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

This study has been terminated.
(Enrollments slowed down significantly, despite several attempts to re-launch.)
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center )
ClinicalTrials.gov Identifier:
NCT00703157
First received: June 19, 2008
Last updated: May 15, 2017
Last verified: May 2017
  Purpose
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).

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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 ( Medtronic Bakken Research Center ):

Primary Outcome Measures:
  • Change in AF Burden After Ablation Therapy Measured With REVEAL-XT Implantable Device. [ Time Frame: Baseline through 3-6 months post-ablation ]
    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.


Secondary Outcome Measures:
  • Treatment Failures Requiring Redo or Alternative Therapy [ Time Frame: Time from procedure until 6 months post-ablation ]
  • Number of Subjects With Adverse Events, Associated With the Ablation Procedure [ Time Frame: Time from procedure ]
  • Mortality and Hospitalization [ Time Frame: Time from procedure until 24 months post-ablation ]
  • Duration, Burden and Costs of Treatment Procedures [ Time Frame: Through 24 months post- ablation ]
  • Reduced Number, Duration and Severity of AF Symptoms [ Time Frame: Through 24 months post-ablation ]
  • Symptoms Associated With Atrial Arrhythmias [ Time Frame: Through 24 months post-ablation ]
  • Occurences of Treatment of Arrhythmic Episodes [ Time Frame: Through 24 months post-ablation ]
  • Assessment of AF Burden [ Time Frame: Through 24 months post-ablation ]
  • Reduced Anti-arrhythmic Drug Requirement [ Time Frame: Through 24 months post-ablation ]
  • Left Atrial Dimension and Contractility [ Time Frame: Through 24 months post-ablation ]

Enrollment: 80
Study Start Date: November 2007
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.
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)
Sexes Eligible for Study:   All
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
Results First Received: March 22, 2017
Last Updated: May 15, 2017
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 June 27, 2017