Cryoballoon Ablation for Pulmonary Vein Isolation in Patients With Longstanding Persistent Atrial Fibrillation (the CRYO-LPAF Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Clinical success
研究概览
简要总结
Prospective and explorative clinical study. The objective is to assess the clinical efficacy of pulmonary vein isolation using the Arctic Front Advance cryoballoon in patients with longstanding persistent atrial fibrillation (AF) at one year follow up.
44 subjects will be enrolled. Patients with longstanding persistent AF, with continuous AF duration longer than one year, who have not previously undergone an AF ablation procedure, and have symptoms related to AF corresponding to at least European Heart Rhythm Association (EHRA) score 2, will be studied. Patients should have failed at least one betablocker or class I or III antiarrhythmic drug.
Excluded are those with congestive heart failure with New York Heart Association (NYHA) class 3 or more, left ventricular ejection fraction < 40%, left atrial diameter ≥ 60 mm, significant valvular disease or planned cardiac intervention within next 12 months, and conventional contraindications for AF ablation procedures.
Patients will be screened with echocardiography and response to electrical cardioversion. Following conversion to sinus rhythm, amiodarone will be initiated to maintain sinus rhythm. Pulmonary vein isolation will be performed using the Arctic Front Advance cryoballoon ablation catheter. Pulmonary vein conduction block will be assessed by a circular mapping catheter.
All patients will be subject to electroanatomical voltage mapping during sinus rhythm for demonstration of extent of atrial myocardial lesions after ablation.
Patients will be followed every third month up to one year after the ablation procedure. Arrhythmia monitoring during follow up will be performed by 7 day Holter monitoring at 6, 9 and 12 months follow up, including a 12 lead ECG. 12 months follow up for symptoms, EHRA score, and quality of life. Patients with symptomatic recurrence requiring a redo ablation procedure will be re-studied after 8-12 months while asymptomatic patients will be studied at 12 months follow up.
Primary end-Point is Clinical success based on symptoms and presence of AF. Secondary end-Points include freedom from AF without antiarrhythmic drugs at 6 and 12 months according to 7 day Holter and ECG, Rhythm, AF burden, AF profile, Quality of Life, Symptoms, Adverse Events, atrial size and function, Biomarkers, extent of scar tissue, predictive factors of freedom from AF, complications, hospitalization and Health economics.
详细描述
This is a prospective and explorative clinical study performed at one centre. Objective: The objective of this study is to assess the clinical efficacy of pulmonary vein isolation using the Arctic Front Advance cryoballoon in patients with longstanding persistent atrial fibrillation (AF) at one year follow up.
44 subjects will be enrolled. Clinical sites: Arrhythmia centre in Uppsala University Hospital, Uppsala Sweden.
Subject population: Patients with longstanding persistent AF, with continuous AF of longer duration than one year, who have not previously undergone an AF ablation procedure, and who have symptoms related to AF corresponding to at least EHRA score 2, will be studied. Atrial fibrillation should be confirmed on at least 2 consecutive ECG recordings during the past one year supporting the presence of AF for at least one year. Patients should have failed at least a betablocker or class I or III antiarrhythmic drug.
In order to exclude permanent AF patients, an electrical cardioversion with conversion to sinus rhythm maintained for at least one hour, is required.
Excluded patients are those with congestive heart failure with New York Heart Association (NYHA) class 3 or more, left ventricular ejection fraction (LVEF) < 40%, left atrial diameter (LA) ≥ 60 mm, significant valvular disease or planned cardiac intervention within the next 12 months, and conventional medical contraindications for AF ablation procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with longstanding persistent AF, with continuous AF of greater than one year, as verified by ECG or telemetry strip at least one year ago, and at inclusion but with no documentation of sinus rhythm in between.
- •Atrial fibrillation should be confirmed on at least 2 consecutive ECG supporting the presence of AF for at least one year.
- •Patients with symptoms corresponding to at least EHRA score
- •Patients, who have not previously undergone an AF ablation procedure, should have failed at least a betablocker or class I or III antiarrhythmic drug.
排除标准
- •Sinus rhythm cannot be maintained for at least 1 minute after an electrical cardioversion.
- •Congestive heart failure with NYHA class 3 or more.
- •LVEF < 35% which is not secondary to AF with inadequate rate control, according to the judgement of the investigator.
- •LA diameter ≥ 55 mm by echocardiography.
- •Prior AF ablation procedure of any kind.
- •AF secondary to a transient or correctable abnormality including electrolyte imbalance, trauma, recent surgery, infection, toxic ingestion, and uncontrolled thyroid disease as well as AF triggered by other uniform supraventricular tachycardia.
- •Contraindication to treatment with Warfarin or other anticoagulants.
- •Significant valvular disease or planned cardiac intervention.
- •Hypertrophic cardiomyopathy.
- •Recent cardiac disease states within the last 6 months; unstable angina, acute myocardial infarction, revascularisation procedures, valve disease
- •Implantable cardioverter-defibrillator (ICD), biventricular pacing device, or Dual chamber- or single chamber pacemaker patients who are dependent on ventricular pacing
- •Patients with intra-atrial thrombus, tumor, pulmonary embolism or another abnormality in whom transseptal catheterization or appropriate vascular access is precluded.
- •Renal failure requiring dialysis or abnormalities of liver function tests.
- •Participant in investigational clinical or device trial.
- •Unwilling or unable to give informed consent or inaccessible for follow-up and psychological problem that might limit compliance.
- •Active abuse of alcohol or other substance which may be causative of AF and/or might affect compliance.
结局指标
主要结局
Clinical success
时间窗: 12 months
Clinical success defined as: * Freedom from AF related symptoms, off or on previously ineffective antiarrhythmic drugs irrespective of the presence of asymptomatic AF on Holter provided AF is absent or paroxysmal in nature AF, or * Presence of AF related symptoms, off or on previously ineffective antiarrhythmic drugs, but significant symptomatic improvement to the extent that a redo procedure or a novel previously not tested antiarrhythmic drug is not desired as declared by the patient on a symptom questionnaire. Atrial fibrillation may be either absent or paroxysmal as recorded on Holter or ECG tracings after 1 or 2 procedures at 12 months.
次要结局
- Role of Pulmonary vein isolation for elimination of atrial fibrillation(12 months)
- Atrial Fibrillation burden(12 months)
- Scar tissue(12 months)
- Complete freedom from AF(6, 12 months)
- Rhythm assessed by % of subjects in sinus rhythm, paroxysmal AF and persistent AF(12 months)
- Quality of life(12 months)
- Catheter related complications(12 months)
- Symptoms Severity Questionnaire and EHRA Symptom Classification(12 months)
- Biomarkers(Baseline, 6 hours, 24 hours, 12 months)
- Health economics(12 months)
- Prediction of freedom from AF(12 months)
- Left and right atrial size and function(12 months)
研究者
Carina Blomstrom Lundqvist
Professor
Uppsala University Hospital