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PV-Isolation With the Cryoballoon Versus RF:a Randomized Controlled Prospective Non-inferiority Trial (FreezeAF) (FreezeAF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00774566
Recruitment Status : Completed
First Posted : October 17, 2008
Last Update Posted : December 9, 2014
Heidelberg University
Information provided by (Responsible Party):
Armin Luik, MD, Staedtisches Klinikum Karlsruhe

Brief Summary:
This study is designed as a randomized, controlled, prospective, non-inferiority clinical trial, where the efficacy and safety of the cryoballoon ablation system (CE certificated) will be compared to the standard ablation technique (segmental isolation of the pulmonary veins) with radiofrequency energy. The primary study aim is to investigate whether the new cryoballoon ablation catheter system (Arctic Front CryoAblation Catheters, FlexCath Steerable Sheath, CryoCath Technologies Inc., Montreal, Canada) is at least as effective as radiofrequency (RF) segmental isolation in electrically disconnecting the pulmonary veins (PV) for the treatment of paroxysmal atrial fibrillation (AF) with respect to the absence of atrial arrhythmias without persistent complications after six and twelve months. Furthermore, the differences in terms of procedural complications such as pulmonary vein stenosis, phrenic nerve injuries, cerebrovascular accidents (CVA), pericardial tamponade, pain scores during the procedure, levels of cardiac inflammatory markers are compared between the treatment groups. The short and long-term clinical success as well as the costs of both systems will also be evaluated.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: PV-Isolation RF Procedure: PV-Isolation Cryo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 322 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of Isolating the Pulmonary Veins With the Cryoballoon Catheter Versus Radiofrequency Segmental Isolation:a Randomized Controlled Prospective Non-inferiority Trial
Study Start Date : October 2008
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
segmental PVI using an irrigated tip catheter
Procedure: PV-Isolation RF
Other Name: RF

Active Comparator: 2
PVI using the Cryo-Balloon
Procedure: PV-Isolation Cryo
Other Name: Cryo

Primary Outcome Measures :
  1. Combined endpoint out of: Absence of atrial arrhythmias and absence of persistent complications six month after the index procedure [ Time Frame: Six months after procedure ]
    Only one ablation procedure allowed.

  2. Combined endpoint out of: Absence of atrial arrhythmias and absence of persistent complications twelve months after procedure. [ Time Frame: Twelve month after the procedure ]
    Including redo procedures. Please find details for this hierarchically ordered hypotheses in statistical considerations.

Secondary Outcome Measures :
  1. Midterm clinical success rate [ Time Frame: Six months after the procedure ]
  2. Long-term clinical success [ Time Frame: Twelve month after the procedure ]
  3. Total radiation exposure [ Time Frame: Six month after the procedure ]
  4. Total procedure duration [ Time Frame: Six month after the procedure ]
  5. Quality of life [ Time Frame: Twelve month after the procedure ]
  6. Changes in cardiac markers [ Time Frame: Six month after the procedure ]
  7. Bleedings [ Time Frame: Six month after the procedure ]
  8. Costs [ Time Frame: Six month after the procedure ]
  9. MACE [ Time Frame: Six month after the procedure ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Documented paroxysmal PAF: PAF diagnosis, 2 episodes of PAF within the last 3 months, at least 1 episode of PAF must be documented.
  • Age 18-75
  • Documented effectiveness failure of at least 1 AAD including beta-blockers

Exclusion Criteria:

  • AAD usage < 3 half life periods (except beta-blocker)
  • LA size > 55 mm
  • LA thrombus
  • Previous LA ablation/surgery, structural heart disease, heart failure class III-IV
  • Hypertrophic cardiomyopathy
  • Mitral prosthesis
  • Unstable angina
  • Uncontrolled hyperthyroidism
  • Stroke or TIA within 6 months
  • Myocardial infarction within 2 months
  • Cardiac surgery within 3 months
  • Thrombocytosis, thrombocytopenia
  • Any condition contraindicating chronic anticoagulation
  • EF < 40%
  • Pregnancy
  • Life expectancy < 1 year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00774566

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Staedtisches Klinikum
Karlsruhe, Baden-Württemberg, Germany, 76133
Sponsors and Collaborators
Staedtisches Klinikum Karlsruhe
Heidelberg University
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Study Chair: Claus Schmitt, MD Staedtisches Klinikum Karlsruhe
Principal Investigator: Armin Luik, MD Staedtisches Klinikum Karlsruhe

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Armin Luik, MD, Dr. Armin Luik, Staedtisches Klinikum Karlsruhe Identifier: NCT00774566     History of Changes
Other Study ID Numbers: SKK-001
First Posted: October 17, 2008    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: December 2014

Keywords provided by Armin Luik, MD, Staedtisches Klinikum Karlsruhe:
catheter ablation
atrial fibrillation

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