Ablation as First Line Treatment in Paroxysmal Atrial Fibrillation

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01466842
• Date of registration: 03/11/2011
• Primary sponsor: Maastricht University Medical Center
• Public title: Ablation as First Line Treatment in Paroxysmal Atrial Fibrillation AFLIT-PAF
• Scientific title: Ablation as First Line Treatment in Paroxysmal Atrial Fibrillation
• Date of first enrolment: January 2012
• Target sample size: 160
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT01466842
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Netherlands

Contacts

• Name: Suzanne Philippens

• Name: Laurent Pison, MD

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Paroxysmal Atrial Fibrillation

Intervention(s)

Procedure: Catheter ablation using cryothermia

Primary Outcome(s)

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 [Time Frame: 6 months]

Secondary Outcome(s)

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 [Time Frame: 3 years]

comparison of the subjective findings of recurrence of AF by the patient through QoL and symptom questionnaires [Time Frame: 3, 6, 12, 24 and 36 months]

hospitalization rate during a two and a half year follow-up following the initial six months follow-up [Time Frame: 3 years]

number of track complications, both acute (during the procedure) and chronic throughout the trial [Time Frame: 3 years]

Secondary ID(s)

AFLIT-PAF 1.2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors