Clinical trial NCT03437733: Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.
Official title: Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Keywords: Radiofrequency Ablation
Paroxysmal Atrial Fibrillation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2018-02-19
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Early Onset Primary Adverse Events (PAEs): Death, Atrio-esophageal Fistula and Pulmonary Vein Stenosis
timeFrame: Up to 90 days (post initial mapping and ablation procedure)
measure: Number of Participants With Early Onset PAEs: Myocardial Infraction, Cardiac Tamponade/Perforation, Thromboembolism, Stroke/Cerebrovascular Accident, Transient Ischemic Attack, Phrenic Nerve Paralysis, and Major Vascular Access Complication/Bleeding
timeFrame: Up to 7 days (post initial mapping and ablation procedure)
measure: Percentage of Participants With Acute Procedural Success
timeFrame: Day 1
Secondary outcomes:
measure: Number of Participants With Individual PAE From Primary Composite
timeFrame: Up to 7 days for MI, CT/perforation, thromboembolism, stroke/CVA, TIA, PNP and MVAC (initial mapping and ablation procedure) and up to 90 days for death, AE fistula, and PVST (post procedure)
measure: Number of Participants With Serious Adverse Device Effects (SADEs)
timeFrame: Up to 405 Days
measure: Number of Participants With Serious Non-primary Adverse Events Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and Greater Than or Equal to (>=) 31 Days (Late Onset) of Initial Ablation Procedure
timeFrame: Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 405 Days)
measure: Number of Participants With Non-serious Adverse Events
timeFrame: Up to 405 Days
measure: Number of Participants With Pre-and Post-ablation Asymptomatic and Symptomatic Cerebral Emboli
timeFrame: Pre-procedure, at Discharge, 1 Month and at unscheduled visit (Up to 405 Days)
measure: Number of Participants With Symptomatic and Asymptomatic Cerebral Emboli
timeFrame: Up to 405 Days
measure: Number of Participants With New or Worsening Neurologic Deficits
timeFrame: Pre-procedure, discharge, 1 Month, 3 Month and 6 Month
measure: Number of Participants With NIHSS Scores
timeFrame: Pre-procedure and at discharge (Up to 405 Days)
measure: Number of Participants With MoCA Scores
timeFrame: Up to 405 Days
measure: Number of Participants With Hospitalization for Cardiovascular Events
timeFrame: Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 405 Days)
measure: Percentage of Participants With PVI Touch-up by Balloon and/or Focal Catheter Among All Targeted Veins and by Participants
timeFrame: Up to 405 Days
measure: Percentage of Participants With Use of Focal Catheter Ablation for Non-PV Triggers
timeFrame: Up to 405 Days
measure: Percentage of Participants With Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atypical (Left Side) Atrial Flutter (AFL) Episodes or Documented Symptomatic AF/AT/AFL
timeFrame: Up to 6 Months
measure: Percentage of Participants With Freedom From Documented, AF, AT, or Atypical (Left Side) AFL Episodes or Documented Symptomatic AF/AT/AFL
timeFrame: Up to 12 Months
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Na Homolce Hospital
city: Bari
country: Italy
facility: Ospedale "F. Miulli"
city: Milan
country: Italy
facility: Centro Cardiologico Monzino
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
city: London
country: United Kingdom
facility: Bart's Health NHS Trust
Study officials:
References:
citation: Schilling R, Dhillon GS, Tondo C, Riva S, Grimaldi M, Quadrini F, Neuzil P, Chierchia GB, de Asmundis C, Abdelaal A, Vanderlinden L, Tan T, Ding WY, Gupta D, Reddy VY. Safety, effectiveness, and quality of life following pulmonary vein isolation with a multi-electrode radiofrequency balloon catheter in paroxysmal atrial fibrillation: 1-year outcomes from SHINE. Europace. 2021 Jun 7;23(6):851-860. doi: 10.1093/europace/euaa382.