Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation (Q-FFICIENCY)

Biosense Webster

Status: Completed

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Device: RF Ablation with QDOT Micro

Study type: Interventional

Funder types: Industry

Identifiers

NCT03775512

BWI_2017_07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 283 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Key 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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283 participants in 2 patient groups

Main Arm

Experimental group

Description:

Subjects will be ablated with the QDOT Micro Catheter for Pulmonary Vein Isolation with nMARQ RF Generator

Treatment:

Device: RF Ablation with QDOT Micro

Second Arm (variable flow)

Experimental group

Description:

subjects will be treated with QDOT Micro catheter with variable flow nMARQ RF generator

Treatment:

Device: RF Ablation with QDOT Micro