sefulness of amiodarone for the Prevention of Atrial Fibrillation after implantation of a cardiac valve

Phase 1

• Conditions: atrial fibrillation; MedDRA version: 20.0 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-004202-25-ES
• Lead Sponsor: uis Nombela Franco

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-11
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified