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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03437733
Recruitment Status : Completed
First Posted : February 19, 2018
Results First Posted : February 10, 2020
Last Update Posted : February 10, 2020
Information provided by (Responsible Party):
Biosense Webster, Inc.

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.

Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Device: Radiofrequency Ablation Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.
Actual Study Start Date : February 28, 2018
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : October 17, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Intervention
Ablation with Multi-electrode Radiofrequency (RF) Balloon Catheter
Device: Radiofrequency Ablation
RF ablation using multi-electrode radiofrequency balloon catheter and multi-electrode circular diagnostic catheter

Primary Outcome Measures :
  1. Number of Participants With Early Onset Primary Adverse Events (PAEs) [ Time Frame: Up to 7 days (post initial mapping and ablation procedure) ]
    PAEs included death, stroke/cerebrovascular accident or stroke (CVA), atrio-esophageal fistula, transient ischemic attack (TIA), myocardial infarction, phrenic nerve paralysis, cardiac tamponade/perforation, pulmonary vein stenosis, thromboembolism, major vascular access complication/bleeding.

  2. Percentage of Participants With Acute Procedural Success [ Time Frame: Day 1 ]
    Acute procedural success is defined as confirmation of entrance block in treated pulmonary veins (PV) after adenosine and/or isoproterenol challenge (with or without the use of a focal catheter).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03437733

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Na Homolce Hospital
Prague, Czechia
Ospedale "F. Miulli"
Bari, Italy
Centro Cardiologico Monzino
Milan, Italy
United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom
Bart's Health NHS Trust
London, United Kingdom
Sponsors and Collaborators
Biosense Webster, Inc.
  Study Documents (Full-Text)

Documents provided by Biosense Webster, Inc.:
Study Protocol  [PDF] July 20, 2018
Statistical Analysis Plan  [PDF] October 2, 2018

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Responsible Party: Biosense Webster, Inc. Identifier: NCT03437733    
Other Study ID Numbers: BWI_2017_01
First Posted: February 19, 2018    Key Record Dates
Results First Posted: February 10, 2020
Last Update Posted: February 10, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Biosense Webster, Inc.:
Radiofrequency Ablation
Paroxysmal Atrial Fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes