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

Atrial Fibrillation New Onset Clinical Trial

— PAF-TAVI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03991754
• Other study ID #: 19/147-R_M
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 30, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: June 2019
• Source: Hospital San Carlos, Madrid
• Contact: Luis Nombela Franco, PhD
• Phone: 913303000
• Email: luisnombela[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation New Onset

Intervention

Procedure:
• transcatheter aortic valve implantation
transcatheter aortic valve implantation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Luis Nombela Franco

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	60 days after transcatheter aortic valve implantation (TAVI)
Secondary	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.	1-year follow-up
Secondary	Mortality and CV mortality.	Compare all-cause mortality and CV mortality between groups.	1-year follow-up
Secondary	Number of parients with MACE	MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate.	at 30 days after NOAF
Secondary	Number of parients with MACE	MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate.	at 60 days after NOAF
Secondary	Number of parients with MACE	MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate.	at 6 months after NOAF
Secondary	Number of parients with MACE	MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate.	1-year follow-up
Secondary	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.	at 30 days after NOAF
Secondary	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.	at 60 days after NOAF
Secondary	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.	at 6 months after NOAF
Secondary	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.	1-year follow-up
Secondary	Incidence of permanent pacemaker implantation in the both groups.	Need of permanent pacemaker implantation in the both groups.	at 30 days after NOAF
Secondary	Incidence of permanent pacemaker implantation in the both groups.	Need of permanent pacemaker implantation in the both groups.	at 60 days after NOAF
Secondary	Incidence of permanent pacemaker implantation in the both groups.	Need of permanent pacemaker implantation in the both groups.	at 6 months after NOAF
Secondary	Incidence of permanent pacemaker implantation in the both groups.	Need of permanent pacemaker implantation in the both groups.	1-year follow-up
Secondary	Quality of life: EuroQoL 5D	Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1.	at 30 days after NOA
Secondary	Quality of life: Kansas City test	Score between 0 and 100. The best score 100.	at 30 days after NOA
Secondary	Quality of life: EuroQoL 5D	Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1.	at 60 days after NOAF
Secondary	Quality of life: Kansas City test	Score between 0 and 100. The best score 100.	at 60 days after NOAF
Secondary	Quality of life: EuroQoL 5D	Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1.	at 6 months after NOAF
Secondary	Quality of life: Kansas City test	Score between 0 and 100. The best score 100.	at 6 months after NOAF
Secondary	Quality of life: EuroQoL 5D	Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1.	1-year follow-up
Secondary	Quality of life: Kansas City test	Score between 0 and 100. The best score 100.	1-year follow-up
Secondary	Readmissions due to CV causes	Compare the number of readmissions due to CV causes	1-year follow-up
Secondary	Functional change: New York Heart Association.	Evaluate the functional change according to the NYHA scale. Score between 0 and 4. The best score 1.	at 30 days after NOA
Secondary	Functional change: New York Heart Association.	Evaluate the functional change according to the NYHA scale. Score between 0 and 4. The best score 1.	at 60 days after NOAF
Secondary	Functional change: New York Heart Association.	Evaluate the functional change according to the NYHA scale. Score between 0 and 4. The best score 1.	at 6 months after NOAF
Secondary	Functional change: New York Heart Association.	Evaluate the functional change according to the NYHA scale. Score between 0 and 4. The best score 1.	1-year follow-up
Secondary	Capacity for the exercise	Evalue the change in capacity for the exercise, evaluated by the 6-minute walk test between groups	at 30 days after NOA
Secondary	Capacity for the exercise	Evalue the change in capacity for the exercise, evaluated by the 6-minute walk test between groups	at 60 days after NOAF
Secondary	Capacity for the exercise	Evalue the change in capacity for the exercise, evaluated by the 6-minute walk test between groups	at 6 months after NOAF
Secondary	Capacity for the exercise	Evalue the change in capacity for the exercise, evaluated by the 6-minute walk test between groups	1-year follow-up
Secondary	Incidence of Acute renal failure	Compare the number of events due to acute renal failure between groups	baseline
Secondary	Incidence of Acute renal failure	Compare the number of events due to acute renal failure between groups	30 days after NOA