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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04545619
• Other study ID #: BWI_2019_09
• Status: Completed
• Phase: N/A
• Start date: October 2, 2020
• Est. completion date: November 9, 2021

Study information

• Verified date: November 2022
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 9, 2021
• Est. primary completion date: November 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• QDOT MICRO System
QDOT Micro Catheter with nGEN Generator

Locations

Country	Name	City	State
Canada	Institut de Cardiologie de Montréal (Montreal Heart Institute)	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Up to 104 days