Performance of QDOT Micro™ Catheter With nGEN Generator for Patients With AFIB.

Biosense Webster, Inc.40 enrolled

Overview

This workflow study will further evaluate the acute performance and safety of the QDOT MICRO™ catheter in a clinical setting used in combination with nGEN Generator. Subjects will be followed for 7 days post procedure.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Atrial Fibrillation

Interventions

QDOT MICRO SystemDEVICE

QDOT Micro Catheter with nGEN Generator

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects diagnosed with symptomatic paroxysmal or early persistent AF undergoing a catheter ablation procedure through pulmonary vein isolation. 2. Age 18 or older. 3. Signed the Patient Informed Consent Form (ICF). Exclusion Criteria: 1. If the patient has had a ventriculotomy or atriotomy within the preceding twelve weeks. 2. Presence of a myxoma or an intracardiac thrombus. 3. Presence of prosthetic valves. 4. Presence of active systemic infection 5. Patient with an interatrial baffle or patch 6. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation.

Locations (1)

Institut de Cardiologie de Montréal (Montreal Heart Institute)

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Number of Participants Who Achieved Acute Procedural Success

Number of participants who achieved acute procedural success were reported. Acute procedural success was defined as confirmation of entrance block in all targeted pulmonary veins (PVs) after administration of adenosine/isoproterenol using the nGEN / QDOT Micro Ablation System. The participants without any QMODE+ applications for PVI were considered as a failure.

Time frame: Up to 104 days

Secondary Outcomes

Number of Participants With Adverse Events (AEs)

Number of participants with AEs were reported. An AE was any untoward medical occurrence whether or not related to the study device or ablation procedure.

Time frame: Up to 104 days

Data from ClinicalTrials.gov

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