Continuing versus stopping heart rhythm medication after an operation restoring your normal heart rhythm in patients with a heart rhythm disorder: a study across multiple hospitals.

Phase 1

Conditions: 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: 20.0Level: LLTClassification code 10071667Term: Persistent atrial fibrillationSystem Organ Class: 100000004849
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2018-002103-33-DK

Lead Sponsor: AZ Sint-Jan Brugge-Oostende AV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 220

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

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 <3 days after cardioversion.
3. Presence of structural heart disease on echo criteria:
severe valvular heart disease
LA size >50mm
LV ejection fraction <35% (except if suspected tachycardiomyopathy)
septal diameter >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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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: <br>Time to persistent AF<br>ATA recurrence in patients with early peristent AF (defined as AF =3 months)<br>Incidence of repeat ablation<br>Unscheduled visits and hospitalisation<br>ADT or ablation related adverse events<br>QOL and symptoms <br>Outcome after repeat ablation<br>;Primary end point(s): Primary Endpoint: <br>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 <br>- (T0) PVI <br>- (T1) 1 month<br>- (T3) 3 months +/- 30days<br>- (T6) 6 months +/- 30days<br>- (T12) 12 months +/- 30 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary Endpoints: <br>Time to persistent AF<br>ATA recurrence in patients with early peristent AF (defined as AF =3 months)<br>Incidence of repeat ablation<br>Unscheduled visits and hospitalisation<br>ADT or ablation related adverse events<br>QOL and symptoms <br>Outcome after repeat ablation<br>;Timepoint(s) of evaluation of this end point: - Enrollment <br>- (T0) PVI <br>- (T1) 1 month<br>- (T3) 3 months +/- 30days<br>- (T6) 6 months +/- 30days<br>- (T12) 12 months +/- 30 days

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