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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center )
ClinicalTrials.gov Identifier:
NCT00703157
First received: June 19, 2008
Last updated: October 26, 2016
Last verified: October 2016
  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: Surgical or Catheter Ablations in Patients With Lone Atrial Fibrillation: Determination of Acute and Long Term Success Rate (SCALAF Success Trial)

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiovascular:

Primary Outcome Measures:
  • Reducton in AF burden after ablation therapy measured with REVEAL-XT implantable device. [ Time Frame: baseline and 3-6 months post-ablation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • treatment failures requiring redo or alternative therapy [ Time Frame: time of procedure ] [ Designated as safety issue: No ]
  • Duration, burden and costs of the treatment procedures [ Time Frame: time of procedure ] [ Designated as safety issue: No ]
  • reduced number, duration and severity of AF Symptoms [ Time Frame: up to 24 months of follow up ] [ Designated as safety issue: No ]
  • Symptoms associated with atrial arrhythmias [ Time Frame: up to 24 months of follow up ] [ Designated as safety issue: No ]
  • Occurences of treatment of arrhythmic episodes [ Time Frame: up to 24 months of follow up ] [ Designated as safety issue: No ]
  • Assessment of AF Burden [ Time Frame: up to 24 months of follow up ] [ Designated as safety issue: No ]
  • Decreased anti-arrhythmic and anticoagulant drug requirements [ Time Frame: up to 24 months of follow up ] [ Designated as safety issue: No ]
  • Left atrial dimension and contractility [ Time Frame: up to 24 months of follow up ] [ Designated as safety issue: No ]
  • Adverse events associated with the ablation procedure [ Time Frame: time of procedure ] [ Designated as safety issue: Yes ]
  • other clinical adverse events (TIA, CVA, haemorrhage, tamponade, MI) [ Time Frame: at 3,6,12 and 24 months of follow up ] [ Designated as safety issue: Yes ]
  • Mortality and hospitalization [ Time Frame: up to 24 months of follow up ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: November 2007
Estimated Study Completion Date: November 2016
Primary Completion Date: August 2015 (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   (Adult, Senior)
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

Locations
Netherlands
Isala Klinieken
Zwolle, Netherlands, 8011 JW
Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
Principal Investigator: Hauw Sie, MD Isala Klinieken, Zwolle
  More Information

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 26, 2016
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Individual Participant Data  
Plan to Share IPD: No
Plan Description: There is no plan or intention to share individual participant data (IPD)

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

ClinicalTrials.gov processed this record on December 08, 2016