A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System
NCT ID: NCT07227532
Last Updated: 2025-11-12
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
276 participants
INTERVENTIONAL
2025-10-21
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator
Participants undergoing electrophysiology mapping and pulsed field ablation (PFA) for management of treatment of symptomatic paroxysmal atrial fibrillation (AF) will undergo pulmonary vein (PV) ablation with the VARIPULSE Catheter with a TRUPULSE Generator.
Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator
Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator will be used.
Interventions
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Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator
Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator will be used.
Eligibility Criteria
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Inclusion Criteria
* Refractory, intolerant, or contraindicated to Class I/III antiarrhythmic drugs (AAD)
* Willing and capable of providing consent
* Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Exclusion Criteria
* Previous surgical or catheter ablation for AF
* Significant congenital anomaly or medical problem that in the opinion of the investigator would be a contraindication to catheter ablation for AF
* Current enrollment in an investigational study evaluating another device or drug
* Life expectancy less than 12 months
* Any contraindications as defined in the Protocol
22 Years
ALL
No
Sponsors
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Biosense Webster, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Biosense Webster, Inc. Clinical Trial
Role: STUDY_DIRECTOR
Biosense Webster, Inc.
Locations
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Community Memorial Hospital
Ventura, California, United States
Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano
Plano, Texas, United States
Mercy Hospital
Janesville, Wisconsin, United States
Countries
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Central Contacts
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Other Identifiers
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BWI202405
Identifier Type: OTHER
Identifier Source: secondary_id
BWI202405
Identifier Type: -
Identifier Source: org_study_id