NL-OMON51524招募中不适用
A Prospective Open-Label Single Arm Post Market Clinical Follow-Up Trial of the FARAPULSE Pulsed Field Ablation System in Patients with Paroxysmal Atrial Fibrillation. - FARA-Freedom Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Study subjects are required to meet all the following inclusion criteria to
- •participate in this study:
- •1. Patients with PAF that meets all the following criteria:
- •a. Paroxysmal: AF that terminates spontaneously or with intervention within 7
- •days of onset.
- •b. Frequency:
- •i. Physician documentation of recurrent PAF (two or more episodes) within 6
- •months, AND
- •ii. At least one (1) documented episode by an approved recording device within
- •12 months of enrollment.
- •c. Drug Failed atrial fibrillation drug (AAD) treatment, meaning therapeutic
- •failure of at least one AAD (class I - IV) for efficacy and / or intolerance.
- •2.Patients who are >= 18 and <= 80 years of age on the day of enrollment.
- •3. Patient participation requirements:
- •a. Is willing and capable of providing Informed Consent to undergo study
- •procedures.
- •b. Is willing to participate in all examinations and follow-up visits and tests
- •associated with this clinical study.
排除标准
- •Subjects will be excluded from participating in this study if they meet any one
- •of the following exclusion criteria:
- •1. Atrial fibrillation that is any of the following:
- •a. Persistent (both early and longstanding) by diagnosis or continuous duration
- •b. Secondary to electrolyte imbalance, thyroid disease, alcohol or other
- •reversible / non-cardiac causes
- •c. Requires four (4) or more direct-current cardioversions in the preceding 12
- •2. Any of the following atrial conditions:
- •a. Left atrial anteroposterior diameter >= 5.5 cm
- •b. Any prior atrial endocardial or epicardial ablation procedure, other than
- •right sided cavotricuspid isthmus ablation or for right sided SVT
- •c. Any prior atrial surgery
- •d. Interatrial septal patch or interatrial shunt
- •e. Atrial myxoma
- •f. Current LA thrombus
- •g. LA appendage closure, device or occlusion
- •h. Any PV abnormality, stenosis or stenting (common and middle PVs are
- •admissible)
- •3. At any time, one or more of the following cardiovascular procedures,
- •implants or conditions:
- •a. Sustained ventricular tachycardia or any ventricular fibrillation
- •b. Hemodynamically significant valvular disease
- •c. Clinically significant hypertrophic cardiomyopathy
- •d. Any prosthetic heart valve, ring or repair including balloon aortic
- •valvuloplasty
- •e. Contraindication to femoral venous access
- •4. Any of the following procedures, implants or conditions:
- •a. At baseline:
- •i. Congestive heart failure with New York Heart Association (NYHA) Class III or
- •ii. Left ventricular ejection fraction (LVEF) < 35%
- •iii. Uncontrolled hypertension (SBP > 160 mmHg or DBP > 95 mmHg on two BP
- •measurements at baseline assessment)
- •iv. Implantable loop recorder or insertable cardiac monitor
- •b. Within the 3 months preceding the Consent Date:
- •i. Myocardial infarction
- •ii. Unstable angina
- •iii. Percutaneous coronary intervention
- •iv. Implantation of a pacemaker, cardioverter defibrillator or cardiac
- •resynchronization therapy device
- •v. Heart failure hospitalization
- •vi. Treatment with amiodarone
- •vii. Pericarditis or symptomatic pericardial effusion
- •viii. Gastrointestinal bleeding
- •c. Within the 6 months preceding the Consent Date:
- •i. Heart surgery
- •ii. Stroke, TIA or intracranial bleeding
- •iii. Any thromboembolic event
- •iv. Carotid stenting or endarterectomy
- •5. Diagnosed disorder of blood clotting or bleeding diathesis
- •6. Contraindication to, or unwillingness to use, systemic anticoagulation
- 另有 14 项未显示
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