Catheter Ablation Compared With Pharmacological Therapy for Atrial Fibrillation (CAPTAF Trial)

NCT02294955 | Unknown DMC

• 1 other identifier: 2008-001384-11
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to compare the efficacy of 2 treatment strategies, catheter ablation of atrial fibrillation versus optimized pharmacological therapy, in patients with symptomatic atrial fibrillation. It is a randomized, prospective, controlled, open-label multicentre, parallel-group study including 116 patients. Inclusion criteria are patients aged 30-70 years with symptoms related to atrial fibrillation and who have failed or been intolerant to at least one anti-arrhythmic drug, with at least one atrial fibrillation episode documented on ECG during the previous 12 months and at least one symptomatic episode during the previous 2 months or at least 2 symptomatic episodes of persistent AF in the previous 12 months. Main exclusion criteria are patients who have tested 2 or more anti-arrhythmic drugs for rhythm control, uncontrolled hypertension, valvular disease requiring anticoagulation, planned valve surgery within 2 years, contraindication to treatment with anticoagulants, heart failure, left atrial diameter \> 60 mm, unstable angina or acute myocardial infarction within the last 3 months, cardiac revascularization procedure within the last 6 months, prior cardiac surgery or planned cardiac corrective surgery within 1 year, prior AF ablation procedure. The primary endpoint is general health-related quality of life at 12 months follow-up. The main secondary endpoints are morbidity and mortality as composite outcome, cardiovascular hospitalization, symptoms, heart failure, left atrial and ventricular function and diameters, exercise capacity, health care economics, rhythm, atrial fibrillation burden, successful versus failed treatment, safety and "cross-overs" over time. Patients will receive a cardiac monitor, implanted subcutaneously, which will monitor the heart rhythm during a two month "Run-in" period, for the definition of the basic atrial fibrillation burden. Patients will be randomly assigned to an antiarrhythmic drug (for rhythm or rate control) or to left atrial catheter ablation. Evaluation of outcome is at 12, 24, 36 and 48 months of follow-up, while health economy will be evaluated at 24 and 48 months of follow-up.. In case of documented disease progression or unacceptable toxicity, subjects will be switched to the alternative regimen. The main statistical analysis of the primary endpoint will be based on the intention-to-treat population. The trial duration is 48 months.

Conditions

Atrial Fibrillation; Quality of Life

Keywords

catheter ablation; atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• quality of life

  General Health related Quality of Life; Short Form (SF) 36

  12 months

Secondary Outcomes (11)

• atrial fibrillation burden

  12, 24, 36 and 48 months

• Composite of morbidity

  12, 24, 36 and 48 months

• Hospitalization

  12, 24, 36 and 48 months

• Quality of Life

  12, 24, 36 and 48 months

• Health care use and economy

  24 and 48 months

Other Outcomes (3)

• Covariate adjusted primary endpoint

  12, 24, 36 and 48 months

• Recurrence of episodes of AF lasting at least one minute

  12, 24, 36 and 48 months

• Baseline predictors for symptom-based response and rhythm-based response.

  12, 24, 36 and 48 months

Study Arms (2)

Catheterablation

ACTIVE COMPARATOR

Pulmonary vein isolation with Cryo-energy using a Arctic Front™ Cardiac CryoAblation Catheter or an irrigated radiofrequency ablation catheter, with an optional roof line.

Drug: Amiodarone; Drug: Sotalol; Drug: Flecainide; Drug: Propafenone; Drug: Disopyramide; Drug: Dronedarone

Antiarrhythmic drug Class IC or III.

ACTIVE COMPARATOR

Serial testing of oral antiarrhythmic drugs; amiodarone 600 mg once daily 7-10 days, then 100-200 mg once daily; sotalol: 80-160 mg twice daily; flecainide 100 to 150 mg twice daily or entire dose as slow-release formula once daily; propafenone 300 mg twice daily; disopyramide 250-375mg twice daily, or dronedarone 400 mg twice Daily.

Device: Catheterablation

Interventions

Catheterablation DEVICE

Pulmonary vein isolation using either Arctic Front™ Cardiac CryoAblation or irrigated radiofrequency catheter ablation. A linear lesion, a left atrial roof line, is optional for patients with AF recurrence after a first procedure or primarily for patients with persistent AF.

