Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation

Summary

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.

Conditions

• Paroxysmal Atrial Fibrillation

Interventions

DEVICE

RF Ablation with QDOT Micro

Subjects will be ablated using QDOT Micro catheter

Sponsors & Collaborators

• Biosense Webster, Inc.

  lead INDUSTRY

Principal Investigators

• Emile Daoud · Ohio State University

• Jose Osorio · Grandview Medical Center

• Francis Marchlinksi · University of Pennsylvania Health System

• Michael Cutler · Intermountain Medical Center

• Andrea Natale · Texas Cardiac Arrhythmia Research Foundation

• Daniel Melby · Abbott Northwestern

• Miguel Valderabanno · The Methodist Hospital Research Institute

• George Monir · AdventHealth

• Craig Delaughter · Texas Heart Health and Vascular

• Christopher Liu · New York Presbyterian Hospital

• Saumil Oza · Ascension St. Vincent's

• Ayman Hussein · The Cleveland Clinic

• Robert Fishel · JFK Hospital

• Kenneth Ellenbogen · VCU

• Gery Tomassoni · Baptist Hospital

• Tristram Bahnson · Duke University

• Chris Ellis · VUMC

• Emerson Liu · Allegheny College

• David Wilber · Loyola University

• Moussa Mansour · Massachusetts General Hospital

• Srinivas Dukkipati · Icahn School of Medicine at Mount Sinai

• Hugh McElderry · University of Alabama at Birmingham

• Ashish Patel · Wakemed Heart and Vascular

• Larry Chinitz · NYU Langone Medical Center

• Luigi DiBiase · Montefiore

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-30

Primary Completion

2022-02-17

Completion

2022-02-17

FDA Device

Yes

Countries

• United States

Study Locations