Real-Time Assessment of Cryoballoon Pulmonary Vein Isolation Using a Novel Circular Mapping Catheter

NCT01448265 | Completed Phase 4

• 1 other identifier: CRYO-MAP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; catheter ablation; circular mapping catheter; cryoballoon

Outcome Measures

Primary Outcomes (1)

• Feasibility, defined as successful pulmonary vein isolation using the novel circular mapping catheter with the cryoballoon.

  Participants will be followed for the duration of the ablation procedure, an expected average of 1-3 hours.

Secondary Outcomes (4)

• Time from beginning of the freeze to conduction blockade ("time to effect").

  Participants will be followed for the duration of the ablation procedure, an expected average of 1-3 hours.

• Treatment-related adverse events.

  Participants will be followed for the duration of the ablation procedure, an expected average of 1-3 hours.

• Procedure time.

  Participants will be followed for the duration of the ablation procedure, an expected average of 1-3 hours.

• Overall fluoroscopy time and dose.

  Participants will be followed for the duration of the ablation procedure, an expected average of 1-3 hours.

Study Arms (1)

Paroxysmal atrial fibrillation.

EXPERIMENTAL

Procedure: Cryoballoon ablation.

Interventions

Cryoballoon ablation. PROCEDURE

Cryoballoon ablation using a novel circular mapping catheter.

Paroxysmal atrial fibrillation.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead
• Medtronic: collaborator

Study Sites (1)

Department of Cardiology, University of Heidelberg

Heidelberg, 69120, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dierk Thomas, MD

  Department of Cardiology, University of Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 30, 2011
• First Posted: October 7, 2011
• Study Start: September 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 25, 2013

Record last verified: 2013-07

Locations

DE (1)