Performance of QDOT Micro™ Catheter With nGEN Generator for Patients With AFIB.
NCT ID: NCT04545619
Last Updated: 2025-06-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2020-10-02
2021-11-09
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
OTHER
NONE
Study Groups
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Paroxysmal and Early Persistent AFIB
QDOT MICRO System
QDOT Micro Catheter with nGEN Generator
Interventions
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QDOT MICRO System
QDOT Micro Catheter with nGEN Generator
Eligibility Criteria
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Inclusion Criteria
2. Age 18 or older.
3. Signed the Patient Informed Consent Form (ICF).
Exclusion Criteria
2. Presence of a myxoma or an intracardiac thrombus.
3. Presence of prosthetic valves.
4. Presence of active systemic infection
5. Patient with an interatrial baffle or patch
6. 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.
18 Years
ALL
No
Sponsors
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Biosense Webster, Inc.
INDUSTRY
Responsible Party
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Locations
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Institut de Cardiologie de Montréal (Montreal Heart Institute)
Montreal, Quebec, Canada
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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BWI_2019_09
Identifier Type: -
Identifier Source: org_study_id
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