Symptomatic persistent atrial fibrillation: atrial fibrillation, that lasts longer than 7 days, including episodes that are terminated by cardioversion, either with drugs or by direct current cardioversion, after 7 days or more. Episodes of atrial fibrillation have to be accompanied by symptoms. MedDRA version: 20.0 Level: LLT Classification code 10071667 Term: Persistent atrial fibrillation System Organ Class: 100000004849
Conditions
Interventions
Trade Name: Aristocor
Product Name: Aristocor® 100 mg
Product Code: Not applicable
Pharmaceutical Form: Tablet
INN or Proposed INN: Flecainidacetat
CAS Number: 54143-56-5
Other descriptive name: FLECA
Sponsors
AZ Sint-Jan Brugge-Oostende AV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient with symptomatic persistent AF, resistant to ongoing or prior ADT (failed ADT) Patients is considered to have persistent AF if the patient has suffered any prior AF episode =7 days (ESC 2016 guidelines). 2. Before PVI, there was at least one episode of persistent AF in the last year. 3. Signed Patient Informed Consent Form. 4. Age 18 years or older. 5. Able and willing to comply with all follow-up testing and requirements. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 160
Exclusion criteria
Exclusion criteria: 1. Patients not willing or not suited to take any class IC or III ADT. 2. Any prior AF episode =12 months, or any recurrence of AF 50mm LV ejection fraction 15mm 4. BMI >35 5. Recent (<3 months) CABG, myocardial infarction, CVA, uncontrolled heart failure or angina 6. Active illness or systemic infection or sepsis 7. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause 8. Awaiting cardiac transplantation or other cardiac surgery 9. Documented left atrial thrombus or atrial myxoma on imaging 10. History of blood clotting or bleeding abnormalities 11. Enrollment in any other study evaluating another device or drug 12. Women with childbearing potential 13. Life expectancy less than 12 months 14. Contraindication for catheter ablation (intramural thrombus, tumor or other abnormality that precludes catheter introduction, contraindication to anticoagulation therapy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We aimed to study whether continued ADT (antiarrhythmic drug treatment) (ADT ON) beyond the 3 month blanking period reduces recurrrence of atrial tachyarrhyhtmia (ATA) in the first year after contact-force guided pulmonary vein isolation (PVI) for persistent AF.;Secondary Objective: Secondary Endpoints: Time to persistent AF ATA recurrence in patients with early peristent AF (defined as AF =3 months) Incidence of repeat ablation Unscheduled visits and hospitalisation ADT or ablation related adverse events QOL and symptoms Outcome after repeat ablation ;Primary end point(s): Primary Endpoint: Any documented ATA (atrial fibrillation, AF, atrial tachycardia, AT, atrial flutter, AFL) lasting >30s from 3 months through 12 month follow-up after the first procedure ;Timepoint(s) of evaluation of this end point: - Enrollment - (T0) PVI - (T1) 1 month - (T3) 3 months +/- 30days - (T6) 6 months +/- 30days - (T12) 12 months +/- 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints: Time to persistent AF ATA recurrence in patients with early peristent AF (defined as AF =3 months) Incidence of repeat ablation Unscheduled visits and hospitalisation ADT or ablation related adverse events QOL and symptoms Outcome after repeat ablation ;Timepoint(s) of evaluation of this end point: - Enrollment - (T0) PVI - (T1) 1 month - (T3) 3 months +/- 30days - (T6) 6 months +/- 30days - (T12) 12 months +/- 30 days | — |
Countries
Austria, Denmark, France, Spain
Contacts
Public ContactAnthony Demolder
Anthony Demolder
Outcome results
None listed