Ablation as First Line Treatment in Paroxysmal Atrial Fibrillation (AFLIT-PAF)

Maastricht University Medical Centre (MUMC)

Status: Unknown

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Procedure: Catheter ablation using cryothermia

Study type: Interventional

Funder types: Other

Identifiers

NCT01466842

AFLIT-PAF 1.2

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Catheter ablation

Other group

Treatment:

Procedure: Catheter ablation using cryothermia

Antiarrhythmic drugs

No Intervention group

Description:

Three months before starting antiarrhythmic drugs, a subcutaneous loop recorder will be implanted.