2023-505962-28-00招募中3 期
First-line cryoablation for early treatment of Persistent Atrial Fibrillation – a randomized study comparing early trigger isolation using the Cryoballoon versus antiarrhythmic medication
Region Oerebro Laen, University Of Pecs, Národny ustav srdcovych a cievnych chorob a.s., Gottsegen National Cardiovascular Center, Helsinki University Central Hospital9 个研究点 分布在 7 个国家目标入组 220 人开始时间: 2023年7月4日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 9
- 主要终点
- The primary endpoint is freedom from atrial tachyarrhythmia recurrence lasting ≥ 6 minutes (in the absence of AAD in ablation group) as documented by 12-lead ECG, ECG rhythm strip, Holter, or an ICM, from initiation of treatment excluding the first 3 months (blanking period) to 12 months post after initiation of allocated treatment.
研究概览
简要总结
The main focus is to evaluate the impact of early interventional management of persistent AF.
The primary goal is to evaluate if early pulmonary vein isolation performed with the Arctic Front cryoballoon as first-line therapy is superior to antiarrhythmic drugs (AAD) in preventing atrial arrhythmia recurrences.
We hypothesized that first-line PVI using the cryoballon, at an early stage of the AF disease, will result in a 25 % reduction in any atrial tachyarrhythmia recurrence at 12 months compared to the AAD group.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Non-longstanding persistent symptomatic AF with at least 2 episodes within last 24 months (both shorter than 12 months in duration), the latest episode within the previous 6 months and, one should be documented on a 12 lead ECG or Holter monitor. a) Classical persistent AF as defined by ESC guidelines, b) Persistent AF which has progressed from paroxysmal AF (patients who have been cardioverted within 7 days of onset provided a history of spontaneous conversion of episodes to sinus rhythm is lacking in near time)
- •Age 18 – 75 years
- •Candidate for rhythm control therapy; AF ablation or AAD based on symptomatic AF. As an example, BMI >35 would not according to clinical praxis be a candidate for AF ablation and thereby not suitable for participation in the study.
排除标准
- •Regular daily use of antiarrhythmic drugs of class I or III at adequate therapeutic dosages (pill-in-the-pocket permitted, beta- blockers permitted).
- •Myocardial infarction, revascularisation previous 6 months.
- •Stroke or TIA within previous 6 months.
- •Tachycardiomyopathy.
- •Dependent on VVI pacing.
- •Conventional contraindications for AF ablation including AF due to reversible causes and contraindications for both class IC and class III antiarrhythmic drugs.
- •Expected survival less than 3 years, alcohol or drug abuse.
- •Participation in another trial or absence of consent.
- •Previous AF ablation or surgery.
- •Severe heart failure (NYHA III-IV).
- •Reduced left ventricular ejection fraction (LVEF ≤40 % during sinus rhythm).
- •Hypertrophic cardiomyopathy (septal or posterior wall thickness >1.5 cm)
- •Severely enlarged LA with left atrial volume indexed to body surface area (LAVI, ml/m2) >
- •Significant valvular disease requiring treatment or valve protesis.
- •Severe COPD stage III or chronic kidney disease (eGFR< 30 umol/l).
- •Planned cardiac intervention within the next 12 months or cardiac surgery last 6 months.
结局指标
主要结局
The primary endpoint is freedom from atrial tachyarrhythmia recurrence lasting ≥ 6 minutes (in the absence of AAD in ablation group) as documented by 12-lead ECG, ECG rhythm strip, Holter, or an ICM, from initiation of treatment excluding the first 3 months (blanking period) to 12 months post after initiation of allocated treatment.
The primary endpoint is freedom from atrial tachyarrhythmia recurrence lasting ≥ 6 minutes (in the absence of AAD in ablation group) as documented by 12-lead ECG, ECG rhythm strip, Holter, or an ICM, from initiation of treatment excluding the first 3 months (blanking period) to 12 months post after initiation of allocated treatment.
次要结局
- Compare the effect of the two first-line treatment strategies with respect to total atrial arrhythmia burden (% time in AF/AT) at 12, 24, and 36 months.
- Compare the effect of the two first-line treatment strategies with respect to AF progression and reversion as measured by combination of reduced number of AF progressions or increased number of AF reversions after 3 months blanking. Progression or transition to more severe AF forms such as longstanding persistent or permanent AF and AF regression as going in the opposite direction from persistent to paroxysmal to sinus rhythm at 12, 24 and 36 months.
- Compare the effect of the two first-line treatment strategies with respect to healthcare utilization for cardiovascular reasons (number of cardioversions, ablations, AAD initiations, cardiovascular hospitalizations, emergency department visits and unplanned outpatient visits after 3 months blanking) and its relation to AF burden.
- Compare the effect of the two first-line treatment strategies with respect to health care costs at 36 months.
- Compare the effect of the two first-line treatment strategies with respect to single and multiple procedure success (freedom from ECG documented atrial tachyarrhythmia after the 1st and last ablation procedure respectively) at 12, 24, and 36 months.
- Compare the effect of the two first-line treatment strategies with respect to frequency and type of adverse events, recorded continuously and classified whether related to treatment, and whether serious.
- Compare the effect of the two first-line treatment strategies with respect to frequency of withdrawals / 'cross-overs' over time.
- Compare the effect of the two first-line treatment strategies with respect to Quality of Life measured by SF-36, EQ-5D and AFSS as change from baseline to each of months 12, 24, and 36 months. The rhythm and pulse at the time of the evaluation will be recorded.
- Compare the effect of the two first-line treatment strategies with respect to EHRA Symptom Classification, assessed as change from baseline to each of months 12, 24, and 36 months.
- Compare the effect of the two first-line treatment strategies with respect to cognitive function as measured by Trail Making Test A and B from baseline to each of months 12, 24, and 36 months. The rhythm and pulse at the time of the evaluation will be recorded.
- Compare the effect of the two first-line treatment strategies with respect to blood pressure, systolic and diastolic (mmHg) after 10 minutes rest at baseline compared to each of months 12, 24, and 36 months. The rhythm and pulse at the time of the evaluation will be recorded.
- Compare the effect of the two first-line treatment strategies with respect to covariate adjusted primary endpoint (analysis using following covariates at baseline: coronary artery disease, hypertension, LAVI).
- Compare the effect of the two first-line treatment strategies with respect to reverse atrial remodeling assessed by P wave variables from ECG (P-wave duration), biomarkers (NT pro-BNP, IL6, D-dimer), and left atrial size and function (LAVI, ejection fraction, atrial strain) by echocardiography, corrected for BSA, at 12, 24 and 36 months.
研究者
Carina Blomström-Lundqvist
Scientific
Region Oerebro Laen
研究点 (9)
Loading locations...
相似试验
招募中
4 期
Waiting on Atrial Fibrillation Intervention Therapy (WAIT) StudyNCT07275697Emma Svennberg200
已完成
不适用
STOP Persistent AFAtrial FibrillationNCT03012841Medtronic Cardiac Ablation Solutions186
招募中
不适用
Treating Atrial Fibrillation in Heart Failure With Preserved Ejection Fraction: Ablation or MedicationNCT07272902Nova Scotia Health Authority84
暂停
不适用
Persistent Atrial Fibrillation Ablation TrialAtrial FibrillationNCT01891825Neil Sulke50
进行中（未招募）
1 期
First-line catheter ablation for early treatment of Persistent (ongoing unless cardioverted) Atrial Fibrillation (AF) – a randomized study comparing isolation of pulmonary veins triggering AF using a Cryoballoon versus antiarrhythmic medication.Persistent symptomatic atrial fibrillationMedDRA version: 25.1Level: LLTClassification code 10081865Term: Cardiac catheter ablationSystem Organ Class: 100000004865EUCTR2021-006614-37-SERegion Örebro220