Clinical trial NCT03991754: Prevention of New Onset AF After TAVI (PAF-TAVI Trial)
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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Atrial Fibrillation New Onset
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase III Clinical trial, multiple sites, controlled, randomized, double blind, parallel groups.
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Incidence of new onset atrial fibrillation
timeFrame: 30 days after transcatheter aortic valve implantation (TAVI)
Secondary outcomes:
measure: Incidence of new onset atrial fibrillation
timeFrame: 60 days after transcatheter aortic valve implantation (TAVI)
measure: Effect of the amiodarone
timeFrame: 1-year follow-up
measure: Mortality and CV mortality.
timeFrame: 1-year follow-up
measure: Number of parients with MACE
timeFrame: at 30 days after NOAF
measure: Number of parients with MACE
timeFrame: at 60 days after NOAF
measure: Number of parients with MACE
timeFrame: at 6 months after NOAF
measure: Number of parients with MACE
timeFrame: 1-year follow-up
measure: Number of adverse events related to amiodarone
timeFrame: at 30 days after NOAF
measure: Number of adverse events related to amiodarone
timeFrame: at 60 days after NOAF
measure: Number of adverse events related to amiodarone
timeFrame: at 6 months after NOAF
measure: Number of adverse events related to amiodarone
timeFrame: 1-year follow-up
measure: Incidence of permanent pacemaker implantation in the both groups.
timeFrame: at 30 days after NOAF
measure: Incidence of permanent pacemaker implantation in the both groups.
timeFrame: at 60 days after NOAF
measure: Incidence of permanent pacemaker implantation in the both groups.
timeFrame: at 6 months after NOAF
measure: Incidence of permanent pacemaker implantation in the both groups.
timeFrame: 1-year follow-up
measure: Quality of life: EuroQoL 5D
timeFrame: at 30 days after NOA
measure: Quality of life: Kansas City test
timeFrame: at 30 days after NOA
measure: Quality of life: EuroQoL 5D
timeFrame: at 60 days after NOAF
measure: Quality of life: Kansas City test
timeFrame: at 60 days after NOAF
measure: Quality of life: EuroQoL 5D
timeFrame: at 6 months after NOAF
measure: Quality of life: Kansas City test
timeFrame: at 6 months after NOAF
measure: Quality of life: EuroQoL 5D
timeFrame: 1-year follow-up
measure: Quality of life: Kansas City test
timeFrame: 1-year follow-up
measure: Readmissions due to CV causes
timeFrame: 1-year follow-up
measure: Functional change: New York Heart Association.
timeFrame: at 30 days after NOA
measure: Functional change: New York Heart Association.
timeFrame: at 60 days after NOAF
measure: Functional change: New York Heart Association.
timeFrame: at 6 months after NOAF
measure: Functional change: New York Heart Association.
timeFrame: 1-year follow-up
measure: Capacity for the exercise
timeFrame: at 30 days after NOA
measure: Capacity for the exercise
timeFrame: at 60 days after NOAF
measure: Capacity for the exercise
timeFrame: at 6 months after NOAF
measure: Capacity for the exercise
timeFrame: 1-year follow-up
measure: Incidence of Acute renal failure
timeFrame: baseline
measure: Incidence of Acute renal failure
timeFrame: 30 days after NOA
Other outcomes:
Locations:
Study officials:
References: