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. (QDOT-FAST)

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

Study Overview

• Status: Completed
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Device: THERMOCOOL SMARTTOUCH SF-5D Catheter

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria
    • Elisabethinen Hospital
• Belgium
  • Aalst, Belgium
    • OLV Aalst
  • Brugge, Belgium
    • AZ Sint-Jan
  • Hasselt, Belgium
    • Jessa Ziekenhuis
• Czechia
  • Ceské Budejovice, Czechia
    • Ceske Budejovice Hospital
  • Prague, Czechia
    • Na Homolce
• Italy
  • Bari, Italy
    • Ospedale F Miulli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment Group; 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).	Device: THERMOCOOL SMARTTOUCH SF-5D Catheter; radiofrequence ablation with THERMOCOOL SMARTTOUCH® SF-5D catheter used in combination with the nMARQ™ Multi-Channel RF Generator with TGA mode

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Achieved Acute Procedural Success	Defined acute procedural success as confirmation of entrance block in all targeted pulmonary veins after adenosine or isoproterenol challenge.	Day 1
Incidence of Acute Safety	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.	7 days post-procedure

Collaborators and Investigators

• Sponsor: Biosense Webster, Inc.

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 2, 2018
• Primary Completion (ACTUAL): October 8, 2018
• Study Completion (ACTUAL): October 8, 2018

Study Registration Dates

• First Submitted: February 23, 2018
• First Submitted That Met QC Criteria: March 2, 2018
• First Posted (ACTUAL): March 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 6, 2019
• Last Update Submitted That Met QC Criteria: October 18, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Interventional; Radiofrequency Ablation; Paroxysmal Atrial Fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: BWI_2017_02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes