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

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: QDOT MICRO System

• Registration Number: NCT04545619
• Lead Sponsor: Biosense Webster, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-18
• Study First Submitted QC: 2020-09-10
• Study First Posted: 2020-09-11
• Study Start: 2020-10-02
• Primary Completion: 2021-11-09
• Study Completion: 2021-11-09
• Status Verified: 2022-11
• Results First Submitted: 2022-11-09
• Results First Submitted QC: 2022-11-09
• Last Update Submitted: 2022-11-09
• Results First Posted: 2022-12-02
• Last Update Posted: 2022-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paroxysmal and Early Persistent AFIB	QDOT MICRO System	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Achieved Acute Procedural Success	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 Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs)	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.

Trial Locations

Locations (1)

Institut de Cardiologie de Montréal (Montreal Heart Institute); 🇨🇦 Montréal, Quebec, Canada