EUCTR2012-002338-35-ES进行中（未招募）1 期
ATrial FibrillaTion ProgrESsion Trial (ATTEST Trial) - ATTEST
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 255
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patients with recurrent AF for 2 years, with > or = to 6 episodes over the last 6 months;
- •- HATCH Score of at least > or = to 1 and < or = to 4.
- •- Eligible for catheter ablation and for anti-arrhythmic or rate control medications, after having failed no more than 2 prescribed drugs (either anti-arrhythmic or rate control drug).
- •- Age 60 years or older.
- •- LA diameter < or = 55mm by TTE.
- •- LV ejection fraction > or = to 50% when in sinus rhythm or LV ejection fraction > or = to 35% when in AF.
- •- Signed Patient Informed Consent Form.
- •- Able and willing to comply with protocol requirements, including all baseline and followup testing
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 280
排除标准
- •- Patients awaiting cardiac transplantation or other cardiac surgery.
- •- Acute illness (ongoing) or active systemic infection or sepsis.
- •- Reversible causes of AF, including thyroid disorders, acute alcohol intoxication, recent major surgical procedures or trauma.
- •- Recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3 months.
- •- Heart failure decompensation.
- •- Previous stroke.
- •- Pulmonary embolism or recent atrial embolism/thrombosis.
- •- Hypertrophic obstructive cardiomyopathy.
- •- Class IV angina or Class IV CHF (including past or planned heart transplantation).
- •- Mandated anti-arrhythmic drug therapy for disease conditions other than AF.
- •- Heritable arrhythmias or increased risk for torsade de pointes with class I or III Drugs.
- •- Prior LA catheter ablation with the intention of treating AF; prior surgical interventions for AF such as the MAZE procedure.
- •- Prior AV nodal ablation.
- •- Patients presenting contra-indications for the study catheter(s), as indicated in the respective Instructions For Use.
- •- Contraindication to warfarin, other anticoagulation therapy, or all anti-platelet medications.
- •- Medical conditions limiting expected survival to < 3 years.
- •- Concurrent participation in any other clinical study.
- •- Prior history of non-adherence to prescribed drug regimens.
- •- Previous cardioversion needed> 48 hours after the onset of AF / AT.
- •-Women of childbearing potential who are pregnant, breast-feeding or plan to become pregnant during the course of the trial.
研究者
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