PFO/Migraine Nervous System Diseases Migraine
Conditions
Interventions
Double blinded study randomising migraine patients with PFOs to either PFO closure with the STARFlex® implant or a control arm who received a sham procedure, assessments of PFO were made using trans o
Sponsors
NMT Medical Inc. (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with refractory migraine Inclusion criteria: 1. The patient is greater than or equal to 18 years of age and less than or equal to 60 years of age 2. Patients must meet the definition of 'with aura' 3. Patients with a history of migraine onset prior to age 50 4. Patients must meet the definition of refractory migraine 5. Patients must have a positive contrast valsalva bubble trial by TTE, demonstrating grade 2 or 3 right to left shunting. An atrial septal aneurysm may or may not be identified. 6. Patients must be available for follow-up in accordance with the protocol 7. The patient is able to provide a signed informed consent form signed at three stages to participate. Informed consent from guardians is not acceptable. 8. Patients critical cardiac structures are not expected to come in contact with the device (e.g. AV valves and pulmonary veins). It is recommended that the device be approximately 1 mm from these structures. 9. Patients must agree not to get pregnant during the trial Post-randomisation - Device Patients Only: 10. The vascular access from the femoral vein is expected to accommodate the 11F delivery system 11. The size of the PFO (measured by indentation with a soft balloon) must demonstrate the defect to be amenable to selection of a STARFlex® Septal Repair Implant as described in the Instructions for Use
Exclusion criteria
Exclusion criteria: 1. Patients are less than 18, or greater than 60, years of age 2. Failure to meet the definition of migraine 'with aura' 3. Failure to meet the definition of refractory migraine 4. A contrast valsalva bubble study demonstrates no or trivial shunting from right to left through a PFO 5. Any cardiovascular condition, including those requiring chronic medications that would interfere with the conduct or assessment of outcome of the trial, or that would increase patient risk relative to undergoing the procedure or with the ability to deliver and deploy the STARFlex® Septal Repair System 6. Inability of the patient to personally give and sign the informed consent 7. A large, redundant atrial septal aneurysm which cannot, in the judgment of the investigator, be covered by the STARFlex® Septal Repair System without (1) causing the device to interfere with other intracardiac structures, or (2) prohibiting the ability of the operator to adequately deploy the distal/proximal arms in the left/right atrium prior to final placement on the septum. 8. Patients with an elongated waist (long tunnel), any other reason requiring Transseptal puncture for device placement 9. Other cardiac defects, whether or not repaired, including: Atrial septal defect; Ventricular septal defect; Coarctation of the aorta; Patent ductus arteriosus; or Mitral or aortic stenosis. 10. Thrombus in or occlusion of the venous lumen between the femoral vein access site (or superior access site, if used) and the right atrium 11. A previously implanted atrial septal device 12. Echocardiography evidence of an intra-atrial or ventricular thrombus 13. History of drug abuse 14. Known active endocarditis or documented bacteraemia 15. Elevated serum creatinine such that the use of contrast dye during the implant procedure would expose the patient to unnecessary risks of additional renal dysfunction 16. Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll after discontinuation of antibiotics, once asymptomatic for 4 weeks) 17. Patients who are pregnant, nursing, or planning pregnancy over the duration of the patient?s participation in the study 18. A known sensitivity to medications used in general anaesthesia 19. A known contraindication to aspirin or clopidogrel 20. Sensitivity to contrast media, which cannot be adequately pre-medicated 21. A platelet count 700,000 cells/mm3, or a WBC of <3,000 cells/mm3, or a known disorder of platelet function 22. Any patient with a known coagulopathy for which they are currently being treated medically with anticoagulants 23. Patients with any neurological disorder or disease that would interfere with proper assessment and or conduct of the trial 24. Patients unable to perform a satisfactory valsalva manoeuvre 25. Patients in whom transoesophageal echocardiography is contraindicated 26. Active peptic ulcer or upper gastrointestinal bleeding within the prior 6 months 27. Concurrent medical condition with a life expectancy of less than 12 months 28. Currently participating in an investigational drug or another device trial that has not completed the primary endpoint or that clinically interferes with the current trial endpoints. [NOTE: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.] 29. The presence of a permanent pacemaker 30. The presence of an inferior vena cav
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of migraine headache during the 90 days analysis period following the healing phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of migraine during the healing phase (the first 90 days post procedure) 2. Change in the severity of migraine attacks, based on MIDAS (Migraine Disability Assessment) and HIT-6 (Headache Impact Test) scores 3. Change in the frequency of migraine attacks other than elimination of attacks 4. Change in characteristics of migraine (with or without aura and change thereon) 5. Change in severity, frequency and character of migraine relative to effective closure rate or presence of residual leak 6. Change in quality of life based on SF36-v2 QOL survey The secondary endpoints of safety are: 7. Device success, defined as successful delivery of one or more STARFlex® device(s) to the site during the index procedure without a procedural complication, deployment of the device at the intended site, and removal of the delivery system 8. Procedural success, defined as device success without the occurrence of procedural complications prior to discharge, including device embolisation, cerebral or pulmonary embolism, cardiac perforation, and infective endocarditis The secondary endpoints of failure are: 9. Incidence of major adverse events from the STARFlex® Septal Repair Implant 10. Incidence of major vascular access complications related to the index procedure, including access site haematoma >5 cm, false aneurysm, AV fistula, retroperitoneal bleed, peripheral ischaemia/nerve injury, procedure related transfusion, and the need for vascular surgical repair or ultrasound compression 11. Incidence of adverse drug reactions to medications used in the index procedure 12. Incidence of adverse drug reactions to procedure specific medications required during the follow phase 13. Major bleeding, defined as the occurrence of intracranial, intraocular, or retroperitoneal hemorrhage or any hemorrhage requiring a blood transfusion during the index hospitalisation, or during the follow-up time period 14. Death (due to any cause) during the first 30 days following treatment 15. De | — |
Countries
United Kingdom
Outcome results
None listed