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This clinical investigation is intended to demonstrate safety and effectiveness of the TactiFlex™ Ablation Catheter Sensor Enabled™, the Volt™ Pulse Field Ablation (PFA) Generator, and EnSite™ X EP System with EnSite™ Pulsed Field Ablation Software for the treatment of symptomatic, recurrent paroxysmal atrial fibrillation (PAF).
This is a pre-market, prospective, single-arm, non-randomized, multicenter clinical investigation. Up to 150 subjects will be enrolled in this clinical investigation at up to 25 investigational sites worldwide. The clinical investigation is sponsored by Abbott.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment arm | Experimental | Patients treated for paroxysmal atrial fibrillation with the TactiFlex™ Ablation Catheter Sensor Enabled™ (SE). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TactiFlex™ Ablation Catheter Sensor Enabled™ | Device | Pulsed field ablation (PFA)/radiofrequency (RF) ablation with the TactiFlex™ Ablation Catheter Sensor Enabled™ |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of primary safety endpoint events | The primary safety endpoint is the proportion of subjects experiencing a device and/or procedure-related serious adverse event (SAE) with onset within 7 days of any ablation procedure (index or repeat procedure performed 0-90 days post initial procedure) that uses the TactiFlex PFA System defined below:
| 7 days |
| Freedom from documented AF/AFL/AT recurrence | The primary effectiveness endpoint for this clinical trial is freedom from documented (symptomatic or asymptomatic) AF/AFL/AT episodes of >30 seconds duration that are documented by protocol-specified 12-lead ECG, TTM or Holter monitor (HM) devices after the index ablation procedure through 6 months of follow-up (after a 90-day blanking period following the index ablation procedure). | 6 months |
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Inclusion Criteria:
Documented symptomatic paroxysmal AF (PAF). Documentation requirements are as follows:
Plans to undergo a catheter ablation procedure due to symptomatic PAF
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 | Affiliation | Role |
|---|---|---|
| Sarah Kammer | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia | ||
| Royal Adelaide Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42097576 | Derived | Manninger M, Scherr D, Bulava A, Kalman J, Sanders P, Della Bella P, Martinek MR, Deisenhofer I, Wijnmaalen AP, Osca J, Bolao IG, Moreno J, Jais P, Kronborg MB, Gandjbakhch E, Purerfellner H, Muldoon S, Dirckx N, Woods V, Silberbauer J. Safety and effectiveness of the TactiFlex duo system: 6-month results of the FOCALFLEX study. Europace. 2026 May 6;28(5):euag108. doi: 10.1093/europace/euag108. |
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| Adelaide |
| Saustrl |
| 5000 |
| Australia |
| Peninsula Private Hospital | Langwarrin | Victoria | 3910 | Australia |
| Royal Melbourne Hospital - City Campus | Parkville | Victoria | 3050 | Australia |
| Universitätsklinik Graz | Graz | Styria | 8036 | Austria |
| A. ö. Krankenhaus der Elisabethinen Linz | Linz | UPR AUS | 4020 | Austria |
| UZ Brussel | Brussels | B CAP R | 1090 | Belgium |
| Nemocnice Ceske Budejovice, a.s. | České Budějovice | Sbohmia | 37001 | Czechia |
| Skejby University Hospital | Aarhus | Arhus | 8200 | Denmark |
| Hopital Haut Leveque | Pessac | Aquitaine | 33604 | France |
| CHU Trousseau | Chambray-lès-Tours | Centre-Val de Loire | 37170 | France |
| Hôpital Pitié Salpetrière | Paris | ILE | 75651 | France |
| Deutsches Herzzentrum München des Freistaates Bayern | München | Bavaria | 80636 | Germany |
| Herz-und Diabetes Zentrum NRW | Bad Oeynhausen | N. RHIN | 32545 | Germany |
| Ospedale San Raffaele | Milan | Lombard | 20132 | Italy |
| Centro Cardiologico Monzino | Milan | Lombard | 20138 | Italy |
| Universitair Medische Centrum Groningen | Groningen | Grogen | 9713 GZ | Netherlands |
| St. Antonius Ziekenhuis | Nieuwegein | Utrecht | 3435 CM | Netherlands |
| Leiden University Medical Center | Leiden | Zuid | 2333 ZA | Netherlands |
| Haga Ziekenhuis Locatie Leyenburg | The Hague | ZUID | 2545AA | Netherlands |
| Hospital Ramón y Cajal | Madrid | Madrid | 28034 | Spain |
| Clínica Universidad de Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitari i Politècnic La Fe | Valencia | Valncia | 46026 | Spain |
| The Royal Sussex County Hospital | Brighton | Soeast | BN25BE | United Kingdom |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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