FOCALFLEX (CE Mark) Study

NCT06271967 | Completed DMC FDA Device

• 1 other identifier: ABT-CIP-10518
• Study Type: interventional
• Target: 150
• Locations: 10 countries
• Sites: 22

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).

Conditions

Atrial Fibrillation Paroxysmal

Keywords

Pulse Field Ablation; Ablation Catheter; arrhythmia; PFA; Paroxysmal AF

Outcome Measures

Primary Outcomes (2)

• 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)

  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

Study Arms (1)

treatment arm

EXPERIMENTAL

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

Device: TactiFlex™ Ablation Catheter Sensor Enabled™

Interventions

TactiFlex™ Ablation Catheter Sensor Enabled™ DEVICE

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

treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (24)

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Royal Adelaide Hospital

Adelaide, Saustrl, 5000, Australia

Location

Peninsula Private Hospital

Langwarrin, Victoria, 3910, Australia

Location

Royal Melbourne Hospital - City Campus

Parkville, Victoria, 3050, Australia

Location

Universitätsklinik Graz

Graz, Styria, 8036, Austria

Location

A. ö. Krankenhaus der Elisabethinen Linz

Linz, UPR AUS, 4020, Austria

Location

UZ Brussel

Brussels, B CAP R, 1090, Belgium

Location

Nemocnice Ceske Budejovice, a.s.

České Budějovice, Sbohmia, 37001, Czechia

Location

Skejby University Hospital

Aarhus, Arhus, 8200, Denmark

Location

Hopital Haut Leveque

Pessac, Aquitaine, 33604, France

Location

CHU Trousseau

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

Location

Hôpital Pitié Salpetrière

Paris, ILE, 75651, France

Location

Deutsches Herzzentrum München des Freistaates Bayern

München, Bavaria, 80636, Germany

Location

Herz-und Diabetes Zentrum NRW

Bad Oeynhausen, N. RHIN, 32545, Germany

Location

Ospedale San Raffaele

Milan, Lombard, 20132, Italy

Location

Centro Cardiologico Monzino

Milan, Lombard, 20138, Italy

Location

Universitair Medische Centrum Groningen

Groningen, Grogen, 9713 GZ, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, Utrecht, 3435 CM, Netherlands

Location

Leiden University Medical Center

Leiden, Zuid, 2333 ZA, Netherlands

Location

Haga Ziekenhuis Locatie Leyenburg

The Hague, ZUID, 2545AA, Netherlands

Location

Hospital Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitari i Politècnic La Fe

Valencia, Valncia, 46026, Spain

Location

The Royal Sussex County Hospital

Brighton, Soeast, BN25BE, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarah Kammer

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: August 15, 2024
• Primary Completion: July 9, 2025
• Study Completion: January 19, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); ES (3); GB (1); FR (3); NL (4); AU (4); BE (1); DK (1); DE (2); IT (2)