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
Sponsored by
About this trial
This is an interventional other trial for Atrial Fibrillation
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.
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
No
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
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 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
No
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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