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| Name | Class |
|---|---|
| AZ Sint-Jan AV | OTHER |
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The purpose of this study is to compare the efficacy and safety of PV isolation with continued antiarrhythmic drug treatment (PVI+ADT) to PV isolation without continued ADT (PVI-ADT) in patients undergoing treatment for symptomatic recurrent AF.
Subjects that underwent PV isolation for paroxysmal or non-longstanding persistent AF and are free of arrhythmia at the end of the 3-month blanking period while taking ADT. Eligible subjects who sign the study informed consent form will be randomized into one of two study arms:
PVI+ADT Group: continue ADT through 9 months follow-up PVI-ADT Group: no ADT through 9 months follow up
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PVI-ADT | Active Comparator | discontinue antiarrhythmic drugs at 3 months post PVI |
|
| PVI+ADT | Active Comparator | discontinue antiarrhythmic drugs at 12 months post PVI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PVI-ADT | Other | Discontinue antiarrhythmic drugs at randomisation (3 months post ablation). As per the eligibility criteria, all patients randomised are taking either Flecainide, Cibenzoline, Propafenon, Sotalol or Amiodarone. These are discontinued at the moment of randomisation in this arm |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy as measured by freedom of arrhythmia recurrence | Arrhythmia recurrence rate at 1 year post ablation (9 months post randomization) | 9 months |
| Safety as measured by drug discontinuation | Number of participants with any adverse events at 1 year post ablation (9 months post randomization) leading to drug discontinuation | 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mattias Duytschaever, MD, PhD | AZ Sint-Lucas Brugge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OLV Hospital | Aalst | 9300 | Belgium | |||
| AZ St Jan |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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|
| PVI+ADT | Other | Discontinue antiarrhythmic drugs 9 months after randomisation (12 months post ablation). As per the eligibility criteria, all patients randomised are taking either Flecainide, Cibenzoline, Propafenon, Sotalol or Amiodarone. These are continued in this arm until 9 months post randomisation at which point they are stopped |
|
| Bruges |
| 8300 |
| Belgium |
| D013568 |
| Pathological Conditions, Signs and Symptoms |