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Atrial Fibrillation (AF)FlexPulse IDENCT06676072

A Study of the TactiFlex SE Catheter and Volt PFA Generator in Subjects With PAF:

A study testing PFA Ablation catheter in people with Atrial Fibrillation (AF) and Atrial Arrhythmia, run by Abbott Medical Devices at 32 sites in 4 countries.

Completed

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

Official record
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Trial summary

The objective of this clinical study is to demonstrate that ablation with the TactiFlex SE Ablation catheter, in conjunction with a compatible pulsed field ablation (PFA) and/or radio frequency (RF) generator, is safe and effective for the treatment of symptomatic, recurrent, drug refractory paroxysmal atrial… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PFA Ablation catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
188 participants
Where
32 sitesin 4 countries
Study dates
22 Nov 2024to 13 Apr 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 atrial fibrillation (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.
  • NOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of continuous AF from another ECG device.
  • Plans to undergo a catheter ablation procedure due to symptomatic PAF 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.

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) > or equal to 5.0 cm (anteroposterior diameter) within 180 days prior to the index procedure
  • Left ventricular ejection fraction (LVEF) < or equal to 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 > or equal to 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

32 sites in 4 countries.

32 sites in 4 countries

United States29 sites

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48104

  • Piedmont Athens Regional Medical Center

    Athens, Georgia, 30606

  • Texas Cardiac Arrhythmia

    Austin, Texas, 78705

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ocelot Medical Research Group

    Dallas, Texas, 75230

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • Medical City Fort Worth

    Fort Worth, Texas, 76104

  • The Heart Rhythm Center of MS

    Gulfport, Mississippi, 39501

  • Bryan Heart Medical Center

    Lincoln, Nebraska, 68506

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211

  • South Denver Cardiology Associates PC

    Littleton, Colorado, 80120

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • HCA Florida Mercy Hospital

    Miami, Florida, 33133

  • Tristar Centennial Medical Center

    Nashville, Tennessee, 37203

  • Vanderbilt Heart & Vascular Institute

    Nashville, Tennessee, 37232

  • NYU Langone Health

    New York, New York, 10016

  • New York Presbyterian Hospital/Cornell University

    New York, New York, 10021

  • AdventHealth Orlando

    Orlando, Florida, 32803

  • Kansas City Cardiac Arrhythmia Research Foundation

    Overland Park, Kansas, 66211

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Virginia Commonwealth University

    Richmond, Virginia, 23219

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • HonorHealth

    Scottsdale, Arizona, 85258

  • The Heart Institute at Virginia Mason

    Seattle, Washington, 98111

  • Houston Methodist The Woodlands Hospital

    Shenandoah, Texas, 77385

  • Henry Ford Providence Southfield Hospital

    Southfield, Michigan, 48075

  • Stanford University Medical Center

    Stanford, California, 94305

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308

Other trials in United States

Austria1 site

  • KH Wiener Neustadt

    Wiener Neustadt, L Austr, 2700

Other trials in Austria

Lithuania1 site

  • Vilnius University Hospital Santariskiu Klinikos

    Vilnius, Dzukija, 08661

Other trials in Lithuania

Netherlands1 site

  • Erasmus Medical Center - Thoraxcenter

    Rotterdam, S Holln, 3015 CE

Other trials in Netherlands

About this study

Official title: Safety and Effectiveness of the TactiFlex SE Catheter and Volt Pulsed Field Ablation (PFA) Generator in Subjects With Paroxysmal Atrial Fibrillation

The objective of this clinical study is to demonstrate that ablation with the TactiFlex SE Ablation catheter, in conjunction with a compatible pulsed field ablation (PFA) and/or radio frequency (RF) generator, is safe and effective for the treatment of symptomatic, recurrent, drug refractory paroxysmal atrial fibrillation (PAF).

Read the detailed description

This is a pre-market, prospective, single-arm, non-randomized, multicenter clinical study to demonstrate safety and effectiveness for the treatment of symptomatic, recurrent, drug-refractory PAF.

Being tested
PFA Ablation catheter
Keywords
Symptomatic, recurrent, drug refractory PAF, Atrial Fibrillation, Paroxysmal AF, Pulsed Field Ablation, Radio Frequency, PFA
Medical subject headings
Atrial Fibrillation, Recurrence

What participants receive

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

  • PFA Ablation catheterDevice

    Deliver RF and/or PF energy using the TactFlex PFA system

Study groups in NCT06676072
Study groupRoleWhat they receive
TactiFlex Ablation catheterExperimentalA single use catheter that is designed to facilitate electrophysiological mapping of the heart chambers and to transmit RF current or PFA therapy to the catheter's flexible tip electrode for intracardiac ablation purposes.
Receives: Device: PFA Ablation catheter

What is being measured

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

  1. Proportion of subjects experiencing a device and/or procedure-related serious adverse event with onset within 7 days of any ablation procedure (index or repeat procedure performed 0-90 days post initial procedure).

    Measured: 7 days

  2. Freedom from documented (symptomatic or asymptomatic) AF/AFL/AT episodes of greater than 30 seconds duration that are documented by protocol-specified 12-lead ECG, TTM or Holter monitor (HM) devices after the index ablation procedure

    Measured: 12 months

Secondary outcomes (2)

  1. Symptomatic Effectiveness

    Freedom from documented symptomatic AF/AF/AT episodes of greater than 30 seconds duration that are documented by protocol-specific 12-lead ECG, TTM or Holter monitor devices after the index ablation procedure.

    Measured: 12 months

  2. AAD-Free Effectiveness

    Freedom from documented (symptomatic or asymptomatic) AF/AFL/AT episodes of > 30 seconds duration that are documented by protocol-specific 12-lead ECG, TTM, or Holter monitor after the index ablation procedure. Any use of Class I or III antiarrythmic drugs after the 90-day blanking period will count as a therapy failure in the analysis

    Measured: 12 months

Timeline

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

  1. First posted6 Nov 2024
  2. Study start22 Nov 2024
  3. Primary completion13 Apr 2026
  4. Study completion13 Apr 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
188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06676072
Sponsor's protocol ID
ABT-CIP-10520
Acronym
FlexPulse IDE
Status last verified
May 2026
First submitted
4 Nov 2024
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing PFA Ablation catheter in people with Atrial Fibrillation (AF) and Atrial Arrhythmia, run by Abbott Medical Devices at 32 sites in 4 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 8 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 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, Austria, Lithuania, Netherlands. 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?

Proportion of subjects experiencing a device and/or procedure-related serious adverse event with onset within 7 days of any ablation procedure (index or repeat procedure performed 0-90 days post initial procedure). (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 NCT06676072.

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 1 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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