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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Medtronic Bakken Research Center
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.

  Show Detailed Description

  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
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 11, 2014