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

NCT04545619 | Completed Results FDA Device

• 1 other identifier: BWI_2019_09
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 104 days

Secondary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  Up to 104 days

Study Arms (1)

Paroxysmal and Early Persistent AFIB

EXPERIMENTAL

Device: QDOT MICRO System

Interventions

QDOT MICRO System DEVICE

QDOT Micro Catheter with nGEN Generator

Paroxysmal and Early Persistent AFIB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (1)

Institut de Cardiologie de Montréal (Montreal Heart Institute)

Montreal, Quebec, H1T 1C8, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Associate Director Clinical Research
• Organization: Biosense Webster, Inc.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: September 11, 2020
• Study Start: October 2, 2020
• Primary Completion: November 9, 2021
• Study Completion: November 9, 2021
• Last Updated: June 29, 2025
• Results First Posted: December 2, 2022

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)