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The goal of this cluster randomization study is to evaluate currently used standard methods for pulse field ablation in patients with irregular heart rhythm also called atrial fibrillation (AF) who are treated at Rigshospitalet and Gentofte Hospital in Copenhagen, Denmark.
A cluster randomization study tests standardized treatments by rotating the treatments over time periods. All patients will be treated with the specific standard treatment of the period and will be informed about the study. The patient will have the option to decline their participatiion in the study in writing and their data will not be collected.
The main purpose of the study is to investigate whether one of more of the systems are more efficient in preventing AF or atrial flutter during the following 12 months. Additionally, the safety of the systems are compared to see if one or more are more efficient in preventing complications 30 days after the ablation procedure.
The patients will receive standard treatment according to the cluster at the time of their ablation and data for up to 12 months post procedure will be collected by medicial chart review.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FARAPULSE and FARAVIEW | Active Comparator | PFA system |
|
| VARIPULSE | Active Comparator | PFA system |
|
| PULSE-SELECT and AFFERA | Active Comparator | PFA system |
|
| Arctic Front Advance Cardiac Cryoablation Catheter | Active Comparator | Ablation system |
|
| VOLT | Active Comparator | PFA system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulse field ablation Systems | Device | Pulse field ablation Systems |
|
| Measure | Description | Time Frame |
|---|---|---|
| Atrial fibrillation or atrial flutter | Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG) | 12 months post procedure |
| Atrial fibrillation or atrial flutter | Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG) | 6 months post procedure |
| Atrial fibrillation or atrial flutter | Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG) | 3 months post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization due to atrial fibrillation or flutter | Hospitalization due to atrial fibrillation or flutter including DC cardioversion | 12 months post procedure |
| Hospitalization due to atrial fibrillation or flutter |
| Measure | Description | Time Frame |
|---|---|---|
| Resources and costs | Total costs of treatment (Hospitalization, DC-conversiton, medication and procedure-related costs) in Euros | 12 month |
Inclusion Criteria:
Exclusion Criteria:
- Opt out of data collection
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter K Jacobsen, MD, DMSc | Contact | 35456752 | Peter.Karl.Jacobsen@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Peter K Jacobsen, MD, PhD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | 2100 | Denmark |
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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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Hospitalization due to atrial fibrillation or flutter including DC cardioversion
| 6 months post procedure |
| Patient reported outcome measures | Patient reported symptoms and quality of life (Questionnaires) | 12 month |
| Patient reported outcomes measures | Patient reported symptoms and quality of life (Questionnaires) | 6 month |
| Patient reported outcomes measures | Patient reported symptoms and quality of life (Questionnaires) | 3 month |
| Antiarrhythmic medications | Use of antiarrhythmic medications | 12 months post procedure |
| Antiarrhythmic medications | Use of antiarrhythmic medications | 6 months post procedure |
| Duration of the procedure | The duration of the ablation procedure | Post procedure |
| Safety of the system | The frequency of procedure-related complications | 30 days post procedure |
| D013568 |
| Pathological Conditions, Signs and Symptoms |