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This study is designed to obtain real-world clinical evidence on the safety and effectiveness of the Volt PFA System in various use cases, with a sub study designed to address additional clinical evidence needs in electrophysiology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Volt PFA Catheter Sensor Enabled (SE) | Other | Patients diagnosed with drug refractory, symptomatic, recurrent, paroxysmal and persistent atrial fibrillation that will undergo a de novo ablation procedure with the Volt PFA Catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed Field Ablation | Device | Pulsed Field Ablation using the Volt PFA System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of subjects experiencing a device and/or procedure-related serious adverse event with onset within 7 days of any ablation procedure that uses Volt AF | Serious adverse events are defined as:
| 7 days |
| Long-term Effectiveness will be the proportion of subjects with freedom from documented AF/AFL/AT recurrence through 12-months. | Other situations in which subjects will be considered effectiveness endpoint failures include:
| During procedure |
| Acute procedural effectiveness is defined as confirmation of entrance block in all targeted pulmonary veins | A secondary measure of confirmation to include any one of the following (the same method must be used for all pulmonary veins) :
| During procedure |
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Inclusion Criteria:
Documented symptomatic PAF or PersAF. Documentation requirements are as follows:
Paroxysmal:
Persistent: Continuous AF sustained beyond 7 days and less than 1 year that is documented by
Physician's note, AND either
24-hour Holter within 360 days prior to enrollment, showing continuous AF, OR
Two electrocardiograms (from any form of rhythm monitoring) showing continuous AF:
NOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of AF from another ECG device.
Plans to undergo a de novo ablation procedure with the Volt PFA Catheter due to symptomatic PAF or PersAF and is refractory, intolerant, or contraindicated to at least one Class I-IV AAD medication
At least 18 years of age
Able and willing to comply with all trial requirements including pre-procedure, post- procedure, and follow-up testing and requirements
Informed of the nature of the trial, agreed to its provisions, and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical trial site.
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karolilen Timmermans | Contact | +3222006511 | karolien.timmermans@abbott.com | |
| Christine Sasaridis | Contact | christine.sasaridis@abbott.com |
| Name | Affiliation | Role |
|---|---|---|
| Sarah C Kammer | Abbott Medical Devices | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ordensklinikum Linz Elisabethinen | Recruiting | Linz | 4020 | Austria |
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| AZ Sint Jan | Recruiting | Bruges | 8000 | Belgium |
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| UZ Brussel | Recruiting | Brussels | 1090 | Belgium |
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| Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
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| Hôpital Pitié Salpetrière | Recruiting | Paris | 75013 | France |
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| Hopital Haut Leveque | Recruiting | Pessac | 33600 | France |
|
| Clinique Pasteur Toulouse | Recruiting | Toulouse | 31076 | France |
|
| Herz-und Diabetes Zentrum NRW | Recruiting | Bad Oeynhausen | 32545 | Germany |
|
| Medizinische Einrichtungen der Universität zu Köln | Recruiting | Cologne | 50937 | Germany |
|
| Asklepios Klinik St. Georg | Recruiting | Hamburg | 20099 | Germany |
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| TUM Klinikum - Deutsches Herzzentrum München | Recruiting | München | 80636 | Germany |
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| Mater Private Hospital | Recruiting | Dublin | DUBLIN 7 | Ireland |
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| Az. Osp.Universitaria Osp.Riuniti Umberto I-Lancisi-Salesi | Recruiting | Ancona | 60126 | Italy |
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| Centro Cardiologico Monzino | Recruiting | Milan | 20138 | Italy |
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| Universitair Medisch Centrum Groningen | Not yet recruiting | Groningen | 9713 GZ | Netherlands |
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| St. Antonius Ziekenhuis | Recruiting | Nieuwegein | 3435 CM | Netherlands |
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| National Institute of Cardiology Warsaw | Recruiting | Warsaw | 04-628 | Poland |
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| ULS de Lisboa Ocidental | Recruiting | Lisbon | 2799-523 | Portugal |
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| Hospital Universitario A Coruña | Recruiting | A Coruña | 15006 | Spain |
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| Hospital Universitario Doce de Octubre | Recruiting | Madrid | 28041 | Spain |
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| Hospital Universitari i Politècnic La Fe | Recruiting | Valencia | 46026 | Spain |
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| Karolinska University Hospital Huddinge | Recruiting | Stockholm | 14186 | Sweden |
|
| 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 |
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