EUCTR2012-002338-35-SE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
- 330
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 = 2 episodes over the last
- •6 months; 1 episode within the last 1 year (12 months) must be
- •documented by electrocardiogram (ECG), TTM, HM, or telemetry strip.
- •HATCH Score of at least =1 and = 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 = 55mm by TTE.
- •LV ejection fraction = 50% when in sinus rhythm or LV ejection
- •fraction = 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.
研究者
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