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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Heidelberg University
Information provided by (Responsible Party):
Armin Luik, MD, Staedtisches Klinikum Karlsruhe
ClinicalTrials.gov Identifier:
NCT00774566
First received: October 16, 2008
Last updated: April 5, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Atrial Fibrillation
Procedure: PV-Isolation RF
Procedure: PV-Isolation Cryo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Staedtisches Klinikum Karlsruhe:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Only one ablation procedure allowed.

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


Secondary Outcome Measures:
  • Midterm clinical success rate [ Time Frame: Six months after the procedure ] [ Designated as safety issue: No ]
  • Long-term clinical success [ Time Frame: Twelve month after the procedure ] [ Designated as safety issue: No ]
  • Total radiation exposure [ Time Frame: Six month after the procedure ] [ Designated as safety issue: No ]
  • Total procedure duration [ Time Frame: Six month after the procedure ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Twelve month after the procedure ] [ Designated as safety issue: No ]
  • Changes in cardiac markers [ Time Frame: Six month after the procedure ] [ Designated as safety issue: No ]
  • Bleedings [ Time Frame: Six month after the procedure ] [ Designated as safety issue: No ]
  • Costs [ Time Frame: Six month after the procedure ] [ Designated as safety issue: No ]
  • MACE [ Time Frame: Six month after the procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 314
Study Start Date: October 2008
Estimated Study Completion Date: October 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
segmental PVI using an irrigated tip catheter
Procedure: PV-Isolation RF
Radiofrequency
Other Name: RF
Active Comparator: 2
PVI using the Cryo-Balloon
Procedure: PV-Isolation Cryo
Cryo-Balloon
Other Name: Cryo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00774566

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

Publications:
Responsible Party: Armin Luik, MD, Dr. Armin Luik, Staedtisches Klinikum Karlsruhe
ClinicalTrials.gov Identifier: NCT00774566     History of Changes
Other Study ID Numbers: SKK-001
Study First Received: October 16, 2008
Last Updated: April 5, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Staedtisches Klinikum Karlsruhe:
catheter ablation
randomized
cryo
radiofrequency
atrial fibrillation
cryo-balloon
PV-Isolation

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

ClinicalTrials.gov processed this record on October 23, 2014