Status:
COMPLETED
Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation
Lead Sponsor:
Biosense Webster, Inc.
Conditions:
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed 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 ...
Eligibility Criteria
Inclusion
- Key
- Symptomatic paroxysmal AF with one electrocardiographically documented AF episode within 6 months prior to enrollment and a a physician's note indicating recurrent self-terminating AF within 7 days . Documentation may include electrocardiogram (ECG); Transtelephonic monitoring (TTM), Holter monitor or telemetry strip.
- Failed at least one Class I or Class III antiarrhythmic drug as evidenced by recurrent symptomatic AF, contraindicated, or intolerable to the AAD.
- Age 18 years or older.
- Key
Exclusion
- Previous surgical or catheter ablation for atrial fibrillation.
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- Previously diagnosed with persistent or long-standing persistent AF and/or Continuous AF \> 7 days.
- Valve repair or replacement or presence of a prosthetic valve.
- CABG surgery within the past 6 months (180 days).
- Any carotid stenting or endarterectomy within the past 6 months.
- Coronary artery bypass grafting, cardiac surgery, or valvular cardiac surgical procedure within the past 6 months.
- Documented left atrium (LA) thrombus within 1 day prior to the index procedure.
- Documented LA size \> 50 mm.
- Documented LVEF \< 40%.
- Contraindication to anticoagulation (e.g., heparin).
- MI/PCI within the past 2 months.
- Documented thromboembolic event (including transient ischemic attack) within the past 12 months.
- Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV.
- Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.
- Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD).
- Women who are pregnant, lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation.
Key Trial Info
Start Date :
January 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2022
Estimated Enrollment :
283 Patients enrolled
Trial Details
Trial ID
NCT03775512
Start Date
January 30 2019
End Date
February 17 2022
Last Update
March 16 2023
Active Locations (22)
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1
Grandview Medical Center
Birmingham, Alabama, United States, 35243
2
University of Alabama
Birmingham, Alabama, United States, 35294
3
JFK Medical Center
Atlantis, Florida, United States, 33462
4
Ascension St. Vincent's
Jacksonville, Florida, United States, 32204