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N/A Completed N=54 Treatment

Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation.

Source: ClinicalTrials.gov NCT03459196 ↗
Enrolled (actual)
54
Serious AEs
7.7%
Results posted
Nov 2019
Primary outcomePrimary: Number of Subjects Achieved Acute Procedural Success — 52 Participants

Summary

The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Subjects Achieved Acute Procedural Success
52
PRIMARY
Incidence of Acute Safety
2

Eligibility Criteria

Inclusion Criteria

  • Age 18 or older.
  • Signed the Patient Informed Consent Form (ICF).
  • Diagnosed with symptomatic PAF
  • Selected for catheter ablation through pulmonary vein isolation.
  • Able and willing to comply with all pre-, post-, and follow-up testing and requirements (e.g. patient not confined by a court ruling).

Exclusion Criteria

  • Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
  • Previous surgical or catheter ablation for atrial fibrillation.
  • Previously diagnosed with persistent, longstanding AF and/or continuous AF >7 days, or >48 hrs. terminated by cardioversion.
  • Documented Left Atrial thrombus on baseline/pre-procedure imaging.
  • Any carotid stenting or endarterectomy.
  • Left atrial (LA) size >50mm.
  • Left Ventricular ejection fraction (LVEF) <40%.
  • Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV.
  • History of blood clotting or bleeding abnormalities
  • Contraindication to anticoagulation
  • History of a documented thromboembolic event (including transient ischemic attack (TIA)) within the past 12 months.
  • Previous percutaneous coronary intervention (PCI) or myocardial Infarction (MI) within the past 2 months.
  • Coronary artery bypass grafting (CABG) in conjunction with valvular surgery, cardiac surgery (e.g. ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure.
  • Rheumatic Heart Disease
  • Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.
  • Unstable angina.
  • Significant pulmonary disease (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other diseaseor malfunction of the lungs or respiratory system that produces chronic symptoms.
  • Acute illness, active systemic infection, or sepsis.
  • Presence of atrial myxoma, interatrial baffle or patch
  • Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.
  • Presence of a condition that precludes vascular access.
  • Presence of implanted pacemaker or implantable cardioverter-defibrillator (ICD).
  • Presence of IVC filter
  • Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this trial.
  • Currently enrolled in an investigational study evaluating another device, biologic, 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 or other disease processes likely to limit survival to less than 12 months.
  • Presenting contra-indication for the devices used in the study, as indicated in the respective instructions for use.
  • Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being
  • Contraindication to use of contrast agents for MRI such as advanced renal disease, etc. (at PI discretion)
  • Presence of iron-containing metal fragments in the body
  • Unresolved pre-existing neurological deficit.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03459196). 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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