Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2024-06-28
2029-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cryoablation
Subjects undergoing cardiac ablation procedure with the Boston Scientific Cardiac Cryoablation System.
Boston Scientific Cardiac Cryoablation System
The Boston Scientific Cardiac Cryoablation System is intended for ablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI) in the ablation treatment of patients with paroxysmal atrial fibrillation (PAF).The main devices and components of the system consists of the following:
* POLARx™ or POLARx™ FIT Cryoablation Catheter
* POLARMAP™ Catheter
* POLARSHEATH™
* SMARTFREEZE™ Console
* Diaphragm Movement Sensor (DMS)
* Related Accessories
Interventions
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Boston Scientific Cardiac Cryoablation System
The Boston Scientific Cardiac Cryoablation System is intended for ablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI) in the ablation treatment of patients with paroxysmal atrial fibrillation (PAF).The main devices and components of the system consists of the following:
* POLARx™ or POLARx™ FIT Cryoablation Catheter
* POLARMAP™ Catheter
* POLARSHEATH™
* SMARTFREEZE™ Console
* Diaphragm Movement Sensor (DMS)
* Related Accessories
Eligibility Criteria
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Inclusion Criteria
* Subjects who are willing and capable of providing informed consent;
* Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center;
Exclusion Criteria
* Any prior LA ablation;
* Known or pre-existing severe PV Stenosis;
* Subjects with severe valvular disease OR with a prosthetic - mechanical or biological - heart valve (not including valve repair and annular rings);
* Presence of any pulmonary vein stents;
* Subjects with active systemic infection;
* Subject is unable or not willing to complete follow-up visits and examination for the duration of the study;- Subjects with life expectancy ≤ 1 year per investigator's medical judgement;
* Women of childbearing potential who are, or plan to become, pregnant during the time of the study (assessment per investigator's discretion);
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Wilber W Su, MD,FACC,FHRS
Role: STUDY_CHAIR
Banner- University Medical Group- Heart Center, Phoenix, AZ, USA
Locations
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Mercy Gilbert Medical Center
Gilbert, Arizona, United States
Banner University Medical Center Phoenix
Phoenix, Arizona, United States
Pima Heart & Vascular Clinical Research
Tucson, Arizona, United States
Torrance Memorial Medical Center
Torrance, California, United States
Intermountain Platte Valley Hospital
Brighton, Colorado, United States
Valley View Hospital
Glenwood Springs, Colorado, United States
St. Joseph's Hospital/BayCare Medical Group
Tampa, Florida, United States
Bethesda North Hospital
Cincinnati, Ohio, United States
Prisma Health Richland Hospital
Columbia, South Carolina, United States
University of Texas Medical Branch - Galveston
Galveston, Texas, United States
Aurora Health
Grafton, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Jacqueline Killian
Role: primary
Jaquelina Patti
Role: primary
Kim Williams
Role: primary
Adeteju Mowo-Wale
Role: primary
Lindsey Allen
Role: primary
Elizabeth Hennesey
Role: backup
Anthony Chambers
Role: primary
Mohamed Djelmami-Hani, MD
Role: backup
Other Identifiers
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PY008
Identifier Type: -
Identifier Source: org_study_id