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Real-Time Assessment of Cryoballoon Pulmonary Vein Isolation Using a Novel Circular Mapping Catheter (CRYO-MAP)

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ClinicalTrials.gov Identifier: NCT01448265
Recruitment Status : Completed
First Posted : October 7, 2011
Last Update Posted : July 25, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Background: Atrial fibrillation (AF) is the most frequent sustained cardiac arrhythmia, impairs quality of life and increases stroke risk and mortality. Recent clinical experience with the Arctic Front™ cryoballoon ablation catheter system (Medtronic) suggests that it can be used to isolate the pulmonary veins (PVs) safely and effectively in patients with AF, thereby eliminating the recurrence of AF.

Hypothesis: Our hypotheses are (1) that visualization of real-time pulmonary vein conduction during cryoballoon ablation of atrial fibrillation using a novel spiral circumferential mapping catheter (Achieve™) is feasible and safe, and (2) that procedure and fluoroscopy times decrease with experience.

Objective: The purpose of this study is to assess safety, feasibility, and a learning curve associated with cryoballoon catheter ablation using a novel circular mapping catheter (Achieve™, Medtronic) inserted through the lumen of the cryoballoon in patients with symptomatic paroxysmal atrial fibrillation.

The primary goal is to evaluate successful pulmonary vein isolation using the Achieve™ mapping catheter. The reduction of procedure and fluoroscopy times during the first 40 patients treated with this approach will be analyzed to evaluate a potential learning curve upon introduction of the technique.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Cryoballoon ablation. Phase 4

Detailed Description:

A total of 40 patients scheduled for a first ablation of paroxysmal AF will be included. All study subjects will undergo cryoablation using the 28 mm Arctic Front™ Cryoablation Catheter. A double transseptal approach will be followed in all study patients, allowing for use of regular guide wire and circular mapping catheter, respectively, if required.

Use of the 20 mm Achieve™ circular mapping catheter is preferred. The 15 mm AchieveTM catheter may be used at the physician's discretion. If stable balloon positions cannot be obtained, the Achieve™ catheter will be replaced by a regular guide wire and pulmonary vein isolation will be assessed by a circular mapping catheter (Lasso™; Biosense Webster) introduced through a second transseptal puncture. Cryoablations will be applied for 5 minutes each. Premature terminations will be allowed at the physician's discretion but should be avoided to allow for detection of late pulmonary vein isolation during cryoenergy application. Cryoballoon catheter manipulations (e.g., pull down maneuver) may be performed during energy application. During ablation of septal pulmonary veins, electrical phrenic nerve stimulation will be performed to exclude phrenic nerve palsy. If additional single point ablations are required to achieve electrical isolation of pulmonary veins, a linear cryocatheter (Freezor™ Max; Medtronic) will be used.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Real-Time Assessment of Cryoballoon Pulmonary Vein Isolation Using a Novel Circular Mapping Catheter
Study Start Date : September 2011
Primary Completion Date : July 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Paroxysmal atrial fibrillation. Procedure: Cryoballoon ablation.
Cryoballoon ablation using a novel circular mapping catheter.


Outcome Measures

Primary Outcome Measures :
  1. Feasibility, defined as successful pulmonary vein isolation using the novel circular mapping catheter with the cryoballoon. [ Time Frame: Participants will be followed for the duration of the ablation procedure, an expected average of 1-3 hours. ]

Secondary Outcome Measures :
  1. Time from beginning of the freeze to conduction blockade ("time to effect"). [ Time Frame: Participants will be followed for the duration of the ablation procedure, an expected average of 1-3 hours. ]
  2. Treatment-related adverse events. [ Time Frame: Participants will be followed for the duration of the ablation procedure, an expected average of 1-3 hours. ]
  3. Procedure time. [ Time Frame: Participants will be followed for the duration of the ablation procedure, an expected average of 1-3 hours. ]
  4. Overall fluoroscopy time and dose. [ Time Frame: Participants will be followed for the duration of the ablation procedure, an expected average of 1-3 hours. ]

Eligibility Criteria

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

Inclusion Criteria:

  • Documented paroxysmal atrial fibrillation
  • ≥18 and ≤75 years of age
  • Failure of one or more antiarrhythmic drugs
  • Referral for a pulmonary vein isolation catheter ablation procedure to treat atrial fibrillation

Exclusion Criteria:

  • Previous ablation of atrial fibrillation
  • Documented left atrial thrombus
  • Irregular pulmonary vein anatomy according to transesophageal echocardiography
  • Atrial fibrillation secondary to reversible cause
  • Amiodarone therapy in the previous 6 months
  • Cardiac surgery within the prior 6 months
  • Myocardial infarction within the previous 2 months
  • Ejection fraction < 40%
  • NYHA class III or IV
  • Moderate to severe valvular heart disease
  • Previous valve replacement
  • Pacemaker or implantable cardioverter defibrillator placement in the prior 3 months
  • History of stroke or TIA within the previous 12 months
  • Left atrial size ≥ 50 mm
  • Contraindication for anticoagulation medication
  • Life expectancy of less than 12 months
  • Pregnancy
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01448265


Locations
Germany
Department of Cardiology, University of Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Medtronic
Investigators
Principal Investigator: Dierk Thomas, MD Department of Cardiology, University of Heidelberg
More Information

Responsible Party: Dierk Thomas, M.D., Assistant Professor, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01448265     History of Changes
Other Study ID Numbers: CRYO-MAP
First Posted: October 7, 2011    Key Record Dates
Last Update Posted: July 25, 2013
Last Verified: July 2013

Keywords provided by Dierk Thomas, M.D., University of Heidelberg:
atrial fibrillation
catheter ablation
circular mapping catheter
cryoballoon

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