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

Last updated: June 17, 2019
Sponsor: Luis Nombela Franco
Overall Status: Active - Not Recruiting

Phase

3

Condition

Atrial Fibrillation

Cardiac Disease

Chest Pain

Treatment

N/A

Clinical Study ID

NCT03991754
19/147-R_M
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Men and women over 18 years old. Women of childbearing age must commit to the use ofcontraceptive 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

Exclusion Criteria:

  • Pregnancy or lactation. Women of childbearing age who do not have a negative pregnancytest.

  • Paroxysmal persistent or persistent AF (documented record in electrocardiogram or ECGholter)

  • Congestive heart failure with functional class NYHA IV despite optimal medicaltreatment.

  • Sustained hypotension (TAS < 80mmHg)

  • Severe mitral stenosis or regurgitation

  • Treatment with antiarrhythmic drugs (amiodarone included) 3 months before theprocedure, treatment with beta-blockers or dihydropyrimidine calcium channel blockersare not considered an exclusion criteria.

  • Sinus bradycardia (< 50 lpm), PR interval >240 mseg or second or third degree AVblock.

  • 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 Design

Total Participants: 120
Study Start date:
June 30, 2019
Estimated Completion Date:
June 30, 2022