial septal defect(s) or fenestrations which allow shunting
- Presence of implanted cardiac valves, pacemakers, cardioverters/defibrillators (ICDs) or vena cava filters.
- Subjects with coagulation disorders or bleeding disorders including gastric ulcers, who are unable to take antiplatelet or anticoagulant therapy
- Subjects with an intra-cardiac mass, tumor, clots or vegetation
- Large, redundant atrial septal aneurysm that would prohibit adequate device access to the PFO or closure of the PFO, in the judgment of the investigator. A coexisting redundant atrial septal aneurysm is considered large if it prohibits the ability of the operator to adequately achieve vacuum suction necessary to achieve PFO closure.
- Presence of conduction abnormality requiring pharmacologic or electrical therapy intervention or 1st degree block
- Current enrollment in any investigational trial(s) using devices implanted in the vascular system or enrolled in any experimental drug study(ies) within three months of study entry
- Religious or other beliefs which would prevent subjects from following all physician directed instructions or prevent compliance with protocol required medications and follow-ups.
- Hemodynamic instability or shock
- History of diabetes requiring treatment with insulin
Additional Exclusion Criteria for Cryptogenic Stroke Subjects:
- History of stroke or TIA within the past 14 days
- Source of stroke other than paradoxical embolization
Additional Exclusion Criteria for Migraine Subjects:
- Seizure disorder
- Other organic central nervous system disease
- Headache as a result of traumatic head or neck injury
- Evidence of alcohol, drug or substance abuse within the previous year
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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PFO closure as measured by transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE) acutely post procedure
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Secondary Outcome Measures
Outcome Measure |
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PFO closure as measured by TEE or transthoracic echocardiography (TTE) at 30 days, 3 or 6 months and 12 months post procedure
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Adverse event (AE) rates for all subjects
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New conduction abnormality rate through final follow-up
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Measurement of migraine severity or frequency at 6 and 12 months post procedure for subjects enrolled due to diagnosis of migraine
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Horst Sievert, MD, Cardio Vasculares Centrum - Sankt Katharinen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Study Completion (Actual)
November 1, 2007
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
December 24, 2007
Last Update Submitted That Met QC Criteria
December 18, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Congenital Abnormalities
- Brain Ischemia
- Stroke
- Heart Defects, Congenital
- Cardiovascular Abnormalities
- Heart Septal Defects, Atrial
- Heart Septal Defects
- Ischemic Stroke
- Ischemic Attack, Transient
- Foramen Ovale, Patent
Other Study ID Numbers
- 2005-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Foramen Ovale, Patent
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Hangzhou Dinova EP Technology Co., LtdNot yet recruiting
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University of OregonEnrolling by invitationPatent Foramen OvaleUnited States
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Lifetech Scientific (Shenzhen) Co., Ltd.CompletedPatent Foramen OvaleIreland, Germany
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Clinical Trials on PFX Closure System
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CierraSuspendedStroke | Migraine | Transient Ischemic Attack | Decompression Illness | PFOGermany
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CierraUnknown
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CierraSuspendedPatent Foramen OvaleFrance, Germany, Belgium
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Duke UniversityKLS Martin, L.P.Completed
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Lifetech Scientific (Shenzhen) Co., Ltd.CompletedAtrial Fibrillation
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Coherex MedicalTerminatedPatients With Migraine and PFO
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Taewoong Medical Co., Ltd.TerminatedThe Patients Who Needed Hemostasis at the Puncture Site of Common Femoral Artety(CFA) Caused by Femoral Angiogram or Intervention After the Catheter RemovalKorea, Republic of
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Lifetech Scientific (Shenzhen) Co., Ltd.Recruiting
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Medtronic EndovascularCompleted