FLAT Study: First Line Ablation Therapy for Treatment of Paroxysmal Atrial Fibrillation (RAAFT)

NCT00137540 | Completed Phase 3

• 1 other identifier: FLAT
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this multicenter randomized study is to establish the effectiveness of treatment for paroxysmal atrial fibrillation (AF), in patients not previously treated with anti-arrhythmic drugs, by encircling the pulmonary veins with radiofrequency (RF) ablation, using the NaviStar® ThermoCool® catheter and the CARTO™ EP Navigation System. Effectiveness will be determined by comparing chronic success of ablation therapy versus anti-arrhythmic drug treatment, defined as patients with an absence of atrial tachycardias during 24 months of follow-up as determined by 7-days Holter and transtelephonic monitoring, and by 12-lead electrocardiogram (ECG) recordings.

Conditions

Atrial Fibrillation

Keywords

First line ablation therapy

Outcome Measures

Primary Outcomes (1)

• long-term success

  19 months

Secondary Outcomes (4)

• AF-burden

  19 months

• health-economic costs

  24 months

• serious adverse events

  19 months

• Quality of Life scores

  19 months

Interventions

RF ablation DEVICE

anti-arrhythmic drug therapy DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent obtained
• Two or more documented symptomatic paroxysmal atrial fibrillation episodes during the last 6 months. Episodes should last longer than 30 seconds.
• Patients should not be on anti-arrhythmic medication therapy (Class I, III or IV) for AF (other than for cardioversion) or are currently on antiarrhythmic drug (AAD) therapy for any other arrhythmia

You may not qualify if:

• Patients who had a previous ablation for atrial fibrillation
• Patients who had presence of severe valvular disease, myocardial infarction and/ or cardiomyopathy
• Patients with a left atrial size more than 50 mm
• Patients who had more than 2 cardioversions
• Patients who have a history of AF for less than 3 months or more than one year
• Patients with solely asymptomatic AF
• Patients who have AF episodes triggered by another uniform arrhythmia
• Patients who actively abuse alcohol or other drugs, which may be causative of AF
• Patients with a tumor, or another abnormality which precludes catheter introduction
• Patients with a revascularization or other cardiac surgery within 6 months before study treatment
• Patients in whom appropriate vascular access is precluded
• Patients with a contraindication to treatment with warfarin or other bleeding diathesis participants in another investigational clinical or device trial
• Patients who are inaccessible for follow-up psychological problem that might limit compliance
• Patients who cannot or will not fulfill the follow-up or protocol requirements
• Pregnant women

Sponsors & Collaborators

• Biosense Webster EMEA: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• F. Gaita, Prof.

  Ospedale Civile, Asti, Italy

  PRINCIPAL INVESTIGATOR

• P. Della Bella, MD

  Centro Cardiologico Monzino, Milan, Italy

  PRINCIPAL INVESTIGATOR

• M. Fiala, MD

  Nemocnice Podlesi, Trinec, Czech Republic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2005
• First Posted: August 30, 2005
• Study Start: September 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: July 1, 2008
• Last Updated: February 3, 2025

Record last verified: 2025-01