Clinical trial NCT03459196: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Keywords: Interventional
Radiofrequency Ablation
Paroxysmal Atrial Fibrillation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-08
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age 18 or older.
2. Signed the Patient Informed Consent Form (ICF).
3. Diagnosed with symptomatic PAF
4. Selected for catheter ablation through pulmonary vein isolation.
5. 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:

1. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
2. Previous surgical or catheter ablation for atrial fibrillation.
3. Previously diagnosed with persistent, longstanding AF and/or continuous AF \>7 days, or \>48 hrs. terminated by cardioversion.
4. Documented Left Atrial thrombus on baseline/pre-procedure imaging.
5. Any carotid stenting or endarterectomy.
6. Left atrial (LA) size \>50mm.
7. Left Ventricular ejection fraction (LVEF) \<40%.
8. Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV.
9. History of blood clotting or bleeding abnormalities
10. Contraindication to anticoagulation
11. History of a documented thromboembolic event (including transient ischemic attack (TIA)) within the past 12 months.
12. Previous percutaneous coronary intervention (PCI) or myocardial Infarction (MI) within the past 2 months.
13. Coronary artery bypass grafting (CABG) in conjunction with valvular surgery, cardiac surgery (e.g. ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure.
14. Rheumatic Heart Disease
15. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.
16. Unstable angina.
17. 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.
18. Acute illness, active systemic infection, or sepsis.
19. Presence of atrial myxoma, interatrial baffle or patch
20. Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.
21. Presence of a condition that precludes vascular access.
22. Presence of implanted pacemaker or implantable cardioverter-defibrillator (ICD).
23. Presence of IVC filter
24. Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this trial.
25. Currently enrolled in an investigational study evaluating another device, biologic, or drug.
26. 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.
27. Life expectancy or other disease processes likely to limit survival to less than 12 months.
28. Presenting contra-indication for the devices used in the study, as indicated in the respective instructions for use.
29. Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being
30. Contraindication to use of contrast agents for MRI such as advanced renal disease, etc. (at PI discretion)
31. Presence of iron-containing metal fragments in the body
32. Unresolved pre-existing neurological deficit.

Primary outcomes:
measure: Number of Subjects Achieved Acute Procedural Success
timeFrame: Day 1
measure: Incidence of Acute Safety
timeFrame: 7 days post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Elisabethinen Hospital
city: Aalst
country: Belgium
facility: OLV Aalst
city: Brugge
country: Belgium
facility: AZ Sint-Jan
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Ceské Budejovice
country: Czechia
facility: Ceské Budejovice Hospital
city: Prague
country: Czechia
facility: Na Homolce
city: Bari
country: Italy
facility: Ospedale F Miulli
Study officials:
References:
citation: Reddy VY, Grimaldi M, De Potter T, Vijgen JM, Bulava A, Duytschaever MF, Martinek M, Natale A, Knecht S, Neuzil P, Purerfellner H. Pulmonary Vein Isolation With Very High Power, Short Duration, Temperature-Controlled Lesions: The QDOT-FAST Trial. JACC Clin Electrophysiol. 2019 Jul;5(7):778-786. doi: 10.1016/j.jacep.2019.04.009. Epub 2019 May 8.