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

NCT03991754 | Unknown Phase 3

• 1 other identifier: 19/147-R_M
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Incidence of new onset atrial fibrillation

  Compare the incidence of new onset atrial fibrillation (NOAF) on patients that receive oral amiodarone versus placebo. 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.

  30 days after transcatheter aortic valve implantation (TAVI)

Secondary Outcomes (34)

• Incidence of new onset atrial fibrillation

  60 days after transcatheter aortic valve implantation (TAVI)

• Effect of the amiodarone

  1-year follow-up

• Mortality and CV mortality.

  1-year follow-up

• Number of parients with MACE

  at 30 days after NOAF

• Number of parients with MACE

  at 60 days after NOAF

Study Arms (2)

Amiodarone

EXPERIMENTAL

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.

Procedure: transcatheter aortic valve implantation

Control

PLACEBO COMPARATOR

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

Procedure: transcatheter aortic valve implantation

Interventions

transcatheter aortic valve implantation PROCEDURE

transcatheter aortic valve implantation

Amiodarone; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Luis Nombela Franco: lead

MeSH Terms

Interventions

Transcatheter Aortic Valve Replacement

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Central Study Contacts

Luis Nombela Franco, PhD

CONTACT

913303000; luisnombela@yahoo.com

Gabriela Tirado-Conte, MD

CONTACT

913303000; gabrielatirado@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Phase III Clinical trial, multiple sites, controlled, randomized, double blind, parallel groups.

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 19, 2019
• Study Start: June 30, 2019
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: June 19, 2019

Record last verified: 2019-06