Back to resultsPrevention of New Onset AF After TAVI (PAF-TAVI Trial) (PAF-TAVI)
Primary Purpose
Atrial Fibrillation New Onset
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
transcatheter aortic valve implantation
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation New Onset
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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Amiodarone
Control
Arm 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.
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Effect of the amiodarone
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.
Mortality and CV mortality.
Compare all-cause mortality and CV mortality between groups.
Number of parients with MACE
MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate.
Number of parients with MACE
MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate.
Number of parients with MACE
MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate.
Number of parients with MACE
MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate.
Number of adverse events related to amiodarone
The safety evaluation will be realized by a meticulous vigilance of the adverse effects appeared in the study population.
Number of adverse events related to amiodarone
The safety evaluation will be realized by a meticulous vigilance of the adverse effects appeared in the study population.
Number of adverse events related to amiodarone
The safety evaluation will be realized by a meticulous vigilance of the adverse effects appeared in the study population.
Number of adverse events related to amiodarone
The safety evaluation will be realized by a meticulous vigilance of the adverse effects appeared in the study population.
Incidence of permanent pacemaker implantation in the both groups.
Need of permanent pacemaker implantation in the both groups.
Incidence of permanent pacemaker implantation in the both groups.
Need of permanent pacemaker implantation in the both groups.
Incidence of permanent pacemaker implantation in the both groups.
Need of permanent pacemaker implantation in the both groups.
Incidence of permanent pacemaker implantation in the both groups.
Need of permanent pacemaker implantation in the both groups.
Quality of life: EuroQoL 5D
Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1.
Quality of life: Kansas City test
Score between 0 and 100. The best score 100.
Quality of life: EuroQoL 5D
Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1.
Quality of life: Kansas City test
Score between 0 and 100. The best score 100.
Quality of life: EuroQoL 5D
Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1.
Quality of life: Kansas City test
Score between 0 and 100. The best score 100.
Quality of life: EuroQoL 5D
Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1.
Quality of life: Kansas City test
Score between 0 and 100. The best score 100.
Readmissions due to CV causes
Compare the number of readmissions due to CV causes
Functional change: New York Heart Association.
Evaluate the functional change according to the NYHA scale. Score between 0 and 4. The best score 1.
Functional change: New York Heart Association.
Evaluate the functional change according to the NYHA scale. Score between 0 and 4. The best score 1.
Functional change: New York Heart Association.
Evaluate the functional change according to the NYHA scale. Score between 0 and 4. The best score 1.
Functional change: New York Heart Association.
Evaluate the functional change according to the NYHA scale. Score between 0 and 4. The best score 1.
Capacity for the exercise
Evalue the change in capacity for the exercise, evaluated by the 6-minute walk test between groups
Capacity for the exercise
Evalue the change in capacity for the exercise, evaluated by the 6-minute walk test between groups
Capacity for the exercise
Evalue the change in capacity for the exercise, evaluated by the 6-minute walk test between groups
Capacity for the exercise
Evalue the change in capacity for the exercise, evaluated by the 6-minute walk test between groups
Incidence of Acute renal failure
Compare the number of events due to acute renal failure between groups
Incidence of Acute renal failure
Compare the number of events due to acute renal failure between groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03991754
Brief Title
Prevention of New Onset AF After TAVI (PAF-TAVI Trial)
Acronym
PAF-TAVI
Official Title
Usefulness of Amiodarone for the Prevention of New Onset Atrial Fibrillation After Transcatheter Aortic Valve Implantation: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 30, 2019 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Luis Nombela Franco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation New Onset
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Phase III Clinical trial, multiple sites, controlled, randomized, double blind, parallel groups.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Amiodarone
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Procedure
Intervention Name(s)
transcatheter aortic valve implantation
Intervention Description
transcatheter aortic valve implantation
Primary Outcome Measure Information:
Title
Incidence of new onset atrial fibrillation
Description
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.
Time Frame
30 days after transcatheter aortic valve implantation (TAVI)
Secondary Outcome Measure Information:
Title
Incidence of new onset atrial fibrillation
Description
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.
Time Frame
60 days after transcatheter aortic valve implantation (TAVI)
Title
Effect of the amiodarone
Description
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.
Time Frame
1-year follow-up
Title
Mortality and CV mortality.
Description
Compare all-cause mortality and CV mortality between groups.
Time Frame
1-year follow-up
Title
Number of parients with MACE
Description
MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate.
Time Frame
at 30 days after NOAF
Title
Number of parients with MACE
Description
MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate.
Time Frame
at 60 days after NOAF
Title
Number of parients with MACE
Description
MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate.
Time Frame
at 6 months after NOAF
Title
Number of parients with MACE
Description
MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate.
Time Frame
1-year follow-up
Title
Number of adverse events related to amiodarone
Description
The safety evaluation will be realized by a meticulous vigilance of the adverse effects appeared in the study population.
Time Frame
at 30 days after NOAF
Title
Number of adverse events related to amiodarone
Description
The safety evaluation will be realized by a meticulous vigilance of the adverse effects appeared in the study population.
Time Frame
at 60 days after NOAF
Title
Number of adverse events related to amiodarone
Description
The safety evaluation will be realized by a meticulous vigilance of the adverse effects appeared in the study population.
Time Frame
at 6 months after NOAF
Title
Number of adverse events related to amiodarone
Description
The safety evaluation will be realized by a meticulous vigilance of the adverse effects appeared in the study population.
Time Frame
1-year follow-up
Title
Incidence of permanent pacemaker implantation in the both groups.
Description
Need of permanent pacemaker implantation in the both groups.
Time Frame
at 30 days after NOAF
Title
Incidence of permanent pacemaker implantation in the both groups.
Description
Need of permanent pacemaker implantation in the both groups.
Time Frame
at 60 days after NOAF
Title
Incidence of permanent pacemaker implantation in the both groups.
Description
Need of permanent pacemaker implantation in the both groups.
Time Frame
at 6 months after NOAF
Title
Incidence of permanent pacemaker implantation in the both groups.
Description
Need of permanent pacemaker implantation in the both groups.
Time Frame
1-year follow-up
Title
Quality of life: EuroQoL 5D
Description
Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1.
Time Frame
at 30 days after NOA
Title
Quality of life: Kansas City test
Description
Score between 0 and 100. The best score 100.
Time Frame
at 30 days after NOA
Title
Quality of life: EuroQoL 5D
Description
Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1.
Time Frame
at 60 days after NOAF
Title
Quality of life: Kansas City test
Description
Score between 0 and 100. The best score 100.
Time Frame
at 60 days after NOAF
Title
Quality of life: EuroQoL 5D
Description
Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1.
Time Frame
at 6 months after NOAF
Title
Quality of life: Kansas City test
Description
Score between 0 and 100. The best score 100.
Time Frame
at 6 months after NOAF
Title
Quality of life: EuroQoL 5D
Description
Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1.
Time Frame
1-year follow-up
Title
Quality of life: Kansas City test
Description
Score between 0 and 100. The best score 100.
Time Frame
1-year follow-up
Title
Readmissions due to CV causes
Description
Compare the number of readmissions due to CV causes
Time Frame
1-year follow-up
Title
Functional change: New York Heart Association.
Description
Evaluate the functional change according to the NYHA scale. Score between 0 and 4. The best score 1.
Time Frame
at 30 days after NOA
Title
Functional change: New York Heart Association.
Description
Evaluate the functional change according to the NYHA scale. Score between 0 and 4. The best score 1.
Time Frame
at 60 days after NOAF
Title
Functional change: New York Heart Association.
Description
Evaluate the functional change according to the NYHA scale. Score between 0 and 4. The best score 1.
Time Frame
at 6 months after NOAF
Title
Functional change: New York Heart Association.
Description
Evaluate the functional change according to the NYHA scale. Score between 0 and 4. The best score 1.
Time Frame
1-year follow-up
Title
Capacity for the exercise
Description
Evalue the change in capacity for the exercise, evaluated by the 6-minute walk test between groups
Time Frame
at 30 days after NOA
Title
Capacity for the exercise
Description
Evalue the change in capacity for the exercise, evaluated by the 6-minute walk test between groups
Time Frame
at 60 days after NOAF
Title
Capacity for the exercise
Description
Evalue the change in capacity for the exercise, evaluated by the 6-minute walk test between groups
Time Frame
at 6 months after NOAF
Title
Capacity for the exercise
Description
Evalue the change in capacity for the exercise, evaluated by the 6-minute walk test between groups
Time Frame
1-year follow-up
Title
Incidence of Acute renal failure
Description
Compare the number of events due to acute renal failure between groups
Time Frame
baseline
Title
Incidence of Acute renal failure
Description
Compare the number of events due to acute renal failure between groups
Time Frame
30 days after NOA
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luis Nombela Franco, PhD
Phone
913303000
Ext
3283
Email
luisnombela@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriela Tirado-Conte, MD
Phone
913303000
Ext
3283
Email
gabrielatirado@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Prevention of New Onset AF After TAVI (PAF-TAVI Trial)
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