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

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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004202-25-ES

Enrollment

120

Registered

2019-06-11

Start date

2019-06-05

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atrial fibrillation MedDRA version: 20.0 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: AMIODARONA AUROVITAS Pharmaceutical Form: Tablet INN or Proposed INN: AMIODARONE HYDROCHLORIDE CAS Number: 19774-82-4 Concen

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: compare the incidence of new onset atrial fibrillation (NOAF) at 30 days after transcatheter aortic valve implantation (TAVI) on patients that recieve oral amiodarone versus placebo.; Secondary Objective: -Evaluate the effect of the amiodarone in the incidence of NOAF 60 after TAVI . -Analyze the effect of the amiodarone in the moment of appearance and the burden of AF after TAVI. -Compare all-cause mortality and CV mortality between groups. -Compare the combined end-point MACE (death, stroke or major or life-threatening bleeding according to VARC-2 criteria). -Assess the effectiveness of the amiodarone in the reduction of the hospital stay after the procedure. -Analyze the safety of the treatment with amiodarone in patients undergoing TAVI. -Assess the incidence of permanent pacemaker implantation in the both groups. -Compare EuroQoL 5D and Kansas City questionnaires between groups. -Compare the number of readmissions due to CV causes. -Evaluate the functional change according to the NYHA scale between both groups. -Value the change in capacity for the exercise, evaluated by the 6-minute walk test between groups. -Compare the events of acute renal failure between groups. ;Primary end point(s): NOAF is defined as an irregular rhythm without P wave and irregular ventricular response during at least 30 seconds, detected in the electrocardiographic monitoring during the post-procedural period or in the 60 days ECG Holter in a patient without previous history of atrial fibrillation. NOAF incidence within 30-day after the TAVI procedure is the primary end-point.;Timepoint(s) of evaluation of this end point: 30-day after the TAVI procedure	—

Measure

Time frame

Main Objective: compare the incidence of new onset atrial fibrillation (NOAF) at 30 days after transcatheter aortic valve implantation (TAVI) on patients that recieve oral amiodarone versus placebo.; Secondary Objective: -Evaluate the effect of the amiodarone in the incidence of NOAF 60 after TAVI . -Analyze the effect of the amiodarone in the moment of appearance and the burden of AF after TAVI. -Compare all-cause mortality and CV mortality between groups. -Compare the combined end-point MACE (death, stroke or major or life-threatening bleeding according to VARC-2 criteria). -Assess the effectiveness of the amiodarone in the reduction of the hospital stay after the procedure. -Analyze the safety of the treatment with amiodarone in patients undergoing TAVI. -Assess the incidence of permanent pacemaker implantation in the both groups. -Compare EuroQoL 5D and Kansas City questionnaires between groups. -Compare the number of readmissions due to CV causes. -Evaluate the functional change according to the NYHA scale between both groups. -Value the change in capacity for the exercise, evaluated by the 6-minute walk test between groups. -Compare the events of acute renal failure between groups. ;Primary end point(s): NOAF is defined as an irregular rhythm without P wave and irregular ventricular response during at least 30 seconds, detected in the electrocardiographic monitoring during the post-procedural period or in the 60 days ECG Holter in a patient without previous history of atrial fibrillation. NOAF incidence within 30-day after the TAVI procedure is the primary end-point.;Timepoint(s) of evaluation of this end point: 30-day after the TAVI procedure

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Secondary

Measure	Time frame
Secondary end point(s): 1.NOAF incidence at 60-day after TAVI. 2.Time until atrial fibrillation appearance 3.AF burden, defined as the relative length of the AF registers in relation to the time in sinus rhythm. 4.Need for a permanent pacemaker implantation during the hospitalization, and at 30-, 60-day and 1-year follow-up 5.Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate at 30-, 60-day, 6 months and 1-year follow-up. 6. The safety evaluation will be realized by a meticulous vigilance of the adverse effects appeared in the study population. 7. hospital stay after the procedure in patients undergoing TAVI. 8. EuroQOL 5D and Heart Failure Questionnaire (Kansas City) at 30 and 60 days and at 12 months after the procedure . 9.readmissions due to cardiovascular causes. 10.change of functional status according to the NYHA scale with respect to the baseline functional class at month, at 2, 6 and 12 months. 11.change in capacity for the exercise, evaluated by the 6-minute walk test, 30 days, 60 days and one year of follow-up, compared to baseline. 12.acute renal failure during admission and 30 days postprocedure. ; Timepoint(s) of evaluation of this end point: 1. 60-day after TAVI. 2.Time until atrial fibrillation appearance 4. during the hospitalization, and at 30-, 60-day and 1-year follow-up 5. at 30-, 60-day, 6 months and 1-year follow-up. 6.since tretament start until last follow-up visit. 7.hospital discharge. 8.at 30 and 60 days and at 12 months after the procedure . 10.baseline, at 1, 2, 6 and 12 months. 11.30 days, 60 days and one year of follow-up, compared to baseline. 12.dur	—

Measure

Time frame

Secondary end point(s): 1.NOAF incidence at 60-day after TAVI. 2.Time until atrial fibrillation appearance 3.AF burden, defined as the relative length of the AF registers in relation to the time in sinus rhythm. 4.Need for a permanent pacemaker implantation during the hospitalization, and at 30-, 60-day and 1-year follow-up 5.Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate at 30-, 60-day, 6 months and 1-year follow-up. 6. The safety evaluation will be realized by a meticulous vigilance of the adverse effects appeared in the study population. 7. hospital stay after the procedure in patients undergoing TAVI. 8. EuroQOL 5D and Heart Failure Questionnaire (Kansas City) at 30 and 60 days and at 12 months after the procedure . 9.readmissions due to cardiovascular causes. 10.change of functional status according to the NYHA scale with respect to the baseline functional class at month, at 2, 6 and 12 months. 11.change in capacity for the exercise, evaluated by the 6-minute walk test, 30 days, 60 days and one year of follow-up, compared to baseline. 12.acute renal failure during admission and 30 days postprocedure. ; Timepoint(s) of evaluation of this end point: 1. 60-day after TAVI. 2.Time until atrial fibrillation appearance 4. during the hospitalization, and at 30-, 60-day and 1-year follow-up 5. at 30-, 60-day, 6 months and 1-year follow-up. 6.since tretament start until last follow-up visit. 7.hospital discharge. 8.at 30 and 60 days and at 12 months after the procedure . 10.baseline, at 1, 2, 6 and 12 months. 11.30 days, 60 days and one year of follow-up, compared to baseline. 12.dur

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Countries

Spain

Contacts

Public ContactPrincipal Investigator

Luis Nombela Franco

luisnombela@yahoo.com0034629510139

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026