Automated Assessment of PVI Using a Novel EP Recording System (PVISION)

CathVision

Status: Completed

Conditions: Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation

Treatments: Device: CathVision Cube® system

Study type: Interventional

Funder types: Industry

Identifiers

NCT05043883

CPVI-002

Details and patient eligibility

About

A prospective, multi-center study with the CathVision Cube® system and the PVI Analyzer software in radiofrequency (RF), cryo-balloon (CB), and Pulse Field Ablation (PFA) procedures.

Full description

Subjects with paroxysmal or persistent atrial fibrillation (AF) who are indicated to undergo first pulmonary vein isolation (PVI) procedure and meet all eligibility criteria will be enrolled in the Study. Intracardiac signals will be passively recorded using the investigational CathVision Cube® System in parallel with the conventional (CE marked) EP recording system. The investigational device will not be used for direct clinical care decisions or therapy. The validation of the automated algorithm for PVI will be performed offline

The primary objective is to validate the PVI Analyzer software with a novel EP recording system (CathVision Cube® System) for assisting assessment of isolation status following PVI ablation.

The secondary objective is to determine the feasibility of "real-time" assessment of PVI analysis and rhythm dependent performance using the PVI Analyzer and CathVision Cube® System.

Enrollment: 101 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Eligible subjects will meet all of the following inclusion criteria:

1. Subjects undergoing first-time pulmonary vein isolation indicated by investigator for the treatment of atrial fibrillation
2. Male or non-pregnant female aged ≥21 years.
3. Able and willing to provide written informed consent prior to any clinical investigation related procedure

Eligible subjects will not meet any of the following exclusion criteria:

1. Pregnant or nursing subjects.
2. Current participation in another investigational drug or device study that interferes with this Study.
3. Subjects who, in the opinion of the investigator, are not candidates for this Study.
4. Patients who have had a prior ablation procedure
5. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
6. Life expectancy less than 12 month
7. Subjects who, in the opinion of the investigator, are considered part of any vulnerable population.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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101 participants in 1 patient group

Single Group

Experimental group

Description:

Index EP Procedure: Ablation of atrial fibrillation

Treatment:

Device: CathVision Cube® system