EUCTR2012-002338-35-IE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
- •1. Patients with recurrent paroxysmal AF for at least 2 years, with = 2 episodes over the last 6 months;
- •2. HATCH Score of at least =1 and = 4
- •3. Eligible for catheter ablation and for anti-arrhythmic or rate control medications, after having failed at least 1 but no more than 2 prescribed drugs (either anti-arrhythmic or rate control drug).
- •4. Age 60 years or older.
- •5. Left Atrium diameter = 55mm by Trans Thoracic Echocardiographie.
- •6. Left Ventricule ejection fraction = 50% when in sinus rhythm or LV ejection fraction = 35% when in AF.
- •7. Patient signed the Informed Consent Form and is able and willing to comply with protocol requirements, including all baseline and follow- up 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
- •1.Patients awaiting cardiac transplantation or other cardiac surgery.
- •2.Acute illness (ongoing) or active systemic infection or sepsis which in the opinion of the investigator, may adversely
- •affect the safety and/or effectiveness of the participant of the study.
- •3.Reversible causes of AF, e.g. but not limited to thyroid disorders, acute alcohol intoxication, recent major surgical procedures or trauma,…
- •4.Recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3 months.
- •5.Heart failure decompensation.
- •6.Previously diagnosed with persistent/permanent AF/AT
- •7.Previously required cardioversion >48 hours after onset of AF/AT
- •8.Subject having previous TIA or stroke (cerebrovascular accident) one year prior to patient enrolment and/or no
- •sufficient recovery.
- •9.Pulmonary embolism or recent atrial embolism/thrombosis.
- •10.Hypertrophic obstructive cardiomyopathy.
- •11.Class IV angina or Class IV CHF (including past or planned heart transplantation).
- •12.Mandated antiarrhythmic drug therapy for disease conditions other than AF.
- •13.Heritable arrhythmias or increased risk for torsade de pointes with class I or III Drugs.
- •14.Prior LA catheter ablation with the intention of treating AF; prior surgical interventions for AF such as the MAZE
- •15.Prior AV nodal ablation.
- •16.Patients presenting contraindications
- •for the study catheter(s), as indicated in the respective Instructions For Use.
- •17.Contraindication to warfarin, other anticoagulation therapy, or all antiplatelet medications.
- •18.Medical conditions limiting expected survival to < 3 years.
- •19.Concurrent participation in any other clinical study.
- •20.Prior history of nonadherence
- •to prescribed drug regimens.
- •21.Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial
研究者
相似试验
进行中（未招募）
1 期
Atrial Fibrillation Progression TrialMedDRA version: 16.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disordersAtrial FibrillationEUCTR2012-002338-35-DEBiosense Webster, Inc.255
进行中（未招募）
1 期
Atrial Fibrillation Progression TrialAtrial FibrillationEUCTR2012-002338-35-ATBiosense Webster, Inc.330
进行中（未招募）
1 期
Atrial Fibrillation Progression TrialMedDRA version: 16.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disordersAtrial FibrillationEUCTR2012-002338-35-CZBiosense Webster, Inc.255
进行中（未招募）
1 期
Atrial Fibrillation Progression TrialAtrial FibrillationEUCTR2012-002338-35-SEBiosense Webster, Inc.330
进行中（未招募）
1 期
Atrial Fibrillation Progression TrialAtrial FibrillationEUCTR2012-002338-35-ESBiosense Webster, Inc.255