- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03991754
Prevention of New Onset AF After TAVI (PAF-TAVI Trial) (PAF-TAVI)
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Luis Nombela Franco, PhD
- Phone Number: 3283 913303000
- Email: luisnombela@yahoo.com
Study Contact Backup
- Name: Gabriela Tirado-Conte, MD
- Phone Number: 3283 913303000
- Email: gabrielatirado@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19/147-R_M
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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