Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
Summary
- Conditions
- Paroxysmal Atrial Fibrillation
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Prospective, non-randomized, pre-market clinical evaluation of the QDOT MICRO™ Catheter to demonstrate the safety and effectiveness when compared to an historical control performance goal. the trial has two arms: main arm and second arm (variable flow). The main arm will enroll 185 subjects and seco...
Prospective, non-randomized, pre-market clinical evaluation of the QDOT MICRO™ Catheter to demonstrate the safety and effectiveness when compared to an historical control performance goal. the trial has two arms: main arm and second arm (variable flow). The main arm will enroll 185 subjects and second arm will enroll 92 subjects.
Tracking Information
- NCT #
- NCT03775512
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Emile Daoud Ohio State University Principal Investigator: Jose Osorio Grandview Medical Center Principal Investigator: Francis Marchlinksi University of Pennsylvania Health System Principal Investigator: Michael Cutler Intermountain Medical Center Principal Investigator: Andrea Natale Texas Cardiac Arrhythmia Research Foundation Principal Investigator: Daniel Melby Abbott Northwestern Principal Investigator: Miguel Valderabanno Houston Methodist Principal Investigator: George Monir AdventHealth Principal Investigator: Craig Delaughter Texas Heart Health and Vascular Principal Investigator: Christopher Liu New York Presbyterian Hospital Principal Investigator: Saumil Oza Ascension St. Vincent's Principal Investigator: Ayman Hussein The Cleveland Clinic Principal Investigator: Robert Fishel JFK Hospital Principal Investigator: Kenneth Ellenbogen VCU Principal Investigator: Gery Tomassoni Baptist Hospital Principal Investigator: Tristram Bahnson Duke University Principal Investigator: Chris Ellis VUMC Principal Investigator: Emerson Liu Allegheny College Principal Investigator: David Wilber Loyola University Principal Investigator: Moussa Mansour Mass. General Hospital Principal Investigator: Srinivas Dukkipati Icahn School of Medicine at Mount Sinai Principal Investigator: Hugh McElderry University of Alabama at Birmingham Principal Investigator: Patrick Hranitzky Wakemed Heart and Vascular Principal Investigator: Larry Chinitz NYU Langone Medical Center Principal Investigator: Luigi DiBiase Montefiore
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