Atrial Fibrillation Clinical Trial
— SCALAFOfficial title:
Surgical or Catheter Ablations in Patients With Lone Atrial Fibrillation: Determination of Acute and Long Term Success Rate (SCALAF Success Trial)
Verified date | May 2017 |
Source | Medtronic Cardiovascular |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prospective randomized interventional trial comparing the efficacy of circumferential pulmonary vein ostia ablation using surgical versus catheter techniques in the treatment of paroxysmal atrial fibrillation. Success rate determined by REVEAL-XT (AF implantable monitoring device).
Status | Terminated |
Enrollment | 80 |
Est. completion date | November 2016 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patient has documented Paroxysmal AF as defined by the ACC/AHA/ESC guidelines - Minimal one documented AF episode in the last 6 months - Refractory to minimal two Class I or III anti-arrhythmic drug - Age > 18 years - Signed and dated the Patient Informed Consent. - Patient can tolerate anti-coagulation therapy (Warfarin/Coumadin) Exclusion Criteria: - Patient has a structural heart disease - Ejection fraction < 40 % - Echocardiographic evidence for a left atrium > 45 mm (parasternal axis) - Patients on amiodarone, or patients known to be intolerant for amiodarone - Dextrocardia, current endocarditis, systemic infection, renal failure - Patient has known cerebrovascular disease, including a history of stroke, CVA or TIA - Pregnancy at enrolment; or planned pregnancy within the follow up period - Patient has a life expectancy less than 1 year - The subject is participating in another device or drug study - The patient is unable and/or unwilling to cooperate with study procedures or required follow up visits - Echocardiographic (TTE) evidence for presence of left atrial thrombus - Previous (cardio-) thoracic surgery - Previous left atrial ablation - Patients with permanent or persistent AF |
Country | Name | City | State |
---|---|---|---|
Netherlands | Isala Klinieken | Zwolle |
Lead Sponsor | Collaborator |
---|---|
Medtronic Bakken Research Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in AF Burden After Ablation Therapy Measured With REVEAL-XT Implantable Device. | AF Burden is defined as the percentage of time during the follow-up period that a subject is in AF, as measured by the REVEAL-XT implantable device. | Baseline through 3-6 months post-ablation | |
Secondary | Treatment Failures Requiring Redo or Alternative Therapy | Time from procedure until 6 months post-ablation | ||
Secondary | Number of Subjects With Adverse Events, Associated With the Ablation Procedure | Time from procedure | ||
Secondary | Mortality and Hospitalization | Time from procedure until 24 months post-ablation | ||
Secondary | Duration, Burden and Costs of Treatment Procedures | Through 24 months post- ablation | ||
Secondary | Reduced Number, Duration and Severity of AF Symptoms | Through 24 months post-ablation | ||
Secondary | Symptoms Associated With Atrial Arrhythmias | Through 24 months post-ablation | ||
Secondary | Occurences of Treatment of Arrhythmic Episodes | Through 24 months post-ablation | ||
Secondary | Assessment of AF Burden | Through 24 months post-ablation | ||
Secondary | Reduced Anti-arrhythmic Drug Requirement | Through 24 months post-ablation | ||
Secondary | Left Atrial Dimension and Contractility | Through 24 months post-ablation |
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