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The Paradigm II Trial: PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness

Primary Purpose

Foramen Ovale, Patent

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
PFX Closure System
Sponsored by
Cierra
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Foramen Ovale, Patent

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiovascular Center Frankfurt Sankt katharinen

Outcomes

Primary Outcome Measures

PFO closure as measured by transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE) acutely post procedure

Secondary Outcome Measures

PFO closure as measured by TEE or transthoracic echocardiography (TTE) at 30 days, 3 or 6 months and 12 months post procedure
Adverse event (AE) rates for all subjects
New conduction abnormality rate through final follow-up
Measurement of migraine severity or frequency at 6 and 12 months post procedure for subjects enrolled due to diagnosis of migraine

Full Information

First Posted
September 12, 2005
Last Updated
December 18, 2007
Sponsor
Cierra
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1. Study Identification

Unique Protocol Identification Number
NCT00196040
Brief Title
The Paradigm II Trial: PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness
Official Title
Feasibility Study of the PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cierra

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foramen Ovale, Patent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
PFX Closure System
Primary Outcome Measure Information:
Title
PFO closure as measured by transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE) acutely post procedure
Secondary Outcome Measure Information:
Title
PFO closure as measured by TEE or transthoracic echocardiography (TTE) at 30 days, 3 or 6 months and 12 months post procedure
Title
Adverse event (AE) rates for all subjects
Title
New conduction abnormality rate through final follow-up
Title
Measurement of migraine severity or frequency at 6 and 12 months post procedure for subjects enrolled due to diagnosis of migraine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Horst Sievert, MD
Organizational Affiliation
Cardio Vasculares Centrum - Sankt Katharinen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Center Frankfurt Sankt katharinen
City
Frankfurt
ZIP/Postal Code
60389
Country
Germany

12. IPD Sharing Statement

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The Paradigm II Trial: PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness

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