Ablation as First Line Treatment in Paroxysmal Atrial Fibrillation

Paroxysmal Atrial Fibrillation Clinical Trial

— AFLIT-PAF  

Official title:

Ablation as First Line Treatment in Paroxysmal Atrial Fibrillation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01466842
• Other study ID #: AFLIT-PAF 1.2
• Status: Not yet recruiting
• Phase: N/A
• First received: November 3, 2011
• Last updated: November 7, 2011
• Start date: January 2012
• Est. completion date: January 2016

Study information

• Verified date: November 2011
• Source: Maastricht University Medical Center
• Contact: Laurent Pison, MD
• Phone: + 31 43 3877095
• Email: l.pison[@]mumc.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: January 2016
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Procedure:
• Catheter ablation using cryothermia
Three months before the catheter ablation procedure, a subcutaneous loop recorder will be implanted. The ablation procedure will be performed using cryothermia.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	comparison of the subjective findings of recurrence of AF by the patient through QoL and symptom questionnaires		3, 6, 12, 24 and 36 months	No
Secondary	number of track complications, both acute (during the procedure) and chronic throughout the trial		3 years	Yes
Secondary	hospitalization rate during a two and a half year follow-up following the initial six months follow-up		3 years	No