Status:
COMPLETED
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.
Lead Sponsor:
Biosense Webster, Inc.
Conditions:
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study.
Detailed Description
The purpose of this study is to evaluate safety and acute performance of the THERMOCOOL SMARTTOUCH® SF-5D catheter used in combination with the nMARQ™ Multi-Channel RF Generator with TGA mode in the t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2018
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03459196
Start Date
April 2 2018
End Date
October 8 2018
Last Update
June 29 2025
Active Locations (7)
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1
Elisabethinen Hospital
Linz, Austria
2
OLV Aalst
Aalst, Belgium
3
AZ Sint-Jan
Bruges, Belgium
4
Jessa Ziekenhuis
Hasselt, Belgium