Rhythm Control - Catheter Ablation With or Without Anti-arrhythmic Drug Control of Maintaining Sinus Rhythm Versus Rate Control With Medical Therapy and/or Atrio-ventricular Junction Ablation and Pacemaker Treatment for Atrial Fibrillation (RAFT-AF)
A Randomized Ablation-based Atrial Fibrillation Rhythm Control Versus Rate Control Trial in Patients With Heart Failure and High Burden Atrial Fibrillation
Atrial fibrillation and heart failure are two common heart conditions that are associated with an increase in death and suffering. When both of these two conditions occur in a patient the patient's prognosis is poor. These patients have poor life quality and are frequently admitted to the hospital. The treatment of atrial fibrillation in heart failure patients is extremely challenging. Two options for managing the atrial fibrillation are permitting the atrial fibrillation to continue but controlling the heart rate, or to convert the atrial fibrillation rhythm back to normal and try to maintain the heart in sinus rhythm. Until now, the method to keep the patient in normal sinus rhythm is with antiarrhythmic drugs. Studies using antiarrhythmic drugs to control the rhythm failed to show any survival benefit when compared with permitting the patient to be in atrial fibrillation. In the last few years, new development in techniques and technologies now enable catheter ablation (cauterization of tissue in the heart with a catheter) to be a successful treatment in abolishing atrial fibrillation and that this approach is better than antiarrhythmic drug to control the rhythm. However, there has not been any long-term study to determine whether catheter ablation to abolish atrial fibrillation in heart failure patients would reduce mortality or admissions for heart failure.
This study is to compare the effect of catheter ablation-based atrial fibrillation rhythm control to rate control in patients with heart failure and high burden atrial fibrillation on the composite endpoint of all-cause mortality and heart failure events defined as an admission to a healthcare facility for > 24 hours or clinically significant worsening heart failure leading to an intervention (defined as treatment in an emergency department, a same-day access clinic, or an infusion centre) or unscheduled visits to a healthcare provider for administration of an intravenous diuretic and an increase in chronic heart failure therapy. This study may have a dramatic impact on the way the investigators manage these patients with atrial fibrillation and heart failure and may improve the outlook and well being of these patients.
調査の概要
詳細な説明
Substudy_ In a subset of patients, following informed consent, additional data collection will include annual NT-proBNP/BNP measurements, Echocardiogram baseline and annually and 14 Day ECG Continuous Monitoring at six month intervals.
Updated June 2024:
Additional analysis will be completed using the winratio analysis for the hierarchical primary outcome of:
- All-cause mortality (time to event)
- Heart Failure Events (number of events per year) defined as an admission to a healthcare facility for > 24 hours or clinically significant worsening heart failure leading to an intervention (defined as treatment in an emergency department, a same-day access clinic, or an infusion centre) or unscheduled visits to a healthcare provider for administration of an intravenous diuretic as accepted by FDA, and an increase in chronic heart failure therapy
- Minnesota Living with Heart Failure Questionnaire (change from baseline to 12-month)
- Six Minute Hall Walk Test (change from baseline to 12-month)
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Alberta
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Calgary、Alberta、カナダ、T2N 2T9
- Libin Cardiovascular Institute of Alberta, Calgary
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Edmonton、Alberta、カナダ、T5H 3V9
- Royal Alexandra Hospital
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British Columbia
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Vancouver、British Columbia、カナダ、V6Z 1Y6
- Vancouver General
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Victoria、British Columbia、カナダ、V8R 4R2
- Royal Jubilee Hospital
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Nova Scotia
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Halifax、Nova Scotia、カナダ、B3H 3A7
- Queen Elizabeth II Health Science
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Ontario
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Hamilton、Ontario、カナダ、L8L 2X2
- Hamilton Health Sciences Centre
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Kingston、Ontario、カナダ、K7L 2V7
- Kingston General Hospital
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Kitchener、Ontario、カナダ、N2M 1B2
- St. Mary's General Hospital
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London、Ontario、カナダ、N6A 5A5
- London Health Sciences Centre
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Newmarket、Ontario、カナダ、L3Y 8C3
- Southlake Regional Health Care
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Ottawa、Ontario、カナダ、K1Y 4W7
- University of Ottawa Heart Institute
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Toronto、Ontario、カナダ、M4N 3M5
- Sunnybrook Health Sciences Centre
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Toronto、Ontario、カナダ、M5G 2M9
- Toronto General Hospital, University Health Network
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Quebec
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Montreal、Quebec、カナダ、H3A 1A1
- McGill University Health Centre
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Montreal、Quebec、カナダ、H1T 1C8
- Institute de Cardiologie de Montréal
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Montreal、Quebec、カナダ、H2L 4M1
- CHUM Centre hospitalier universitaire de Montréal
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Québec、Quebec、カナダ、G1V 4G5
- Insitut universitaire de cardiologie and pneumologie de Quebec
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Sherbrooke、Quebec、カナダ、J1H 5N4
- CHUS Centre Hospitalier Universitaire de Sherbrooke
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Stockholm、スウェーデン、S-171 76
- Karolinska University Hospital
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Rio Grande do Sul
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Porto Alegre、Rio Grande do Sul、ブラジル、90620-001
- Instituto de Cardiologia-FUC RS
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Taipei、台湾、100
- National Taiwan University Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
説明
Inclusion Criteria:
Patients with one of the following AF categories and at least one ECG documentation of AF
- High burden Paroxysmal defined as ≥ 4 episodes of AF in the last 6 months, and at least one episode > 6 hours (and no episode requiring cardioversion and no episode > 7 days)
- 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
- Persistent AF (2) as defined by at least one episode of AF > 7 days but not > 1 year
- Long term persistent AF defined as an AF episode, at least one year in length and no episodes > 3 years
- Optimal therapy for heart failure of at least 6 weeks (according to 2009 ACCF/AHA class 1 recommendations).
- HF with NYHA class II or III symptoms with either impaired LV function (LVEF ≤ 45%) as determined by EF assessment within the previous 12 months or preserved LV function (LVEF > 45%) determined by by EF assessment within the previous 12 months
NT-pro BNP measures:
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
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
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
- Suitable candidate for catheter ablation or rate control therapy for the treatment of AF
- Age ≥18
Exclusion Criteria:
- Have an LA dimension > 55 mm as determined by an echocardiography within the previous year
- Had an acute coronary syndrome or coronary artery bypass surgery within 12 weeks
- Have rheumatic heart disease, severe aortic or mitral valvular heart disease using the AHA/ACC guidelines
- Have congenital heart disease including previous ASD repair, persistent left superior vena cava
- Had prior surgical or percutaneous AF ablation procedure or atrioventricular nodal (AVN) ablation
- Have a medical condition likely to limit survival to < 1 year
- Have New York Heart Association (NYHA) class IV heart failure symptoms
- Have contraindication to systematic anticoagulation
- Have renal failure requiring dialysis
- AF due to reversible cause e.g. hyperthyroid state
- Are pregnant
- Are included in other clinical trials that will affect the objectives of this study
- Have a history of non-compliance to medical therapy
- Are unable or unwilling to provide informed consent
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Rhythm Control
Patients randomized to catheter ablation-based AF rhythm control group will receive optimal Heart Failure therapy and one or more aggressive catheter ablation, which include PV antral ablation and LA substrate ablation with or without adjunctive antiarrhythmic drug.
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Patients randomized to catheter ablation-based AF rhythm control group will receive optimal HF therapy and one or more aggressive catheter ablation, which include PV antral ablation and LA substrate ablation with or without adjunctive antiarrhythmic drug
他の名前：
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アクティブコンパレータ：Rate Control
Patients in the rate control group will receive optimal Heart Failure therapy and rate control measures to achieve a resting HR < 80 bpm and 6-minute walk HR < 110 bpm.
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Patients in the rate control group will receive optimal HF therapy and rate control measures to achieve a resting HR < 80 bpm and 6-minute walk HR < 110 bpm.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Composite of All-cause Mortality and Heart Failure Events
時間枠：Baseline to study completion, an average of 24 months
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Heart failure event defined as an admission to a healthcare facility for > 24 hours or clinically significant worsening heart failure leading to an intervention (defined as treatment in an emergency department, a same-day access clinic, or an infusion centre) or unscheduled visits to a healthcare provider for administration of an intravenous diuretic as accepted by FDA and an increase in chronic heart failure therapy
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Baseline to study completion, an average of 24 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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All-cause mortality
時間枠：Baseline to a minimum of 24 months
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All-cause mortality
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Baseline to a minimum of 24 months
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Heart Failure events
時間枠：Baseline to a minimum of 24 months
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Heart failure event defined as an admission to a healthcare facility for > 24 hours or clinically significant worsening heart failure leading to an intervention (defined as treatment in an emergency department, a same-day access clinic, or an infusion centre) or unscheduled visits to a healthcare provider for administration of an intravenous diuretic as accepted by FDA and an increase in chronic heart failure therapy
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Baseline to a minimum of 24 months
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Health related QoL
時間枠：Baseline to a minimum of 24 months
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Minnesota Living with Heart Failure.
Scoring: The higher the score, the worse the HRQL
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Baseline to a minimum of 24 months
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Health related QoL
時間枠：Baseline to a minimum of 24 months
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EuroQol- 5 Dimension.
Scoring 0 = worst to 100 = best
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Baseline to a minimum of 24 months
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Health related QoL
時間枠：Baseline to a minimum of 24 months
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Atrial Fibrillation Effect on Quality-of-life.
Scoring 0 = worst to 100 = best
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Baseline to a minimum of 24 months
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Exercise capacity
時間枠：Baseline to a minimum of 24 months
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as determined by 6 Minute Hall walk distance
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Baseline to a minimum of 24 months
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NT-proBNP/BNP at 1 year and at 2 year follow-up
時間枠：Baseline to a minimum of 24 months
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NT-proBNP/BNP
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Baseline to a minimum of 24 months
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All-cause mortality and heart failure events in patients with HF, impaired (LVEF≤45%) LV function and high burden AF
時間枠：Baseline to a minimum of 24 months
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Baseline to a minimum of 24 months
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All-cause mortality and heart failure events in patients with HF, preserved (LVEF > 45%) LV function and high burden AF
時間枠：Baseline to a minimum of 24 months
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Baseline to a minimum of 24 months
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Health economics
時間枠：Baseline to a minimum of 24 months
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Cost economics
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Baseline to a minimum of 24 months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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LV function and remodeling (LVESVi) at 1 year and 2 year follow-up
時間枠：Baseline to a minimum of 24 months
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Echocardiogram measure LVESVi
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Baseline to a minimum of 24 months
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AF Burden at 1 year and 2 year follow-up
時間枠：Baseline to a minimum of 24 months
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14 Day Continuous ECG monitoring
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Baseline to a minimum of 24 months
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Total number of heart failure events
時間枠：Baseline to a minimum of 24 months
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Heart failure event defined as an admission to a healthcare facility for > 24 hours or clinically significant worsening heart failure leading to an intervention (defined as treatment in an emergency department, a same-day access clinic, or an infusion centre) or unscheduled visits to a healthcare provider for administration of an intravenous diuretic as accepted by FDA and an increase in chronic heart failure therapy
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Baseline to a minimum of 24 months
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Total number of Cardiovascular hospitalizations
時間枠：Baseline to a minimum of 24 months
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Cardiovascular hospitalizations
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Baseline to a minimum of 24 months
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Safety (Adverse Events)
時間枠：Baseline to a minimum of 24 months
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Thromboembolic events, symptomatic Pulmonary vein stenosis, atrio-esophageal fistula, pericardial effusion requiring pericardiocentesis, major bleeding requiring blood transfusion, amiodarone induced thyroid, pulmonary and other toxicity
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Baseline to a minimum of 24 months
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協力者と研究者
捜査官
- 主任研究者：Anthony Tang, MD FRCPC、Western University
- 主任研究者：George Wells, PhD、Ottawa Heart Institute Research Corporation
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (推定)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 231888
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。