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.

Paroxysmal Atrial Fibrillation Clinical Trial

— QDOT-FAST  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03459196
• Other study ID #: BWI_2017_02
• Status: Completed
• Phase: N/A
• Start date: April 2, 2018
• Est. completion date: October 8, 2018

Study information

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

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 8, 2018
• Est. primary completion date: October 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Austria	Elisabethinen Hospital	Linz
Belgium	OLV Aalst	Aalst
Belgium	AZ Sint-Jan	Brugge
Belgium	Jessa Ziekenhuis	Hasselt
Czechia	Ceské Budejovice Hospital	Ceské Budejovice
Czechia	Na Homolce	Prague
Italy	Ospedale F Miulli	Bari

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Countries where clinical trial is conducted

Austria,  Belgium,  Czechia,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

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