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

NCT ID: NCT02944968

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2018-08-06

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

Radiofrequency ablation treatment with the THERMOCOOL SMARTTOUCH® SF-5D catheter in Paroxysmal AF population.

Group Type: EXPERIMENTAL

THERMOCOOL SMARTTOUCH® SF-5D catheter

Intervention Type: DEVICE

Interventions

THERMOCOOL SMARTTOUCH® SF-5D catheter

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MQDT-166

Identifier Type: -

Identifier Source: org_study_id