ATrial FibrillaTion ProgrESsion Trial(ATTEST Trial) - ATTEST

Biosense Webster, Inc.0 个研究点目标入组 255 人开始时间: 2013年1月3日最近更新: 2020年12月14日

适应症

试验速览

暂无简介。

•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

•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.

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