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

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ClinicalTrials.gov Identifier: NCT02294955
Recruitment Status : Unknown
Verified May 2017 by Carina Blomstrom Lundqvist, Uppsala University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 19, 2014
Last Update Posted : May 9, 2017
Sponsor:
Collaborator:
Swedish Heart Lung Foundation
Information provided by (Responsible Party):
Carina Blomstrom Lundqvist, Uppsala University Hospital

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Quality of Life Device: Catheterablation Drug: Amiodarone Drug: Sotalol Drug: Flecainide Drug: Propafenone Drug: Disopyramide Drug: Dronedarone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Catheter Ablation Compared With Pharmacological Therapy for Atrial Fibrillation - a Randomized Multicentre Study Comparing Atrial Fibrillation Ablation Strategy With Optimized Conventional Pharmacological Strategy After 12 Months Follow-up.
Study Start Date : May 2008
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Catheterablation
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
Dosage orally 600 mg once daily for 7-10 days, and 100-200 mg once daily thereafter.
Other Name: Cordarone®

Drug: Sotalol
Dosage orally 80-160 mg twice daily
Other Name: Sotalol®

Drug: Flecainide
Dosage orally 100 to 150 mg twice daily or the entire dose as slow-release formula once daily
Other Name: Tambocor®

Drug: Propafenone
Dosage orally 300 mg twice daily
Other Name: Rythmol®

Drug: Disopyramide
Dosage orally 250-375 mg twice Daily
Other Name: Norpace®

Drug: Dronedarone
Dosage orally 400 mg twice daily
Other Name: Multaq®

Active Comparator: Antiarrhythmic drug Class IC or III.
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
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.




Primary Outcome Measures :
  1. quality of life [ Time Frame: 12 months ]
    General Health related Quality of Life; Short Form (SF) 36


Secondary Outcome Measures :
  1. atrial fibrillation burden [ Time Frame: 12, 24, 36 and 48 months ]
    Total time spent in and number of episodes of atrial fibrillation, Frequency of symptomatic respectively asymptomatic episodes of AF assessed by implantable event recorder.

  2. Composite of morbidity [ Time Frame: 12, 24, 36 and 48 months ]
    Stroke, systemic embolic events, transient ischemic attack (TIA), major bleeding, cardiovascular hospitalizations, pacemaker implantation, all cause Death.

  3. Hospitalization [ Time Frame: 12, 24, 36 and 48 months ]
    Total number of hospitalization days and time to first event of hospitalization days due to cardiovascular reasons and atrial fibrillation

  4. Quality of Life [ Time Frame: 12, 24, 36 and 48 months ]
    Quality of Life by SF-36, all domains and time-points; symptom severity score (SSQ); European Heart Rhythm Association (EHRA) Symptom Classification.

  5. Health care use and economy [ Time Frame: 24 and 48 months ]
    EuroQoL (EQ) 5D, a standardised instrument for measure of health outcome, COSTs for hospitalization and outpatient visits related to and not related to AF, treatment costs, and including corrections for background variables regarding social economic status.

  6. Success of treatment [ Time Frame: 12 and 48 months ]
    Baseline predictors for symptom-based response (symptom success) and rhythm-based response.

  7. Physical capacity [ Time Frame: 12, 24, 36 and 48 months ]
    Exercise/Physical capacity and % of predicted max. as well as duration

  8. Atrial area and function [ Time Frame: 12, 24, 36 and 48 months ]
    Left atrial area and function, Right atrial area and function (from Echocardiography and corrected for body surface area.

  9. Adverse events [ Time Frame: 12, 24, 36 and 48 months ]
    Incidence, intensity and relationship of Adverse Events

  10. Recurrence of episodes of AF lasting at least one minute. [ Time Frame: 12, 24, 36 and 48 months ]
    After four weeks stabilization period, obtained from the implantable cardiac monitor and 24 hour Holter recordings and extra visits related to AF.

  11. Success/failure of treatment. [ Time Frame: 12, 24, 36, 48 months ]
    Success/failure (yes/no) with regard to symptoms and rhythm.


Other Outcome Measures:
  1. Covariate adjusted primary endpoint [ Time Frame: 12, 24, 36 and 48 months ]
    Analysis of primary endpoint using following covariates at baseline: age, sex, background variables regarding social economic status, BMI, paroxysmal or persistent AF type I or II, coronary artery disease, hypertension, diabetes, congestive heart failure, failure of an antiarrhythmic drug class I or III prior to randomization, present medication and duration of AF

  2. Recurrence of episodes of AF lasting at least one minute [ Time Frame: 12, 24, 36 and 48 months ]
    Recurrence of episodes of AF lasting at least one minute (after four weeks stabilization period), obtained from the ICM continuously and 24 hour Holter recordings and extra visits related to AF cardioversion).

  3. Baseline predictors for symptom-based response and rhythm-based response. [ Time Frame: 12, 24, 36 and 48 months ]
    Logistic multiple regression analysis to identify baseline predictors for symptom-based response (symptom success) and rhythm-based response (rhythm success if absence of AF episodes duration > 1 minute after last therapy), respectively (yes/no) by treatment Group.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. The first diagnosis of AF must have been first noted more than 6 months prior to consideration.
  3. At least one AF episode documented on 12-lead ECG or 2-channel telemetry/ Holter recording during the previous 12 months.
  4. 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
  5. 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.

Exclusion Criteria:

  1. 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).
  2. AF secondary to a transient or correctable abnormality including electrolyte imbalance, trauma, recent surgery, infection, toxic ingestion, and uncontrolled thyroid disease.
  3. Atrial fibrillation episodes triggered by another uniform supraventricular tachycardia.
  4. Untreated or uncontrolled hypertension
  5. Valvular disease requiring chronic anticoagulation or planned valve surgery within 2 years.
  6. Contraindication to treatment with Warfarin or other anticoagulants.
  7. 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.
  8. Left atrial diameter > 60 mm.
  9. Unstable angina or acute myocardial infarction within last 3 months.
  10. Cardiac revascularization procedure within last 6 months.
  11. Prior cardiac surgery or planned cardiac corrective surgery within 1 year.
  12. Prior AF ablation procedure
  13. 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.
  14. Patients with intra-atrial thrombus, tumor, or another abnormality in whom transseptal catheterization or appropriate vascular access is precluded.
  15. Renal failure requiring dialysis or abnormalities of liver function tests
  16. Participant in investigational clinical or device trial.
  17. Pregnant women.
  18. Unwilling or unable to give informed consent or inaccessible for follow-up. Specify if implantable cardiac monitor (ICM) was not accepted by the patient to be implanted.
  19. Psychological problem that might limit compliance.
  20. Active abuse of alcohol or other substance which may be causative of AF and/or might affect compliance.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02294955


Locations
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Sweden
Carina Blomström Lundqvist
Uppsala, Sweden, S-75185
Sponsors and Collaborators
Uppsala University Hospital
Swedish Heart Lung Foundation
Investigators
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Principal Investigator: Carina M Blomström Lundqvist, Professor Department of Cardiology, University Hospital in Uppsala

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Responsible Party: Carina Blomstrom Lundqvist, Professor, Senior consultant, Uppsala University Hospital
ClinicalTrials.gov Identifier: NCT02294955    
Other Study ID Numbers: 2008-001384-11
First Posted: November 19, 2014    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Keywords provided by Carina Blomstrom Lundqvist, Uppsala University Hospital:
catheter ablation
atrial fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Dronedarone
Flecainide
Sotalol
Propafenone
Disopyramide
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Voltage-Gated Sodium Channel Blockers
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Sympatholytics