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Completed

NCT Number: NCT04545619

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cardiologie de Montréal (Montreal Heart Institute)

Montreal, Quebec, H1T 1C8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects diagnosed with symptomatic paroxysmal or early persistent AF undergoing a catheter ablation procedure through pulmonary vein isolation.
  • Age 18 or older.
  • Signed the Patient Informed Consent Form (ICF).

Exclusion criteria

  • If the patient has had a ventriculotomy or atriotomy within the preceding twelve weeks.
  • Presence of a myxoma or an intracardiac thrombus.
  • Presence of prosthetic valves.
  • Presence of active systemic infection
  • Patient with an interatrial baffle or patch
  • 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.

Treatment and study plan

QDOT MICRO System

Device

QDOT Micro Catheter with nGEN Generator

Primary outcomes

  1. Number of Participants Who Achieved Acute Procedural Success

    Time frame: Up to 104 days

    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.

Secondary outcomes

  1. Number of Participants With Adverse Events (AEs)

    Time frame: Up to 104 days

    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.

Sponsors and collaborators

Lead sponsor

Biosense Webster, Inc.

Industry

Registry information

Official study title

Acute Performance Evaluation of the QDOT Micro™ Catheter Used With nGEN Generator in Treatment of Patients With Atrial Fibrillation.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 11, 2020
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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