Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic AF

CardioFocus81 enrolled

Overview

The purpose of this study is to determine the safety and effectiveness of the endoscopic ablation system - adaptive contact (EAS-AC) in treated paroxysmal atrial fibrillation (PAF) with pulmonary vein isolation (PVI).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Paroxysmal Atrial Fibrillation

Interventions

CardioFocus EAS-ACDEVICE

PVI for PAF

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Symptomatic, Paroxysmal atrial fibrillation (AF) * 18 to 70 years of age * Failure of at least one AAD * Others Exclusion Criteria: * Generally good overall health as determined by multiple criteria * Willing to participate in a study * Others

Locations (3)

Cardioangiologisches Centrum Bethanien - CCB

Frankfurg, Germany

St. Georg Hosptial

Hamburg, Germany

Universität Leipzig - Herzzentrum

Leipzig, Germany

Outcomes

Primary Outcomes

Chronic Effectiveness in Treating PAF as Demonstrated by no AF Recurrences After the Blanking Period and During the 12-month Follow-up Period.

Time frame: 12 months

Data from ClinicalTrials.gov

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