Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is designed to determine the best practices in the patient pathway, and to analyze pre-procedural, procedural and follow-up workflow data related with ablation of atrial fibrillation where the FARAPULSE™ Pulsed Field Ablation System is used in a commercial and standard of care setting. Workflow-related variables, inclusive of pre-procedural imaging, methods of transseptal access, anesthesia/sedation technique, intracardiac mapping, ablation settings, dosing strategy, lesion sets and general procedure management, will be used to identify predominant workflow schemes that will be associated with patient demographics, procedure-related complications (safety parameters), and one-year effectiveness parameters.
The study data can be used for procedural workflow optimization when using Pulsed Field Ablation for the ablation treatment of Atrial Fibrillation based on patient demographics, cardiac anatomy and arrhythmia characteristics.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Association of patient demographics with Index procedure Workflow-related variables | Patient demographics such as age (years), gender, BMI (kg/m²), different comorbidities, LA Volume (ml), PV anatomy, AF type, pre-procedural AF management) will be compared with different index procedure workflow related variables such as pre-procedural imaging, method and location of transseptal access, intracardiac electro-anatomical mapping, imaging techniques, anesthesia/sedation technique, ablation settings, dosing strategy, lesion sets and general procedure management | Index Procedure |
| Association of safety parameters with Index procedure Workflow-related variables | Safety parameters such as device or procedure related serious adverse events (within 7 days onset date) Death; Myocardial Infarction; Stroke; TIA; Peripheral or Organ Thromboembolism; Pulmonary Edema; Unresolved Phrenic Nerve Palsy/Paresis at 12 Months post-Index Procedure; Vascular Access Complications; Heart Block; Gastric Motility / Pyloric Spasm Disorders, Cardiac Tamponade / Perforation; Pericarditis; Severe Hemolysis with Subsequent Renal Injury or Significant Anemia / Within 12 Months onset date: Pulmonary Vein Stenosis; Atrio-Esophageal Fistula) will be compared with different index procedure workflow related variables such as pre-procedural imaging, method and location of transseptal access, intracardiac electro-anatomical mapping, imaging techniques, anesthesia/sedation technique, ablation settings, dosing strategy, lesion sets and general procedure management | 12 months |
| Association of effectiveness parameters with Index procedure Workflow-related variables | Acute and long-term (freedom from AF episodes and freedom from intervention for AF/AFL/AT) Effectiveness parameters will be compared with different index procedure workflow related variables such as pre-procedural imaging, method and location of transseptal access, intracardiac electro-anatomical mapping, imaging techniques, anesthesia/sedation technique, ablation settings, dosing strategy, lesion sets and general procedure management | 12 months |
| Association of patient demographics with effectiveness parameters |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
• Subjects who will undergo an ablation procedure with the FARAPULSE™ Pulsed Field Ablation system, per physician's medical judgement, and according to hospitals' standard of care.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.o. Krankenhaus der Elisabethinen Linz | Linz | Austria | ||||
| Ziekenhuis aan de Stroom, Middelheim |
Not provided
Not provided
Not provided
Patient demographics such as age (years), gender, BMI (kg/m²), different comorbidities, LA Volume (ml), PV anatomy, AF type, pre-procedural AF management) will be compared with Acute and long-term (freedom from AF episodes and freedom from intervention for AF/AFL/AT) Effectiveness parameters |
| 12 months |
| Association of patient demographics with safety parameters | Patient demographics such as age (years), gender, BMI (kg/m²), different comorbidities, LA Volume (ml), PV anatomy, AF type, pre-procedural AF management) will be compared with Safety parameters such as device or procedure related serious adverse events (within 7 days onset date) Death; Myocardial Infarction; Stroke; TIA; Peripheral or Organ Thromboembolism; Pulmonary Edema; Unresolved Phrenic Nerve Palsy/Paresis at 12 Months post-Index Procedure; Vascular Access Complications; Heart Block; Gastric Motility / Pyloric Spasm Disorders, Cardiac Tamponade / Perforation; Pericarditis; Severe Hemolysis with Subsequent Renal Injury or Significant Anemia / Within 12 Months onset date: Pulmonary Vein Stenosis; Atrio-Esophageal Fistula) | 12 months |
| Antwerp |
| Belgium |
| Ziekenhuis Oost-Limburg | Genk | Belgium |
| CHR de la Citadelle | Namur | Belgium |
| CHU de Bordeaux | Bordeaux | France |
| Hopital Saint Philibert | Lomme | France |
| CHRU Hopital Trousseau | Tours | France |
| Universitaetsklinikum Dusseldorf | Düsseldorf | Germany |
| Staedtisches Klinikum Karlsruhe | Karlsruhe | Germany |
| Munchen Klinik Bogenhausen | München | Germany |
| Ippokrateio General Hospital of Athens | Athens | Greece |
| Mitera Hospital | Athens | Greece |
| Azienda Ospedaliero-Universitaria di Ferrara | Ferrara | Italy |
| Ospedale Dell Angelo | Mestre | Italy |
| Azienda Ospedaliera San Gerardo | Monza | Italy |
| Ospedale di Rivoli | Rivoli | Italy |
| Ospedale San Bortolo di Vicenza Azienda ULSS 8 Berica | Vicenza | Italy |
| King Fahd Armed Forces Hospital | Jeddah | Saudi Arabia |
| Hospital De La Santa Creu I Sant Pau | Barcelona | Spain |
| University Hospital Virgen Arrixaca | El Palmar | Spain |
| Hospital de Navarra | Pamplona | Spain |
| Hospital Universitario Nuestra Senora de Candelaria | Santa Cruz de Tenerife | Spain |
| GHP Arytmi Center Stockholm | Stockholm | Sweden |
| Royal Bournemouth Hospital | Bournemouth | United Kingdom |
| Papworth Hospital | Cambridge | United Kingdom |
| Glenfield Hospital | Leicester | United Kingdom |
| Freeman Hospital | Newcastle upon Tyne | United Kingdom |
| Southampton University Hospital | Southampton | United Kingdom |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided