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N/A Completed N=177 Treatment

A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator

Source: ClinicalTrials.gov NCT05971693 ↗
Enrolled (actual)
177
Serious AEs
8.5%
Results posted
Mar 2026
Primary outcomePrimary: Percentage of Participants With Primary Adverse Events (PAEs) — 0; 0; 0; 0 Percentage of participants

Summary

The purpose of this study is to demonstrate safety and effectiveness of the ablation system (OMNYPULSE Bi-directional catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF).

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants With Primary Adverse Events (PAEs)
0; 0; 0; 0; 0; 0
PRIMARY
Percentage of Participants With Acute Effectiveness Success
100; 100
SECONDARY
Percentage of Participants With Freedom From Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia Episodes and Acute Procedural Failure

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with Symptomatic paroxysmal atrial fibrillation (PAF) defined as as atrial fibrillation (AF) that terminates spontaneously or with intervention within 7 days of onset. This PAF is considered to be symptomatic if symptoms related to AF are experienced by the participant
  • Selected for AF ablation procedure by pulmonary vein isolation (PVI)
  • Willing and capable of providing consent
  • Able and willing to comply with all pre-, post- and follow-up testing and requirements

Exclusion Criteria

  • Previously known AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (example, documented obstructive sleep apnea, acute alcohol toxicity, morbid obesity [body mass index greater than {>} 40 kilograms per meter square {kg/m^2}]), renal insufficiency (with an estimated creatinine clearance less than ( 7 days in duration)
  • Severe dilatation of the left atrium (LA) (left anterior descending artery [LAD] >50 millimeter [mm] antero-posterior diameter in case of transthoracic echocardiography [TTE])
  • Presence of LA thrombus
  • Severely compromised left ventricular ejection fraction (left ventricular ejection fraction [LVEF] <40 percentage [%])
  • Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
  • History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
  • History of a documented thromboembolic event (including transient ischemic attack [TIA]) within the past 6 months
  • Previous percutaneous coronary intervention (PCI) / myocardial infarction (MI) within the past 2 months
  • Previous coronary artery bypass grafting (CABG) in conjunction with valvular surgery, cardiac surgery (example, ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure
  • Unstable angina pectoris within the past 6 months
  • Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months
  • Significant pulmonary disease (example, 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
  • Known significant pulmonary vein (PV) anomaly that in the opinion of the investigator would preclude enrollment in this study
  • Prior diagnosis of pulmonary vein stenosis
  • Pre-existing hemi diaphragmatic paralysis
  • Acute illness, active systemic infection, or sepsis
  • Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
  • Severe mitral regurgitation
  • Presence of implanted pacemaker or implantable cardioverter-defibrillator (ICD) or other implanted metal cardiac device that may interfere with the pulsed electric field energy
  • Presence of a condition that precludes vascular access (such as Inferior Vena Cava [IVC] filter)
  • Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this study
  • Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being
  • Current enrollment in an investigational study evaluating another device or drug
  • Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation
  • Life expectancy less than 12 months
  • Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions For Use (IFU)
  • Known contraindication for magnetic resonance imaging (MRI) such as use of contrast agents due to advanced renal disease, claustrophobia etcetra. (at principle investigator [PI] discretion)
  • Presence of iron-containing metal fragments in the body
  • Known unresolved pre-existing neurological deficit
  • Known uncontrolled significant gast
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05971693). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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