Ablation as First Line Treatment in Paroxysmal Atrial Fibrillation

Not Applicable

• Conditions: Paroxysmal Atrial Fibrillation
• Interventions: Procedure: Catheter ablation using cryothermia

• Registration Number: NCT01466842
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

The purpose of this study is to determine whether catheter ablation is more effective than antiarrhythmic drugs in the early stages of paroxysmal atrial fibrillation. In all the patients a subcutaneous loop recorder will be implanted.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-11
• Study First Submitted: 2011-11-03
• Study First Submitted QC: 2011-11-07
• Last Update Submitted: 2011-11-07
• Study First Posted: 2011-11-08
• Last Update Posted: 2011-11-08
• Study Start: 2012-01
• Primary Completion: 2013-01
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Age between 18 and 65
• At least three episodes of paroxysmal atrial fibrillation documented on an electrocardiogram or event recording during the last three years
• Never taken antiarrhythmic drugs or at most a pill in the pocket approach
• Willingness, ability and commitment to participate in baseline and follow-up evaluations

Exclusion Criteria

• Paroxysmal AF for more than three years

• An episode of atrial fibrillation that lasted more than seven days within the past six months

• Persistent/permanent atrial fibrillation

• Atrial fibrillation from reversible cause (i.e. surgery, hyperthyroidism, pericarditis)

• Documented atrial flutter

• Structural heart disease of clinical significance including:

  • Cardiac surgery within six months of screening
  • Unstable symptoms of congestive heart failure (CHF) including NYHA Class III or IV CHF at screening and/or ejection fraction <30% as measured by echocardiography or catheterization
  • Unstable angina
  • Myocardial infarction within six months of screening
  • Surgically corrected atrial septal defect with a patch or closure device
  • LA size > 40mm

• Any prior ablation of the pulmonary veins

• Enrollment in any other ongoing protocol

• Untreatable allergy to contrast media

• Pregnancy

• Any contraindication to cardiac catheterization

• Prosthetic mitral heart valve

• Poor general health that, in the opinion of the Investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, etc.)

• Contraindication to coumadin or heparin

• History of pulmonary embolus or stroke within one year of screening

• Acute pulmonary edema

• Atrial clot on TEE regardless of the patient's anticoagulation medication status

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Catheter ablation	Catheter ablation using cryothermia	-

Primary Outcome Measures

Name	Time	Method
any recurrence of symptomatic AF or asymptomatic AF and atrial flutter/tachycardia in the absence of AAD therapy during a follow-up period of 6 months	6 months

Secondary Outcome Measures

Name	Time	Method
any recurrence of symptomatic AF or asymptomatic AF and atrial flutter/tachycardia in the absence of AAD therapy after the initial six months follow-up	3 years
comparison of the subjective findings of recurrence of AF by the patient through QoL and symptom questionnaires	3, 6, 12, 24 and 36 months
number of track complications, both acute (during the procedure) and chronic throughout the trial	3 years
hospitalization rate during a two and a half year follow-up following the initial six months follow-up	3 years

Trial Locations

Locations (1)

Maastricht University Medical Centre; 🇳🇱 Maastricht, Netherlands