Real-Time Assessment of Cryoballoon Pulmonary Vein Isolation Using a Novel Circular Mapping Catheter (CRYO-MAP)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Cryoballoon ablation.
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, catheter ablation, circular mapping catheter, cryoballoon
Eligibility 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
Sites / Locations
- Department of Cardiology, University of Heidelberg
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Paroxysmal atrial fibrillation.
Arm Description
Outcomes
Primary Outcome Measures
Feasibility, defined as successful pulmonary vein isolation using the novel circular mapping catheter with the cryoballoon.
Secondary Outcome Measures
Time from beginning of the freeze to conduction blockade ("time to effect").
Treatment-related adverse events.
Procedure time.
Overall fluoroscopy time and dose.
Full Information
NCT ID
NCT01448265
First Posted
September 30, 2011
Last Updated
July 24, 2013
Sponsor
Heidelberg University
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT01448265
Brief Title
Real-Time Assessment of Cryoballoon Pulmonary Vein Isolation Using a Novel Circular Mapping Catheter
Acronym
CRYO-MAP
Official Title
Real-Time Assessment of Cryoballoon Pulmonary Vein Isolation Using a Novel Circular Mapping Catheter
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University
Collaborators
Medtronic
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, catheter ablation, circular mapping catheter, cryoballoon
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paroxysmal atrial fibrillation.
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Cryoballoon ablation.
Intervention Description
Cryoballoon ablation using a novel circular mapping catheter.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
Title
Treatment-related adverse events.
Time Frame
Participants will be followed for the duration of the ablation procedure, an expected average of 1-3 hours.
Title
Procedure time.
Time Frame
Participants will be followed for the duration of the ablation procedure, an expected average of 1-3 hours.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dierk Thomas, MD
Organizational Affiliation
Department of Cardiology, University of Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, University of Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Real-Time Assessment of Cryoballoon Pulmonary Vein Isolation Using a Novel Circular Mapping Catheter
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