sefulness of amiodarone for the Prevention of new onset Atrial Fibrillation after transcatheter aortic valve implantation: a randomized controlled trial

uis Nombela Franco0 个研究点目标入组 120 人开始时间: 2019年6月11日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•1. Men and women over 18 years old. Women of childbearing age must commit to the use of contraceptive methods of assured efficacy.
•2.Patients that will undergo TAVI due to aortic stenosis.
•3.Sinus rhythm showed by an ECG during 72 hours previous to the inclusion in the study.
•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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•1.Pregnancy or lactation. Women of childbearing age who do not have a negative pregnancy test.
•2.Paroxysmal or persistent AF (documented record in electrocardiogram or ECG holter)
•3.Congestive heart failure with functional class NYHA IV despite optimal medical treatment.
•4.Sustained hypotension (TAS < 80mmHg)
•5.Severe mitral stenosis or regurgitation
•6.Treatment with antiarrhythmic drugs (amiodarone included) 3 months before the procedure, treatment with beta-blockers or dihydropyrimidine calcium channel blockers are not considered an exclusion criteria.
•7.Sinus bradycardia (< 50 lpm), PR interval >240 mseg or second or third degree AV block.
•8.QT interval longer than 480 msec in an EKG performed in 72 hours before the inclusion, without a permanent pacemaker.
•9.Clinical hypo- or hyperthyroidism.
•10.Allergy or adverse reaction known or suspected to the amiodarone.
•11.Denial of the patient or inability to give informed consent.

发起方

uis Nombela Franco