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

June 17, 2019 updated by: Luis Nombela Franco

Usefulness of Amiodarone for the Prevention of New Onset Atrial Fibrillation After Transcatheter Aortic Valve Implantation: a Randomized Controlled Trial

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
transcatheter aortic valve implantation
Placebo Comparator: 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
transcatheter aortic valve implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of new onset atrial fibrillation
Time Frame: 30 days after transcatheter aortic valve implantation (TAVI)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of new onset atrial fibrillation
Time Frame: 60 days after transcatheter aortic valve implantation (TAVI)
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.
60 days after transcatheter aortic valve implantation (TAVI)
Effect of the amiodarone
Time Frame: 1-year follow-up
Analyze the effect of the amiodarone in the moment of appearance and the burden of AF after TAVI. AF burden, defined as the relative length of the AF registers in relation to the time in sinus rhythm.
1-year follow-up
Mortality and CV mortality.
Time Frame: 1-year follow-up
Compare all-cause mortality and CV mortality between groups.
1-year follow-up
Number of parients with MACE
Time Frame: at 30 days after NOAF
MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate.
at 30 days after NOAF
Number of parients with MACE
Time Frame: at 60 days after NOAF
MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate.
at 60 days after NOAF
Number of parients with MACE
Time Frame: at 6 months after NOAF
MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate.
at 6 months after NOAF
Number of parients with MACE
Time Frame: 1-year follow-up
MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate.
1-year follow-up
Number of adverse events related to amiodarone
Time Frame: at 30 days after NOAF
The safety evaluation will be realized by a meticulous vigilance of the adverse effects appeared in the study population.
at 30 days after NOAF
Number of adverse events related to amiodarone
Time Frame: at 60 days after NOAF
The safety evaluation will be realized by a meticulous vigilance of the adverse effects appeared in the study population.
at 60 days after NOAF
Number of adverse events related to amiodarone
Time Frame: at 6 months after NOAF
The safety evaluation will be realized by a meticulous vigilance of the adverse effects appeared in the study population.
at 6 months after NOAF
Number of adverse events related to amiodarone
Time Frame: 1-year follow-up
The safety evaluation will be realized by a meticulous vigilance of the adverse effects appeared in the study population.
1-year follow-up
Incidence of permanent pacemaker implantation in the both groups.
Time Frame: at 30 days after NOAF
Need of permanent pacemaker implantation in the both groups.
at 30 days after NOAF
Incidence of permanent pacemaker implantation in the both groups.
Time Frame: at 60 days after NOAF
Need of permanent pacemaker implantation in the both groups.
at 60 days after NOAF
Incidence of permanent pacemaker implantation in the both groups.
Time Frame: at 6 months after NOAF
Need of permanent pacemaker implantation in the both groups.
at 6 months after NOAF
Incidence of permanent pacemaker implantation in the both groups.
Time Frame: 1-year follow-up
Need of permanent pacemaker implantation in the both groups.
1-year follow-up
Quality of life: EuroQoL 5D
Time Frame: at 30 days after NOA
Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1.
at 30 days after NOA
Quality of life: Kansas City test
Time Frame: at 30 days after NOA
Score between 0 and 100. The best score 100.
at 30 days after NOA
Quality of life: EuroQoL 5D
Time Frame: at 60 days after NOAF
Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1.
at 60 days after NOAF
Quality of life: Kansas City test
Time Frame: at 60 days after NOAF
Score between 0 and 100. The best score 100.
at 60 days after NOAF
Quality of life: EuroQoL 5D
Time Frame: at 6 months after NOAF
Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1.
at 6 months after NOAF
Quality of life: Kansas City test
Time Frame: at 6 months after NOAF
Score between 0 and 100. The best score 100.
at 6 months after NOAF
Quality of life: EuroQoL 5D
Time Frame: 1-year follow-up
Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1.
1-year follow-up
Quality of life: Kansas City test
Time Frame: 1-year follow-up
Score between 0 and 100. The best score 100.
1-year follow-up
Readmissions due to CV causes
Time Frame: 1-year follow-up
Compare the number of readmissions due to CV causes
1-year follow-up
Functional change: New York Heart Association.
Time Frame: at 30 days after NOA
Evaluate the functional change according to the NYHA scale. Score between 0 and 4. The best score 1.
at 30 days after NOA
Functional change: New York Heart Association.
Time Frame: at 60 days after NOAF
Evaluate the functional change according to the NYHA scale. Score between 0 and 4. The best score 1.
at 60 days after NOAF
Functional change: New York Heart Association.
Time Frame: at 6 months after NOAF
Evaluate the functional change according to the NYHA scale. Score between 0 and 4. The best score 1.
at 6 months after NOAF
Functional change: New York Heart Association.
Time Frame: 1-year follow-up
Evaluate the functional change according to the NYHA scale. Score between 0 and 4. The best score 1.
1-year follow-up
Capacity for the exercise
Time Frame: at 30 days after NOA
Evalue the change in capacity for the exercise, evaluated by the 6-minute walk test between groups
at 30 days after NOA
Capacity for the exercise
Time Frame: at 60 days after NOAF
Evalue the change in capacity for the exercise, evaluated by the 6-minute walk test between groups
at 60 days after NOAF
Capacity for the exercise
Time Frame: at 6 months after NOAF
Evalue the change in capacity for the exercise, evaluated by the 6-minute walk test between groups
at 6 months after NOAF
Capacity for the exercise
Time Frame: 1-year follow-up
Evalue the change in capacity for the exercise, evaluated by the 6-minute walk test between groups
1-year follow-up
Incidence of Acute renal failure
Time Frame: baseline
Compare the number of events due to acute renal failure between groups
baseline
Incidence of Acute renal failure
Time Frame: 30 days after NOA
Compare the number of events due to acute renal failure between groups
30 days after NOA

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 30, 2019

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

May 30, 2019

First Submitted That Met QC Criteria

June 17, 2019

First Posted (Actual)

June 19, 2019

Study Record Updates

Last Update Posted (Actual)

June 19, 2019

Last Update Submitted That Met QC Criteria

June 17, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 19/147-R_M

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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