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Surgical or Catheter Ablation of Lone Atrial Fibrillation (AF) Patients (SCALAF)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Medtronic Bakken Research Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00703157
First received: June 19, 2008
Last updated: October 9, 2012
Last verified: October 2012
  Purpose

Prospective randomized observational 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).


Condition Intervention
Atrial Fibrillation
Procedure: Catheter Ablation
Procedure: Surgical Ablation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The SCALAF Success Trial

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • Difference in AF burden after ablation therapy measured with REVEAL-XT. [ Time Frame: Dec. 2011 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: November 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703157

Contacts
Contact: Pascal Smeets 31-43-3566671 pascal.smeets@medtronic.com
Contact: Bèr Kleijnen 31-43-3566812 bèr.kleijnen@medtronic.com

Locations
Netherlands
Isala Klinieken Recruiting
Zwolle, Netherlands, 8011 JW
Contact: Hau Sie, MD    31-38-424-5257    h.t.sie@isala.nl   
Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
Principal Investigator: Hauw Sie, MD Isala Klinieken Zwolle
  More Information

No publications provided

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00703157     History of Changes
Other Study ID Numbers: BRC-CS
Study First Received: June 19, 2008
Last Updated: October 9, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014