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

Biosense Webster

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: QDOT MICRO System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04545619

BWI_2019_09

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Paroxysmal and Early Persistent AFIB

Experimental group

Treatment:

Device: QDOT MICRO System