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

• Sponsor: Biosense Webster, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04545619
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Actual Duration (Months): 13.2
• Patients Per Site Per Month: 3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Device: QDOT MICRO System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Acute Performance Evaluation of the QDOT Micro™ Catheter Used With nGEN Generator in Treatment of Patients With Atrial Fibrillation.
• Actual Study Start Date: Oct 2, 2020
• Actual Primary Completion Date: Nov 9, 2021
• Actual Study Completion Date: Nov 9, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Paroxysmal and Early Persistent AFIB	Device: QDOT MICRO System; QDOT Micro Catheter with nGEN Generator

Outcome Measures

Primary Outcome Measures

1. Acute Procedural Success [7 Days Post Procedure]

   Confirmation of entrance block in all targeted PVs after adenosine and/or isoproterenol challenge using the nGEN / QDOT Micro Ablation System

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut de Cardiologie de Montréal (Montreal Heart Institute)	Montréal	Quebec	Canada	H1T 1C8

Sponsors and Collaborators

• Biosense Webster, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biosense Webster, Inc.
• ClinicalTrials.gov Identifier: NCT04545619
• Other Study ID Numbers: BWI_2019_09
• First Posted: Sep 11, 2020
• Last Update Posted: Apr 19, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Apr 19, 2022