Clinical trial NCT02944968: Clinical Study for Workflow and Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System for Treating Symptomatic Paroxysmal AF (QDOT-Micro)
Official title: Clinical Study for Workflow and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System (the THERMOCOOL SMARTTOUCH® SF-5D Catheter With Temperature Sensing Capabilities and Micro Electrodes and CARTO 3 V 6.0 Technology) in Treatment of Patients With Paroxysmal Atrial Fibrillation (QDOT-Micro)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Interventional
Radiofrequency Ablation
Paroxysmal Atrial Fibrillation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2016-10-26
Enrollment: 51
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-Micro study is a prospective, multi-center, non-randomized, interventional clinical study.

Detailed description: The purpose of this study is to evaluate the workflow and acute performance , during standard electrophysiology mapping and RF ablation procedures, of the THERMOCOOL SMARTTOUCH® SF-5D catheter with temperature sensing capabilities and micro electrodes used in combination with the CARTO® 3 Navigation System with THERMOCOOL SMARTTOUCH® SF-5D-module.

Eligibility criteria: Inclusion Criteria:

Candidates for this study must meet ALL of the following criteria:

1. Age 18 or older
2. Patients who have signed the Patient Informed Consent Form (ICF)
3. Subjects diagnosed with symptomatic documented PAF\* who are candidates for catheter ablation
4. Able and willing to comply with all pre-, post-, and follow-up testing and requirements (eg. Patient not confined by a court ruling)

Exclusion Criteria:

Candidates for this study will be EXCLUDED from the study if ANY of the following conditions apply:

1. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
2. Previous ablation for atrial fibrillation.
3. Previously diagnosed with persistent AF.
4. Documented Left Atrial thrombus
5. Any carotid stenting or endarterectomy
6. LA size \>50mm
7. LVEF \<40%
8. Uncontrolled heart failure or NYHA function class III and IV
9. History of blood clotting or bleeding abnormalities or contraindication to anticoagulation ( heparin, warfarin, or dabigatran)
10. History of a documented thromboembolic event (including TIA) within the past 12 months.
11. Previous PCI/MI within the past 3 months
12. Previous cardiac surgery (e.g CABG) in conjunction with valve surgery or any valvular cardiac surgical/percutaneous procedure (e.g ventriculotomy, atriomy, valve repair or replacement, presence of a prosthetic valve) within the past 6 months.
13. Awaiting cardiac transplantation or other cardiac surgery within the next 6 months.
14. Unstable angina
15. Significant pulmonary disease (eg, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.
16. Acute illness, active systemic infection, or sepsis.
17. Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation.
18. Presence of a condition that precludes vascular access.
19. Presence of implantable cardioverter-defibrillator (ICD)
20. Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this trial.
21. Currently enrolled in an investigational study evaluating another device, biologics, or drug.
22. Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation (as evidenced by pregnancy test if of child bearing potential).
23. Life expectancy less than 12 months.
24. Presenting contra-indication for the devices used in the study, as indicated in the respective instructions for use.

Primary outcomes:
measure: Number of Participants With Entrance Block Confirmation in the Total Effectiveness Outcome Population
timeFrame: Day of ablation procedure
Secondary outcomes:
measure: Number of Participants With Early Onset Primary Adverse Events in Total Safety Population
timeFrame: Seven Days Post Procedure
Other outcomes:
Locations:
Study officials:
References: