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.
연구 개요
상세 설명
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)
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Taipei, 대만, 100
- National Taiwan University Hospital
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, 브라질, 90620-001
- Instituto de Cardiologia-FUC RS
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Stockholm, 스웨덴, S-171 76
- Karolinska University Hospital
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Alberta
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Calgary, Alberta, 캐나다, T2N 2T9
- Libin Cardiovascular Institute of Alberta, Calgary
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Edmonton, Alberta, 캐나다, T5H 3V9
- Royal Alexandra Hospital
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British Columbia
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Vancouver, British Columbia, 캐나다, V6Z 1Y6
- Vancouver General
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Victoria, British Columbia, 캐나다, V8R 4R2
- Royal Jubilee Hospital
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Nova Scotia
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Halifax, Nova Scotia, 캐나다, B3H 3A7
- Queen Elizabeth II Health Science
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Ontario
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Hamilton, Ontario, 캐나다, L8L 2X2
- Hamilton Health Sciences Centre
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Kingston, Ontario, 캐나다, K7L 2V7
- Kingston General Hospital
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Kitchener, Ontario, 캐나다, N2M 1B2
- St. Mary's General Hospital
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London, Ontario, 캐나다, N6A 5A5
- London Health Sciences Centre
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Newmarket, Ontario, 캐나다, L3Y 8C3
- Southlake Regional Health Care
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Ottawa, Ontario, 캐나다, K1Y 4W7
- University of Ottawa Heart Institute
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Toronto, Ontario, 캐나다, M4N 3M5
- Sunnybrook Health Sciences Centre
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Toronto, Ontario, 캐나다, M5G 2M9
- Toronto General Hospital, University Health Network
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Quebec
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Montreal, Quebec, 캐나다, H3A 1A1
- McGill University Health Centre
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Montreal, Quebec, 캐나다, H1T 1C8
- Institute de Cardiologie de Montréal
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Montreal, Quebec, 캐나다, H2L 4M1
- CHUM Centre hospitalier universitaire de Montréal
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Québec, Quebec, 캐나다, G1V 4G5
- Insitut universitaire de cardiologie and pneumologie de Quebec
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Sherbrooke, Quebec, 캐나다, J1H 5N4
- CHUS Centre Hospitalier Universitaire de Sherbrooke
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 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
다른 이름들:
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활성 비교기: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Composite of All-cause Mortality and Heart Failure Events
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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All-cause mortality
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Baseline to a minimum of 24 months
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Baseline to a minimum of 24 months
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Health economics
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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LV function and remodeling (LVESVi) at 1 year and 2 year follow-up
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Anthony Tang, MD FRCPC, Western University
- 수석 연구원: George Wells, PhD, Ottawa Heart Institute Research Corporation
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정된)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 231888
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