Prevention of New Onset AF After TAVI (PAF-TAVI Trial)

Luis Nombela Franco

Status and phase: Unknown; Phase 3

Conditions: Atrial Fibrillation New Onset

Treatments: Procedure: transcatheter aortic valve implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03991754

19/147-R_M

Details and patient eligibility

About

New onset atrial fibrillation (NOAF) is a relatively frequent complication after transcatheter aortic valve implantation (TAVI). This complication has been related with worse short and long-term outcomes, including higher stroke, mortality, readmission and bleeding rates. The aim of this study is to evaluate the effectiveness of amiodarone in the prevention of the NOAF after TAVI.

The study is a multicenter, randomized double-blinded trial including 120 patients without prior AF that will undergo TAVI in a scheduled basis. Patients will be randomized to be treated with amiodarone orally from 6 days before to 6 days after the TAVI procedure versus placebo.

All the patients will be monitored with a 60-day holter to evaluate NOAF incidence. The main objective is NOAF incidence after TAVI at 30-day. Secondary endpoints are the incidence of NOAF, stroke, bleeding and all-cause and cardiovascular mortality in both groups at 60-day. Results of this study can contribute to optimize TAVI results in a short and long term, potentially improving the survival and quality of life in this group of frail patients with comorbidities, which makes them vulnerable to NOAF, stroke, bleeding, heart failure and readmission.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women over 18 years old. Women of childbearing age must commit to the use of contraceptive methods of assured efficacy.
• Patients that will undergo TAVI due to aortic stenosis.
• Sinus rhythm showed by an ECG during 72 hours previous to the inclusion in the study.

Exclusion criteria

• Pregnancy or lactation. Women of childbearing age who do not have a negative pregnancy test.
• Paroxysmal persistent or persistent AF (documented record in electrocardiogram or ECG holter)
• Congestive heart failure with functional class NYHA IV despite optimal medical treatment.
• Sustained hypotension (TAS < 80mmHg)
• Severe mitral stenosis or regurgitation
• 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.
• Sinus bradycardia (< 50 lpm), PR interval >240 mseg or second or third degree AV block.
• QT interval longer than 480 msec in an EKG performed in 72 hours before the inclusion, without a permanent pacemaker.
• Clinical hypo- or hyperthyroidism, clinical or subclinical autoimmune thyroid disease, or multinodular goiter.
• Allergy or adverse reaction known or suspected to the amiodarone.
• Denial of the patient or inability to give informed consent.
• Hypersensitivity to iodo
• Concomitant drugs that, in association with amiodarone, can induce torsades de pointes

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups, including a placebo group

Amiodarone

Experimental group

Description:

Oral Amiodarone 600mg / day, divided into 3 doses (200mg every 8 hours) for 6 days before the procedure and then 400mg / day, divided into 2 doses (200mg every 12 hours) during the 6 days following the implantation of TAVI.

Treatment:

Procedure: transcatheter aortic valve implantation

Control

Placebo Comparator group

Description:

Patients assigned to the control group will receive placebo tablets identical to those of amiodarone. The administration of these tablets will follow the same scheme as in the amiodarone group. Therefore, they will receive placebo tablets orally, 1 tablet every 8 hours 6 days before the procedure and then 1 tablet every 12 hours during the 6 days following the implantation of TAVI

Treatment:

Procedure: transcatheter aortic valve implantation