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

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Dierk Thomas, M.D., University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01448265
First received: September 30, 2011
Last updated: July 24, 2013
Last verified: July 2013

September 30, 2011
July 24, 2013
September 2011
July 2013   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01448265 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: No ]
  • Treatment-related adverse events. [ Time Frame: Participants will be followed for the duration of the ablation procedure, an expected average of 1-3 hours. ] [ Designated as safety issue: Yes ]
  • Procedure time. [ Time Frame: Participants will be followed for the duration of the ablation procedure, an expected average of 1-3 hours. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Real-Time Assessment of Cryoballoon Pulmonary Vein Isolation Using a Novel Circular Mapping Catheter
Real-Time Assessment of Cryoballoon Pulmonary Vein Isolation Using a Novel Circular Mapping Catheter

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.

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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrial Fibrillation
Procedure: Cryoballoon ablation.
Cryoballoon ablation using a novel circular mapping catheter.
Experimental: Paroxysmal atrial fibrillation.
Intervention: Procedure: Cryoballoon ablation.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01448265
CRYO-MAP
No
Dierk Thomas, M.D., University of Heidelberg
Heidelberg University
Medtronic
Principal Investigator: Dierk Thomas, MD Department of Cardiology, University of Heidelberg
Heidelberg University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP