FOCALFLEX (CE Mark) Study

NCT ID: NCT06271967

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-15
• Study Completion Date: 2026-01-19

Brief Summary

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).

Detailed Description

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.

Conditions

Atrial Fibrillation Paroxysmal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment arm

Patients treated for paroxysmal atrial fibrillation with the TactiFlex™ Ablation Catheter Sensor Enabled™ (SE).

Group Type: EXPERIMENTAL

TactiFlex™ Ablation Catheter Sensor Enabled™

Intervention Type: DEVICE

Pulsed field ablation (PFA)/radiofrequency (RF) ablation with the TactiFlex™ Ablation Catheter Sensor Enabled™

Interventions

TactiFlex™ Ablation Catheter Sensor Enabled™

Pulsed field ablation (PFA)/radiofrequency (RF) ablation with the TactiFlex™ Ablation Catheter Sensor Enabled™

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Documented symptomatic paroxysmal AF (PAF). Documentation requirements are as follows:

1. Physician's note indicating recurrent self-terminating AF with ≥ 2 episodes of PAF within the 6 months prior to enrollment AND

2. One electrocardiographically documented PAF episode within 12 months prior to enrollment.

2. Plans to undergo a catheter ablation procedure due to symptomatic PAF

3. At least 18 years of age

4. Able and willing to comply with all trial requirements including pre-procedure, post- procedure, and follow-up testing and requirements

5. 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

1. Previously diagnosed persistent or long-standing persistent atrial fibrillation (Continuous AF greater than 1 year in duration)

2. Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and other major surgical procedures in the preceding 90 days

3. Known presence of cardiac thrombus

4. Left atrial diameter (LAD) ≥ 5.5 cm (anteroposterior diameter) within 180 days prior to the index procedure

5. Left ventricular ejection fraction (LVEF) < 35% as assessed with echocardiography or computerized tomography (CT) within 180 days prior to the index procedure

6. New York Heart Association (NYHA) class III or IV heart failure

7. Body mass index > 40 kg/m2

8. Pregnant or nursing

9. Patients who have had a ventriculotomy or atriotomy within the preceding 28 days of procedure

10. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 90 days

11. Stroke or TIA (transient ischemic attack) within the last 90 days

12. Heart disease in which corrective surgery is anticipated within 180 days after procedure

13. History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti-coagulant state

14. Contraindication to long term anti-thromboembolic therapy

15. Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation

16. Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication

17. Previous left atrial surgical or left atrial catheter ablation procedure (including left atrial appendage (LAA) closure device)

18. Plans to have an LAA closure device implanted during the follow-up period

19. Presence of any condition that precludes appropriate vascular access

20. Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2).

21. Previous tricuspid or mitral valve replacement or repair

22. Patients with prosthetic valves

23. Patients with a myxoma

24. Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt

25. Stent, constriction, or stenosis in a pulmonary vein

26. Rheumatic heart disease

27. Hypertrophic cardiomyopathy

28. Active systemic infection

29. Renal failure requiring dialysis

30. Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms

31. Presence of an implantable therapeutic cardiac device including permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) or planned implant of such a device for any time during the follow-up period. Presence of an implantable loop recorder is acceptable as long as it is removed prior to insertion of the investigational device.

32. Patient is currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this clinical trial without pre-approval from this study Sponsor

33. Unlikely to survive the protocol follow up period of 12 months

34. Presence of other medical, anatomic, comorbid, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.

35. Individuals without legal authority

36. Individuals unable to read or write

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Kammer

Role: STUDY_DIRECTOR

Abbott

Locations

Westmead Hospital

Westmead, New South Wales, Australia

Royal Adelaide Hospital

Adelaide, Saustrl, Australia

Peninsula Private Hospital

Langwarrin, Victoria, Australia

Royal Melbourne Hospital - City Campus

Parkville, Victoria, Australia

Universitätsklinik Graz

Graz, Styria, Austria

A. ö. Krankenhaus der Elisabethinen Linz

Linz, UPR AUS, Austria

UZ Brussel

Brussels, B CAP R, Belgium

Nemocnice Ceske Budejovice, a.s.

České Budějovice, Sbohmia, Czechia

Skejby University Hospital

Aarhus, Arhus, Denmark

Hopital Haut Leveque

Pessac, Aquitaine, France

CHU Trousseau

Chambray-lès-Tours, Centre-Val de Loire, France

Hôpital Pitié Salpetrière

Paris, ILE, France

Deutsches Herzzentrum München des Freistaates Bayern

München, Bavaria, Germany

Herz-und Diabetes Zentrum NRW

Bad Oeynhausen, N. RHIN, Germany

Ospedale San Raffaele

Milan, Lombard, Italy

Centro Cardiologico Monzino

Milan, Lombard, Italy

Universitair Medische Centrum Groningen

Groningen, Grogen, Netherlands

St. Antonius Ziekenhuis

Nieuwegein, Utrecht, Netherlands

Leiden University Medical Center

Leiden, Zuid, Netherlands

Haga Ziekenhuis Locatie Leyenburg

The Hague, ZUID, Netherlands

Hospital Ramón y Cajal

Madrid, Madrid, Spain

Clínica Universidad de Navarra

Pamplona, Navarre, Spain

Hospital Universitari i Politècnic La Fe

Valencia, Valncia, Spain

The Royal Sussex County Hospital

Brighton, Soeast, United Kingdom

Countries

Australia; Austria; Belgium; Czechia; Denmark; France; Germany; Italy; Netherlands; Spain; United Kingdom

Other Identifiers

ABT-CIP-10518

Identifier Type: -

Identifier Source: org_study_id