Surgical or Catheter Ablation of Lone Atrial Fibrillation (AF) Patients (SCALAF)
Procedure: Catheter Ablation
Procedure: Surgical Ablation
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Surgical or Catheter Ablations in Patients With Lone Atrial Fibrillation: Determination of Acute and Long Term Success Rate (SCALAF Success Trial)|
- Reducton in AF burden after ablation therapy measured with REVEAL-XT implantable device. [ Time Frame: baseline and 3-6 months post-ablation ]
- treatment failures requiring redo or alternative therapy [ Time Frame: time of procedure ]
- Duration, burden and costs of the treatment procedures [ Time Frame: time of procedure ]
- reduced number, duration and severity of AF Symptoms [ Time Frame: up to 24 months of follow up ]
- Symptoms associated with atrial arrhythmias [ Time Frame: up to 24 months of follow up ]
- Occurences of treatment of arrhythmic episodes [ Time Frame: up to 24 months of follow up ]
- Assessment of AF Burden [ Time Frame: up to 24 months of follow up ]
- Decreased anti-arrhythmic and anticoagulant drug requirements [ Time Frame: up to 24 months of follow up ]
- Left atrial dimension and contractility [ Time Frame: up to 24 months of follow up ]
- Adverse events associated with the ablation procedure [ Time Frame: time of procedure ]
- other clinical adverse events (TIA, CVA, haemorrhage, tamponade, MI) [ Time Frame: at 3,6,12 and 24 months of follow up ]
- Mortality and hospitalization [ Time Frame: up to 24 months of follow up ]
|Study Start Date:||November 2007|
|Estimated Study Completion Date:||November 2016|
|Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Arm 1: Catheter Ablation
Procedure: Catheter Ablation
Patients undergoing left atrial circumferential pulmonary vein ostia ablation.
Active Comparator: 2
Arm 2: Surgical Ablation. patients undergoing left atrial circumferential pulmonary vein ostia ablation via minimal invasive surgery
Procedure: Surgical Ablation
patients undergoing left atrial circumferential pulmonary vein ostia ablation via minimal invasive surgery.
Hide Detailed Description
Title: Surgical or Catheter Ablation in patients with Lone Atrial Fibrillation: determination of acute and long term SUCCESS (SCALAF-success trial).
Background: Anti-arrhythmic drugs are used in daily practice to treat patients with paroxysmal idiopatic AF. Often the origin of the AF can be found in the muscle sleeves running up the pulmonary veins. Drug treatment is not always successful and prone to evoke negative side effects. The surgical MAZE procedure was applied in the past, but this is a time consuming, cumbersome technique, often associated with significant complications. Cardiac radio-frequency ablation offers an alternative, easy and less time consuming treatment: lesions prevent normal electrical wave front propagation and might stop the continuation of atrial fibrillation wave fronts. Ablation can be implemented by use of special catheters inserted via the groin or using the Medtronic Carbioblate® Surgical Ablation System applied via minimal invasive surgical techniques.
Purpose: Compare the effectiveness of pulmonary vein isolation achieved via catheter or via surgical ablation techniques to treat patients with paroxysmal lone AF.
Study design: A prospective, randomized multi-center observational study.
Patients: Patients suffering from paroxysmal idiopatic AF (no associated or underlying structural heart disease) complying with following inclusion criteria:
- minimally one documented AF-episode in the last 6 months;
- refractory to at least 2 class I or III anti-arrhythmic drugs;
- age > 18 year Intervention: Patients are randomized to either the surgical or the catheter ablation group and receive the indicated treatment. During the critical assessment period, the patients are weaned from anti-arrhythmic medication.
Primary endpoint: Reduction in AF occurrence measured by the AF-burden parameter in the critical period between 3 and 6 months post-ablation. AF burden is measured automatically by means of the Reveal XT, implanted at study enrolment to document the baseline characteristics.
Secondary endpoints: - Failure of therapy requiring re-interventions;
- Duration, burden and costs of ablation procedures:
- Reduction in frequency, duration and level of severity of AF symptoms;
- Symptoms associated with AF;
- Reduced necessity of anti-arrhythmic or anticoagulant medication;
- Left atrial dimensions and contractility
- Adverse events associated with the ablation therapy;
- Occurrence of other clinical adverse events (TIA, CVA, bleeds, tamponade, MI) at 3, 6, 12 and 24 months of follow up Risk assessment: Possible side effects : irregular heart rhythm, pericardial fluid, stroke, heart infarct, disturbances of the conduction system in the heart, local pain at the site of incisions, heart failure or reduced pump function of the heart.
Possible benefits: Regulation of the heart rhythm without applying MAZE procedure or opening of the thorax. Reduction or relieve from symptoms associated with AF. Partial or complete reduction of anti-arrhythmic medication. Control of anti-coagulant medication. Improved quality of life for the patients.
Hospital follow up: Follow-up visits are planned at study entrance and Reveal XT implant, assessment of baseline, application of the ablation therapy, discharge from hospital, and a 3, 6, 12 and 24 months post-ablation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00703157
|Zwolle, Netherlands, 8011 JW|
|Principal Investigator:||Hauw Sie, MD||Isala Klinieken, Zwolle|