Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins. (SHINE)

Biosense Webster

Status: Completed

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Device: Radiofrequency Ablation

Study type: Interventional

Funder types: Industry

Identifiers

NCT03437733

BWI_2017_01

Details and patient eligibility

About

This clinical investigation is a prospective, multicenter, single arm clinical evaluation utilizing the multi-electrode radiofrequency balloon catheter and the multi-electrode circular diagnostic catheter.

Full description

The objective of this clinical investigation is to assess the safety and acute effectiveness of the multi-electrode radiofrequency balloon catheter and multi-electrode circular diagnostic catheter when used for the isolation of the pulmonary veins in the treatment of Paroxysmal Atrial Fibrillation (PAF).

Enrollment: 98 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosed with Symptomatic Paroxysmal AF.
2. Selected for atrial fibrillation (AF) ablation procedure for pulmonary vein isolation.
3. Able and willing to comply with uninterrupted per-protocol anticoagulation requirements
4. Age 18-75 years.
5. Able and willing to comply with all pre-, post- and follow-up testing and requirements.
6. Signed Patient Informed Consent Form.

Exclusion criteria

1. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.

2. Previous surgical or catheter ablation for AF.

3. Anticipated to receive ablation outside the PV ostia and Cavo-triscuspid-isthmus (CTI) region

4. Previously diagnosed with persistent, longstanding AF and/or continuous AF > 7 days, or > 48 hrs terminated by cardioversion.

5. Any percutaneous coronary intervention (PCI) within the past 2 months.

6. Valve repair or replacement and presence of a prosthetic valve.

7. Any carotid stenting or endarterectomy.

8. Coronary artery bypass grafting (CABG), cardiac surgery (e.g. ventriculotomy, atriotomy), or valvular cardiac surgical or percutaneous procedure within the past 6 months.

9. Documented left atrium (LA) thrombus on baseline/pre-procedure imaging.

10. LA antero posterior diameter > 50 mm

11. Any PV with a diameter ≥ 26 mm

12. Left Ventricular Ejection Fraction (LVEF) < 40%.

13. Contraindication to anticoagulation (e.g. heparin).

14. History of blood clotting or bleeding abnormalities.

15. Myocardial infarction within the past 2 months.

16. Documented thromboembolic event [including transient ischemic attack(TIA)] within the past 12 months.

17. Rheumatic Heart Disease.

18. Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV.

19. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.

20. Unstable angina.

21. Acute illness or active systemic infection or sepsis.

22. Diagnosed atrial myxoma or interatrial baffle or patch.

23. Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD).

24. Significant pulmonary disease, (e.g. 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.

25. Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study.

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. Enrollment in an investigational study evaluating another device, biologic, or drug.

28. Has known pulmonary vein stenosis.

29. Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter.

30. Presence of an Inferior Vena Cava (IVC) filter

31. Presence of a condition that precludes vascular access.

32. Life expectancy or other disease processes likely to limit survival to less than 12 months.

33. Presenting contra-indication for the devices (e.g. transthoracic echocardiography (TTE), CT, etc.) used in the study, as indicated in the respective instructions for use.

34. Categorized as a vulnerable population and requires special treatment with respect to safeguards of well-being

    Additional exclusion criteria for Neurological Assessment Evaluable (NAE) subjects:

35. Contraindication to use of contrast agents for MRI such as advanced renal disease, etc. (at PI discretion)

36. Presence of iron-containing metal fragments in the body

37. Unresolved pre-existing neurological deficit.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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98 participants in 1 patient group

Intervention

Experimental group

Description:

Ablation with Multi-electrode Radiofrequency (RF) Balloon Catheter

Treatment:

Device: Radiofrequency Ablation