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.
- Conditions
- Paroxysmal Atrial Fibrillation
- Interventions
- Device: THERMOCOOL SMARTTOUCH SF-5D Catheter
- Registration Number
- NCT03459196
- Lead Sponsor
- Biosense Webster, Inc.
- 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 treatment of Paroxysmal Atrial Fibrillation (PAF) during standard electrophysiology mapping and RF ablation procedures.
The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Group THERMOCOOL SMARTTOUCH SF-5D Catheter A novel radiofrequency ablation catheter combining microelectrodes, thermocouples, porous tip irrigation and contact force sensing nMARQ Multi-Channel RF Generator with Software including TGA mode (Temperature Guided Ablation).
- Primary Outcome Measures
Name Time Method Number of Subjects Achieved Acute Procedural Success Day 1 Defined acute procedural success as confirmation of entrance block in all targeted pulmonary veins after adenosine or isoproterenol challenge.
Incidence of Acute Safety 7 days post-procedure Defined as the incidence of early-onset predefined primary adverse events within 7 days of the study procedure, including atrio-eophageal fistula, phrenic nerve paralysis , cardiac tamponade/perforation , pulmonary vein stenosis, death, stroke/CVA, major vascular access complication/bleeding , thromboembolism, myocardial infarction, transient ischemic attack. Device or procedure related death, pulmonary vein stenosis and atrio-esophageal fistula that occur beyond 7 days post- procedure were also be deemed primary AEs.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
OLV Aalst
🇧🇪Aalst, Belgium
AZ Sint-Jan
🇧🇪Brugge, Belgium
Ospedale F Miulli
🇮🇹Bari, Italy
Elisabethinen Hospital
🇦🇹Linz, Austria
Jessa Ziekenhuis
🇧🇪Hasselt, Belgium
Ceské Budejovice Hospital
🇨🇿Ceské Budejovice, Czechia
Na Homolce
🇨🇿Prague, Czechia