The RAFT-AF study will examine two options for managing atrial fibrillation in heart failure patients. The two treatment options are permitting the atrial fibrillation to continue but controlling the heart rate, or to convert the atrial fibrillation rhythm back to normal and to try to maintain the heart in sinus rhythm.
- Conditions
- The study is comparing two accepted treatment methods (rhythm control-Catheter ablation with or without anti-arrhythmic drug control of maintaining sinus rhythm versus rate controls with medical therapy &/or atrio-ventricular junction ablation and pacemaker treatment for atrial fibrillation) in patients with high burden atrial fibrillation and heart failure. This trial will enrol a total of 600 patients and patients will be randomized in a 1:1 ration to each treatment armTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2015-002516-33-SE
- Lead Sponsor
- niversity of Ottawa Heart Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 600
1.Patients with one of the following AF categories and at least one ECG documentation of AF:
a)High burden Paroxysmal defined as = 4 episodes of AF in the last 6 months, and at least one episode > 6 hours (and no other episodes that required CV or was > 7 days)
b)Persistent AF (1) defined as = 4 episodes of AF in the last 6 months, and at least one episode > 6 hours, and at least one AF episode less than 7 days but requires cardioversion. No AF episodes are > 7 days
c)Persistent AF (2) as defined by at least one episode of AF > 7 days but not > 1 year
d)Long term persistent AF defined as an AF episode, at least one year in length and no episode > 3 years
2.Optimal therapy for heart failure of at least 6 weeks (according to 2009 ACCF/AHA class 1 recommendations).
3.Heart Failure with NYHA class II or III symptoms with either impaired LV function (LVEF lessthan or equal to 45%) as determined by EF assessment within the previous 12 months or preserved LV function (LVEF > 45%) as determined by EF assessment within the previous 12 months
4.An elevated N-terminal pro brain natriuretic peptide (NT-proBNP) defined as:
A) Patient has been hospitalized for Heart Failure* in the past 9 months, has been discharged AND:
i- Is presently in Normal Sinus Rhythm and NT-pro BNP is = 400 pg/mL or
ii- Is presently in Atrial Fibrillation and NT-pro BNP is = 600 pg/mL
OR
B) Patient has had no hospitalization for Heart Failure in the past 9 months AND:
i- Has had paroxysmal Atrial Fibrillation, is presently in Normal Sinus Rhythm and NT-proBNP is = 600 pg/mL or
ii- Is presently in Atrial Fibrillation and NT-proBNP is = 900 pg/mL
*Heart Failure Admission is defined as admission to hospital > 24 hours and received treatment for Heart failure
5. Suitable candidate for catheter ablation or rate control therapy for the treatment of AF
6. Age =18
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80
1.Have an LA dimension > 55 mm as determined by an echocardiography within the previous year
2.Had an acute coronary syndrome or coronary artery bypass surgery within 12 weeks
3.Have rheumatic heart disease, severe aortic or mitral valvular heart disease using the AHA/ACC guidelines
4.Have congenital heart disease including previous ASD repair, persistent left superior vena cava
5.Had prior surgical or percutaneous AF ablation procedure or atrioventricular nodal (AVN) ablation
6.Have a medical condition likely to limit survival to < 1 year
7.Have New York Heart Association (NYHA) class IV heart failure symptoms
8.Have contraindication to systematic anticoagulation
9.Have renal failure requiring dialysis
10.AF due to reversible cause e.g. hyperthyroid state
11.Are pregnant
12.Are included in other clinical trials that will affect the objectives of this study
13.Have a history of non-compliance to medical therapy
14.Are unable or unwilling to provide informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method