Clinical Study for Workflow and Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System for Treating Symptomatic Paroxysmal AF (QDOT-Micro)

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: THERMOCOOL SMARTTOUCH® SF-5D catheter

• Registration Number: NCT02944968
• Lead Sponsor: Biosense Webster, Inc.

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.

Study Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2016-10-21
• Study First Submitted QC: 2016-10-24
• Study First Posted: 2016-10-26
• Primary Completion: 2018-08-06
• Study Completion: 2018-08-06
• Results First Submitted: 2019-08-05
• Results First Submitted QC: 2019-10-28
• Results First Posted: 2019-11-18
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	THERMOCOOL SMARTTOUCH® SF-5D catheter	Radiofrequency ablation treatment with the THERMOCOOL SMARTTOUCH® SF-5D catheter in Paroxysmal AF population.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Entrance Block Confirmation in the Total Effectiveness Outcome Population	Day of ablation procedure	Confirmation of entrance block in all targeted PVs after adenosine and/or isoproterenol challenge achieved at the end of procedure. If the challenge was not done, confirmation data would not be available.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Early Onset Primary Adverse Events in Total Safety Population	Seven Days Post Procedure	Primary adverse events include Death, Atrio-Esophageal Fistula, Cardiac Tamponade/Perforation, Myocardial Infarction, Stroke/Cerebrovascular Accident, Thromboembolism, Transient Ischemic Attack, Diaphragmatic Paralysis, Pneumothorax, Heart Block, Pulmonary Vein Stenosis, Pulmonary Edema (Respiratory Insufficiency), Vagal Nerve Injury, Pericarditis, Major Vascular Access Complication/Bleeding, Pulmonary vein (PV) stenosis and atrio-esophageal fistula

Trial Locations

Locations (6)

OLV Hospital Aalst; 🇧🇪 Aalst, Belgium

IKEM; 🇨🇿 Prague, Czechia

Na Homolce Hospital; 🇨🇿 Prague, Czechia

Jessa Hospital; 🇧🇪 Hasselt, Belgium

Ospedale Generale Regionale F Miulli; 🇮🇹 Bari, Italy

Skejby _ Aarhus University hospital; 🇩🇰 Aarhus, Denmark