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

Atrial Fibrillation Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02944968
• Other study ID #: MQDT-166
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: August 6, 2018

Study information

• Verified date: November 2019
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 6, 2018
• Est. primary completion date: August 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• THERMOCOOL SMARTTOUCH® SF-5D catheter

Locations

Country	Name	City	State
Belgium	OLV Hospital Aalst	Aalst
Belgium	Jessa Hospital	Hasselt
Czechia	IKEM	Prague
Czechia	Na Homolce Hospital	Prague
Denmark	Skejby _ Aarhus University hospital	Aarhus
Italy	Ospedale Generale Regionale F Miulli	Bari

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Countries where clinical trial is conducted

Belgium,  Czechia,  Denmark,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Entrance Block Confirmation in the Total Effectiveness Outcome Population	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.	Day of ablation procedure
Secondary	Number of Participants With Early Onset Primary Adverse Events in Total Safety Population	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	Seven Days Post Procedure