Trials Sponsors Conditions Drugs Pricing

Conditions

Atrial Fibrillation

Keywords

AFAtrial Fibrillationafibracing heartcabgvalveablationbipolarradiofrequencyrf

Outcome Measures

Primary Outcomes (2)

Primary efficacy endpoint is the proportion of treated patients who are free of atrial fibrillation without the need for anti-arrhythmic agents at the six-month follow-up visit.
6 months
The primary safety endpoint is the occurrence of serious adverse events that are considered to be associated with the Maze procedure.
30 days

Secondary Outcomes (2)

The secondary efficacy endpoint is the proportion of patients in the treatment group who are free of atrial fibrillation independent of the need for anti-arrhythmic drugs.
6 Months
The secondary safety endpoints are: total cross clamp time, total time on bypass, length of hospital stay (days), and length of ICU stay (hours)
Discharge

Interventions

Surgical bipolar radiofrequency ablation using the AtriCure Bipolar SystemDevice

Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or Female subject between 18 to 80 years of age
Subject is scheduled to undergo elective cardiac surgical procedure(s) to be performed on cardiopulmonary bypass including:

Sponsors & Collaborators

AtriCure, Inc.
Industrylead

Study Sites (10)

Heart Center of Indiana

Indianapolis, Indiana, 46290, United States

University of Michigan

Ann Arbor, Michigan, 48109, United States

Spectrum Health

Grand Rapids, Michigan, 49506, United States

Mayo Clinic

Rochester, Minnesota, 55902, United States

Washington University

St Louis, Missouri, 63110, United States

Cleveland Clinic

Cleveland, Ohio, 44195, United States

The Methodist Hospital

Houston, Texas, 77030, United States

MeSH Terms

Conditions

Atrial FibrillationTachycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCardiac Conduction System Disease

Study Officials

A. Marc Gillinov, MD
The Cleveland Clinic
PRINCIPAL INVESTIGATOR

Enrollment

39 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 3, 2007

First Posted

December 4, 2007

Study Start

January 2005

Date type not reported

This date has not been verified as actual or estimated.

Concomitant Treatment of Permanent Atrial Fibrillation

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (10)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (10)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations