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

NCT06676072 | Active Not Recruiting DMC FDA Device

• 1 other identifier: ABT-CIP-10520
• Study Type: interventional
• Target: 188
• Locations: 4 countries
• Sites: 32

Brief 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 fibrillation (PAF).

Conditions

Atrial Fibrillation (AF); Atrial Arrhythmia; Paroxysmal AF; Drug Refractory Paroxysmal Atrial Fibrillation

Keywords

Symptomatic, recurrent, drug refractory PAF; Atrial Fibrillation; Paroxysmal AF; Pulsed Field Ablation; Radio Frequency; PFA

Outcome Measures

Primary Outcomes (2)

• 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).

  7 days

• 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

  12 months

Secondary Outcomes (2)

• Symptomatic Effectiveness

  12 months

• AAD-Free Effectiveness

  12 months

Study Arms (1)

TactiFlex Ablation catheter

EXPERIMENTAL

A 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.

Device: PFA Ablation catheter

Interventions

PFA Ablation catheter DEVICE

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

TactiFlex Ablation catheter

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 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.

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) \> 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
• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (32)

HonorHealth

Scottsdale, Arizona, 85258, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

South Denver Cardiology Associates PC

Littleton, Colorado, 80120, United States

Location

HCA Florida Mercy Hospital

Miami, Florida, 33133, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Tallahassee Research Institute

Tallahassee, Florida, 32308, United States

Location

Piedmont Athens Regional Medical Center

Athens, Georgia, 30606, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Kansas City Cardiac Arrhythmia Research Foundation

Overland Park, Kansas, 66211, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48104, United States

Location

Henry Ford Providence Southfield Hospital

Southfield, Michigan, 48075, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

The Heart Rhythm Center of MS

Gulfport, Mississippi, 39501, United States

Location

Bryan Heart Medical Center

Lincoln, Nebraska, 68506, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

New York Presbyterian Hospital/Cornell University

New York, New York, 10021, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Tristar Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Vanderbilt Heart & Vascular Institute

Nashville, Tennessee, 37232, United States

Location

Texas Cardiac Arrhythmia

Austin, Texas, 78705, United States

Location

Ocelot Medical Research Group

Dallas, Texas, 75230, United States

Location

Medical City Fort Worth

Fort Worth, Texas, 76104, United States

Location

Houston Methodist The Woodlands Hospital

Shenandoah, Texas, 77385, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

The Heart Institute at Virginia Mason

Seattle, Washington, 98111, United States

Location

KH Wiener Neustadt

Wiener Neustadt, L Austr, 2700, Austria

Location

Vilnius University Hospital Santariskiu Klinikos

Vilnius, Dzukija, 08661, Lithuania

Location

Erasmus Medical Center - Thoraxcenter

Rotterdam, S Holln, 3015 CE, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation; Recurrence

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Sarah Kammer

  Abbott Medical Devices

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 6, 2024
• Study Start: November 22, 2024
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (29); NL (1); AU (1); LI (1)