Antiarrhythmic drug Class IC or III.

Amiodarone DRUG

Dosage orally 600 mg once daily for 7-10 days, and 100-200 mg once daily thereafter.

Also known as: Cordarone®

Catheterablation

Sotalol DRUG

Dosage orally 80-160 mg twice daily

Also known as: Sotalol®

Catheterablation

Flecainide DRUG

Dosage orally 100 to 150 mg twice daily or the entire dose as slow-release formula once daily

Also known as: Tambocor®

Catheterablation

Propafenone DRUG

Dosage orally 300 mg twice daily

Also known as: Rythmol®

Catheterablation

Disopyramide DRUG

Dosage orally 250-375 mg twice Daily

Also known as: Norpace®

Catheterablation

Dronedarone DRUG

Dosage orally 400 mg twice daily

Also known as: Multaq®

Catheterablation

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with symptoms related to atrial fibrillation (AF), who have failed or been intolerant to at least one drug used for either rate or rhythm control (Vaughan Williams class I, II, or III anti-arrhythmic drug) thus excluding digitalis and Calcium channel inhibitors.
• The first diagnosis of AF must have been first noted more than 6 months prior to consideration.
• At least one AF episode documented on 12-lead ECG or 2-channel telemetry/ Holter recording during the previous 12 months.
• Paroxysmal AF (AF is self-terminating within 7 days of recognized onset) with occurrence of at least one symptomatic episodes (patient history) in the previous 2 months that merits non-pharmacological intervention (see classification), or
• Persistent AF (AF is not self-terminating within 7 days or is terminated electrically or pharmacologically) with occurrence of at least 2 symptomatic episodes of AF in the previous 12 months, necessitating pharmacological or electrical cardioversions (CV), on or off antiarrhythmic drugs that merits non-pharmacological intervention. Upon cardioversion, it must be documented that sinus rhythm can be maintained for at least 1 hour, to distinguish from permanent AF.

You may not qualify if:

• Patients who have tested 2 or more anti-arrhythmic drugs for rhythm control at highest tolerable dosages (Vaughan Williams class I or III anti-arrhythmic drug; flecainide, propafenone, disopyramide, sotalol or amiodarone).
• AF secondary to a transient or correctable abnormality including electrolyte imbalance, trauma, recent surgery, infection, toxic ingestion, and uncontrolled thyroid disease.
• Atrial fibrillation episodes triggered by another uniform supraventricular tachycardia.
• Untreated or uncontrolled hypertension
• Valvular disease requiring chronic anticoagulation or planned valve surgery within 2 years.
• Contraindication to treatment with Warfarin or other anticoagulants.
• Heart failure with New York Heart Association (NYHA ) class III or IV or left ventricular ejection fraction (LVEF) \< 35 %, which is not secondary to AF with inadequate rate control, according to the judgement of the investigator.
• Left atrial diameter \> 60 mm.
• Unstable angina or acute myocardial infarction within last 3 months.
• Cardiac revascularization procedure within last 6 months.
• Prior cardiac surgery or planned cardiac corrective surgery within 1 year.
• Prior AF ablation procedure
• Implantable cardioverter-defibrillator, biventricular pacing device, Dual chamber- and single chamber -pacemaker if needed for ventricular pacing, as well as Atrioventricular (AV) block II-III and sustained ventricular tachyarrhythmias.
• Patients with intra-atrial thrombus, tumor, or another abnormality in whom transseptal catheterization or appropriate vascular access is precluded.
• Renal failure requiring dialysis or abnormalities of liver function tests

Sponsors & Collaborators

• Uppsala University Hospital: lead
• Swedish Heart Lung Foundation: collaborator

Study Sites (1)

Carina Blomström Lundqvist

Uppsala, S-75185, Sweden

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Amiodarone; Sotalol; Flecainide; Propafenone; Disopyramide; Dronedarone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Propiophenones; Ketones; Pyridines

Study Officials

• Carina M Blomström Lundqvist, Professor

  Department of Cardiology, University Hospital in Uppsala

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Senior consultant

Study Record Dates

• First Submitted: November 12, 2014
• First Posted: November 19, 2014
• Study Start: May 1, 2008
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

SE (1)