Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Main Arm
Subjects will be ablated with the QDOT Micro Catheter for Pulmonary Vein Isolation with nMARQ RF Generator
  • Device: RF Ablation with QDOT Micro
    Subjects will be ablated using QDOT Micro catheter
Experimental
Second Arm (variable flow)
subjects will be treated with QDOT Micro catheter with variable flow nMARQ RF generator
  • Device: RF Ablation with QDOT Micro
    Subjects will be ablated using QDOT Micro catheter

Recruiting Locations

Montefiore Medical Center - Albert Einstein
Bronx, New York 10467
Contact:
Dalvert Polanco
718-920-6442
dapolanc@montefiore.org

More Details

Status
Recruiting
Sponsor
Biosense Webster, Inc.

Study Contact

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 has two arms: main arm and second arm (variable flow). The main arm will enroll 185 subjects and second arm will enroll 92 subjects.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.