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

Primary Purpose

Atrial Fibrillation

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

QDOT MICRO System

About this trial

This is an interventional other trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Institut de Cardiologie de Montréal (Montreal Heart Institute)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paroxysmal and Early Persistent AFIB

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04545619

First Posted

August 18, 2020

Last Updated

November 9, 2022

Sponsor

Biosense Webster, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04545619

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

October 2, 2020 (Actual)

Primary Completion Date

November 9, 2021 (Actual)

Study Completion Date

November 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biosense Webster, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Paroxysmal and Early Persistent AFIB

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

QDOT MICRO System

Intervention Description

QDOT Micro Catheter with nGEN Generator

Primary Outcome Measure Information:

Title

Number of Participants Who Achieved Acute Procedural Success

Description

Time Frame

Up to 104 days

Secondary Outcome Measure Information:

Title

Number of Participants With Adverse Events (AEs)

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Institut de Cardiologie de Montréal (Montreal Heart Institute)

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H1T 1C8

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

IPD Sharing URL

http://yoda.yale.edu

Learn more about this trial

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

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