AzTrials
AzTrials

Atrial Fibrillation ParoxysmalNCT06271967

FOCALFLEX (CE Mark) Study

A study testing TactiFlex™ Ablation Catheter Sensor Enabled™ in people with Atrial Fibrillation Paroxysmal, run by Abbott Medical Devices at 24 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation Paroxysmal
What is being tested?
TactiFlex™ Ablation Catheter Sensor Enabled™
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
24 sitesin 11 countries
Study dates
15 Aug 2024to 19 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented symptomatic paroxysmal AF (PAF). Documentation requirements are as follows:
  • Physician's note indicating recurrent self-terminating AF with ≥ 2 episodes of PAF within the 6 months prior to enrollment AND
  • One electrocardiographically documented PAF episode within 12 months prior to enrollment.
  • 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.

Who cannot join

  • Previously diagnosed persistent or long-standing persistent atrial fibrillation (Continuous AF greater than 1 year in duration)
  • 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
  • Known presence of cardiac thrombus
  • Left atrial diameter (LAD) ≥ 5.5 cm (anteroposterior diameter) within 180 days prior to the index procedure
  • Left ventricular ejection fraction (LVEF) < 35% as assessed with echocardiography or computerized tomography (CT) within 180 days prior to the index procedure
  • New York Heart Association (NYHA) class III or IV heart failure
Show all 36Show fewer
  • Body mass index > 40 kg/m2
  • Pregnant or nursing
  • Patients who have had a ventriculotomy or atriotomy within the preceding 28 days of procedure
  • Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 90 days
  • Stroke or TIA (transient ischemic attack) within the last 90 days
  • Heart disease in which corrective surgery is anticipated within 180 days after procedure
  • History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti-coagulant state
  • Contraindication to long term anti-thromboembolic therapy
  • Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
  • Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication
  • Previous left atrial surgical or left atrial catheter ablation procedure (including left atrial appendage (LAA) closure device)
  • Plans to have an LAA closure device implanted during the follow-up period
  • Presence of any condition that precludes appropriate vascular access
  • Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2).
  • Previous tricuspid or mitral valve replacement or repair
  • Patients with prosthetic valves
  • Patients with a myxoma
  • Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt
  • Stent, constriction, or stenosis in a pulmonary vein
  • Rheumatic heart disease
  • Hypertrophic cardiomyopathy
  • Active systemic infection
  • Renal failure requiring dialysis
  • 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
  • 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.
  • 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
  • Unlikely to survive the protocol follow up period of 12 months
  • 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.
  • Individuals without legal authority
  • Individuals unable to read or write

Trial locations and contacts

24 sites in 11 countries.

24 sites in 11 countries

Australia4 sites

  • Royal Adelaide Hospital

    Adelaide, Saustrl, 5000

  • Peninsula Private Hospital

    Langwarrin, Victoria, 3910

  • Royal Melbourne Hospital - City Campus

    Parkville, Victoria, 3050

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Netherlands4 sites

  • Universitair Medische Centrum Groningen

    Groningen, Grogen, 9713 GZ

  • Leiden University Medical Center

    Leiden, Zuid, 2333 ZA

  • St. Antonius Ziekenhuis

    Nieuwegein, Utrecht, 3435 CM

  • Haga Ziekenhuis Locatie Leyenburg

    The Hague, ZUID, 2545AA

Other trials in Netherlands

France3 sites

  • CHU Trousseau

    Chambray-lès-Tours, Centre-Val de Loire, 37170

  • Hôpital Pitié Salpetrière

    Paris, ILE, 75651

  • Hopital Haut Leveque

    Pessac, Aquitaine, 33604

Other trials in France

Spain3 sites

  • Hospital Ramón y Cajal

    Madrid, Madrid, 28034

  • Clínica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitari i Politècnic La Fe

    Valencia, Valncia, 46026

Other trials in Spain

Austria2 sites

  • Universitätsklinik Graz

    Graz, Styria, 8036

  • A. ö. Krankenhaus der Elisabethinen Linz

    Linz, UPR AUS, 4020

Other trials in Austria

Germany2 sites

  • Herz-und Diabetes Zentrum NRW

    Bad Oeynhausen, N. RHIN, 32545

  • Deutsches Herzzentrum München des Freistaates Bayern

    München, Bavaria, 80636

Other trials in Germany

Italy2 sites

  • Ospedale San Raffaele

    Milan, Lombard, 20132

  • Centro Cardiologico Monzino

    Milan, Lombard, 20138

Other trials in Italy

Belgium1 site

  • UZ Brussel

    Brussels, B CAP R, 1090

Other trials in Belgium

Czechia1 site

  • Nemocnice Ceske Budejovice, a.s.

    České Budějovice, Sbohmia, 37001

Other trials in Czechia

Denmark1 site

  • Skejby University Hospital

    Aarhus, Arhus, 8200

Other trials in Denmark

United Kingdom1 site

  • The Royal Sussex County Hospital

    Brighton, Soeast, BN25BE

Other trials in United Kingdom

About this study

Official title: A Study of FOCAL Pulsed Field Ablation With the TactiFLEX SE Catheter and Volt Generator for the Treatment of Paroxysmal Atrial Fibrillation (FOCALFLEX)

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).

Read the 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.

Being tested
TactiFlex™ Ablation Catheter Sensor Enabled™
Keywords
Pulse Field Ablation, Ablation Catheter, arrhythmia, PFA, Paroxysmal AF
Medical subject headings
Atrial Fibrillation, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TactiFlex™ Ablation Catheter Sensor Enabled™Device

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

Study groups in NCT06271967
Study groupRoleWhat they receive
treatment armExperimentalPatients treated for paroxysmal atrial fibrillation with the TactiFlex™ Ablation Catheter Sensor Enabled™ (SE).
Receives: Device: TactiFlex™ Ablation Catheter Sensor Enabled™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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:

    • Atrio-esophageal fistula
    • Cardiac tamponade/perforation
    • Death
    • Heart block
    • Myocardial infarction
    • Pericarditis
    • Phrenic nerve injury resulting in diaphragmatic paralysis
    • Pulmonary edema
    • Pulmonary vein stenosis
    • Stroke/cerebrovascular accident
    • Thromboembolism
    • Transient ischemic attack
    • Vagal nerve injury/gastroparesis
    • Major Vascular access complications / major bleeding event
    • Device and/or procedure related cardiovascular and/or pulmonary adverse event that prolongs hospitalization for more than 48 hours (excluding hospitalization solely for arrhythmia recurrence or non-urgent cardioversion)

    Measured: 7 days

  2. 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).

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2024
  2. Study start15 Aug 2024
  3. Primary completion9 Jul 2025
  4. Study completion19 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06271967
Sponsor's protocol ID
ABT-CIP-10518
Status last verified
Feb 2026
First submitted
15 Feb 2024
Last updated
5 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 42097576

Questions about this trial

What is this clinical trial studying?

A study testing TactiFlex™ Ablation Catheter Sensor Enabled™ in people with Atrial Fibrillation Paroxysmal, run by Abbott Medical Devices at 24 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Australia, Netherlands, France, Spain, Austria and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of primary safety endpoint events (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06271967, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in