A Randomized Controlled Clinical Evaluation of the DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 482
- 试验地点
- 44
- 主要终点
- Safety: Freedom From a Composite of Pre-specified Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of the DIAMOND-AF study is to establish the safety and effectiveness of the DiamondTemp System for the treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation in patients.
详细描述
The DIAMOND-AF study is a prospective, single blind, 1:1 randomized controlled study being performed at multiple centers in the United States, Canada and Europe. The study will evaluate the safety and effectiveness of the DiamondTemp System used for ablation in patients with paroxysmal atrial fibrillation (AF). Subjects will be randomized for treatment with either the DiamondTemp Ablation Catheter or the TactiCath™ Quartz Contact Force Ablation Catheter manufactured by Abbott. Patients will be followed for 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •STUDY INCLUSION CRITERIA- Candidates must meet ALL the following criteria to be enrolled in the DIAMOND-AF study:
- •Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law.
- •Subjects with a history of symptomatic, paroxysmal atrial fibrillation (PAF) who have had ≥2 episodes of PAF reported within the 6 months prior to index ablation procedure with a physician note indicating recurrent, self-terminating AF.
- •At least one episode of PAF documented by electrocardiographic data within the 12 months prior to index ablation procedure.
- •Refractory to at least one Class I-IV AAD for treatment of PAF.
- •Suitable candidate for intra-cardiac mapping and ablation of arrhythmia.
- •Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months after enrollment.
- •Subject is willing and able to provide written consent.
排除标准
- •Candidates will be excluded from the DIAMOND-AF study if any of the following conditions apply within the following timeframes:
- •At time of enrollment and/or prior to procedure:
- •AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause.
- •LA diameter > 5.5 cm.
- •LVEF < 35%.
- •Currently NYHA Class III or IV or exhibits uncontrolled heart failure.
- •BMI > 40 kg/m
- •LA ablation, septal closure device or mitral valve surgical procedure at any time prior to enrollment.
- •Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation.
- •Coagulopathy, bleeding diathesis or suspected procoagulant state
- •Sepsis, active systemic infection or fever (>100.5°F / 38°C) within a week prior to the ablation procedure.
- •Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.
- •Renal failure requiring dialysis or renal compromise that in the investigator's judgement would increase risk to the subject or deem the subject inappropriate to participate in the study.
- •Known allergies or intolerance to anticoagulant and antiplatelet therapies to be used in conjunction with the study or contrast sensitivity that cannot be adequately pre-treated prior to the ablation procedure.
- •Positive pregnancy test results for female subjects of childbearing potential or breast feeding.
- •Enrollment in a concurrent clinical study that in the judgement of the investigator would impact study outcomes.
- •Acute or chronic medical condition that in the judgment of the investigator would increase risk to the subject or deem the subject inappropriate to participate in the study.
- •Life expectancy < 12 months based on medical history or the medical judgement of the investigator.
- •Within 1 month of enrollment or just prior to procedure:
- •Documented LA thrombus upon imaging.
- •Creatinine >2.5mg/dl or creatinine clearance <30mL/min.
- •Within 2 months of enrollment:
- •Regularly (uninterrupted) prescribed amiodarone.
- •Within 3 months of enrollment:
- •Significant GI bleed.
- •MI, unstable angina, cardiac surgery or coronary intervention.
- •Within 6 months of enrollment:
- •CABG procedure.
- •ICD, CRT leads or pacemaker implant procedure.
- •Documented stroke, CVA, TIA or suspected neurological event.
- •Within 12 months of enrollment:
- •An episode of AF lasting >7 days in duration.
结局指标
主要结局
Safety: Freedom From a Composite of Pre-specified Serious Adverse Events (SAEs)
时间窗: Within 30-days or 6-months after index ablation procedure
The primary safety endpoint is defined as freedom from a composite of serious adverse events (SAE) occurring within 30-days and clinically symptomatic pulmonary vein stenosis through 6-months post-index ablation procedure, as adjudicated by an independent Clinical Events Committee (CEC) for relatedness to the procedure or device. The primary safety device- or procedure-related SAE composite will be the combined rate of the following events: * Atrioesophageal fistula * Bleeding complication * Cardiac tamponade / perforation * Death * Extended hospitalization * Myocardial infarction * Pericarditis * Phrenic nerve paralysis * Pulmonary edema * Pulmonary vein stenosis * Stroke post-ablation * Thromboembolism * Transient ischemic attack (TIA) post-ablation * Vagal nerve injury * Vascular access complications
Effectiveness: Freedom From Documented Atrial Fibrillation(AF), Atrial Flutter(AFL) and Atrial Tachycardia(AT) Episodes Following the Blanking Period (3M Post-ablation) Through the End of the Effectiveness Evaluation Period (12M Post-ablation).
时间窗: 3-12M (3-12 months) after index ablation procedure
The primary effectiveness failure is defined by any of the following events: * Inability to electrically isolate all accessible targeted pulmonary veins during the ablation procedure * Documented episodes of AF, AFL or AT lasting ≥ 30 seconds in duration as evidenced by electrocardiographic data during the effectiveness evaluation period * DC cardioversion for AF, AFL or AT during the effectiveness evaluation period * A repeat ablation procedure to treat AF, AFL or AT during the effectiveness evaluation period * Use of a new or modification to existing Class I-IV anti-arrhythmic drug (AAD) regimen to treat AF, AFL or AT recurrence during the effectiveness evaluation period * Use of a non-study device for ablation of any AF targets during the index or repeat ablation procedure during the blanking period * More than one (1) repeat ablation procedure during the blanking period
次要结局
- Total Fluid Infused Through the Ablation Catheter (mL)(Index ablation procedure)
- Mean Duration of Individual Radiofrequency (RF) Ablations (Seconds)(Index ablation procedure)
- Rate of Acute Procedural Success(Index ablation procedure)
- Rate of Single Procedure Success With Freedom From Documented AF, AT and AFL at 12 Months.(Index ablation procedure through 12-months after index ablation procedure)
- Rate of Occurrence of Electrically Reconnected Pulmonary Veins (PVs)(Index ablation procedure)
- Time to Achieve Initial Pulmonary Vein Isolation (PVI) (Minutes)(Index ablation procedure)
- Total Fluoroscopy Time (Minutes)(Index ablation procedure)
- Mean Cumulative RF Time Per Procedure (Minutes)(Index ablation procedure)
- Freedom From a Composite of SAE Occurring Within 7-days(Within 7-days after the index ablation procedure)
- Freedom From Documented AF, AT and AFL Episodes in the Absence of Class I and III Anti-arrhythmic Drugs (AADs).(3-12 months after index ablation procedure)
- Rate of Single Procedure Success With Freedom From ALL Primary Effectiveness Endpoint Failure Criteria.(Index ablation procedure through 12-months after index ablation procedure)
- Total Procedure Time (Minutes)(Index ablation procedure)
- Total Treatment Device Time (Minutes)(Index ablation procedure)
- Neurological Changes Measured Using the National Institutes of Health Stroke Scale (NIHSS)(Baseline, pre-discharge after index ablation and 12-months after index ablation procedure)
- Number of Re-hospitalizations Due to Atrial Fibrillation Recurrence After Blanking Period(3-12 months after index ablation procedure)
- Accumulated Changes in Quality of Life (QOL) Using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire(Baseline, 6-months after index ablation and 12-months after index ablation)
- Total Number of RF Ablations Per Procedure(Index ablation procedure)