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Ablation

Ablation Procedures for Atrial Fibrillation (CONVERGE Trial)

Q: Are there various sites in this state conducting the experiment?

<p>The trial is available at Lahey Clinic in Burlington, Rose Medical Center / Medical Center of Aurora in Denver, East Carolina University - Vidant Medical Center in Greenville, and 22 other sites.</p>

N/A

Waitlist Available

Led By David DeLurgio, MD

Research Sponsored by AtriCure, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 month

Awards & highlights

CONVERGE Trial Summary

This trial is testing a new device to treat patients with a heart condition who haven't responded to other treatments.

Eligible Conditions

Atrial Fibrillation

CONVERGE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Efficacy Endpoint - Number of Participants to Achieve Freedom From AF/AT/AFL.

Primary Safety Analysis

Secondary outcome measures

AF Freedom Through 12 Months- Absent of an Increased Dose or New Class I/III AAD's.

Change in 6-Minute Walk Score

Change in Atrial Fibrillation Severity Scale (AFSS)

+6 more

CONVERGE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Convergent ProcedureExperimental Treatment2 Interventions

Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment

Group II: Standalone Endocardial Catheter AblationActive Control1 Intervention

Procedure/Surgery: Endocardial Catheter Ablation Treatment

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering

2013

N/A

~170

AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax

2013

N/A

~170

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AtriCure, Inc.Lead Sponsor

41 Previous Clinical Trials

17,301 Total Patients Enrolled

27 Trials studying Atrial Fibrillation

8,257 Patients Enrolled for Atrial Fibrillation

David DeLurgio, MDPrincipal InvestigatorEmory St Joseph's Hospital

Media Library

AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax (Ablation) Clinical Trial Eligibility Overview. Trial Name: NCT01984346 — N/A

Atrial Fibrillation Research Study Groups: Standalone Endocardial Catheter Ablation, Convergent Procedure

Atrial Fibrillation Clinical Trial 2023: AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax Highlights & Side Effects. Trial Name: NCT01984346 — N/A

AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax (Ablation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01984346 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the foremost aims of this clinical experiment?

"As per the study's sponsor, AtriCure Inc., this trial will follow participants for 12 months to assess its primary efficacy endpoint - number of individuals who experience freedom from AF/AT/AFL. Secondary outcomes such as changes in Quality of Life-Change in SF-36 Mental health Composite Score Using Short Form Survey (SF-36), Left Atrial Diameter at 6 Months, and Number of Patients With AF Burden Reduction of at Least 90% at 12 Months Compared to Baseline are also being monitored. The SF-36 assessment is a standardized questionnaire that gauges general mental health, limitations due to emotional issues,"

Answered by AI

Are recruitment efforts being conducted to enroll participants in this clinical trial?

"The clinicaltrials.gov data reveals that patient recruitment for this medical trial has ceased and was last updated on June 20th 2022; however, there are 476 other trials actively looking to enrol patients at this time."

Answered by AI

Is it permissible for individuals under the age of twenty to join this clinical investigation?

"This particular medical study is looking for individuals aged 18 to 80. There are 11 trials available for younger patients and 473 studies targeting a geriatric population."

Answered by AI

Is it possible for me to join this experimental program?

"This study aims to recruit 170 individuals with atrial fibrillation between the ages of 18 and 80. In order to be considered, applicants must have a left atrium dimension < 6.0 cm; As well as being refractory or intolerant towards one AAD (class I and/or III)."

Answered by AI

Are there various sites in this state conducting the experiment?

"The trial is available at Lahey Clinic in Burlington, Rose Medical Center / Medical Center of Aurora in Denver, East Carolina University - Vidant Medical Center in Greenville, and 22 other sites."

Answered by AI