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

NCT ID: NCT03991754

Last Updated: 2019-06-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-30
• Study Completion Date: 2022-06-30

Brief Summary

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.

Conditions

Atrial Fibrillation New Onset

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Amiodarone

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.

Group Type: EXPERIMENTAL

transcatheter aortic valve implantation

Intervention Type: PROCEDURE

transcatheter aortic valve implantation

Control

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

Group Type: PLACEBO_COMPARATOR

transcatheter aortic valve implantation

Intervention Type: PROCEDURE

transcatheter aortic valve implantation

Interventions

transcatheter aortic valve implantation

transcatheter aortic valve implantation

Intervention Type: PROCEDURE

Eligibility Criteria

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Luis Nombela Franco

OTHER

Sponsor Role: lead

Responsible Party

Luis Nombela Franco

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Luis Nombela Franco, PhD

Role: CONTACT

luisnombela@yahoo.com

913303000 ext. 3283

Gabriela Tirado-Conte, MD

Role: CONTACT

gabrielatirado@gmail.com

913303000 ext. 3283

Other Identifiers

19/147-R_M

Identifier Type: -

Identifier Source: org_study_id