NCT00477230

Brief Summary

The purpose of the study is to compare two types of treatment for atrial fibrillation (AF) that are designed to treat the symptoms of atrial fibrillation. The treatments being compared are:

  • A single catheter ablation procedure with the investigational EAS, a visually-guided, light-energy catheter
  • Standard drug therapy (antiarrhythmic drugs) To learn more about the CardioFocus ENABLE investigational clinical study, please contact the study site closest to you. Eligibility Criteria Persons with paroxysmal atrial fibrillation may be eligible for this study. Other study eligibility criteria include:
  • 18 to 80 years of age
  • Frequent episodes of AF
  • Failed at least 1 drug treatment for AF (beta-blockers or standard AADs)
  • Other criteria

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at below P25 for phase_3 atrial-fibrillation

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

18 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

June 27, 2012

Completed
Last Updated

June 27, 2012

Status Verified

June 1, 2012

Enrollment Period

2.2 years

First QC Date

May 21, 2007

Results QC Date

June 26, 2012

Last Update Submit

June 26, 2012

Conditions

Atrial Fibrillation

Keywords

AFPAFparoxysmal atrial fibrillationablationfailed drugs

Outcome Measures

Primary Outcomes (1)

  • Freedom for Symptomatic Episode of Atrial Fibrillation at One Year

    One Year

Study Arms (2)

1

EXPERIMENTAL

Single ablation procedure with Endoscopic Ablation System

Device: Endoscopic Ablation System

2

ACTIVE COMPARATOR

Medication

Drug: Standard Anti-arrhythmic Drug (AAD) Therapy

Interventions

Endoscopic Ablation SystemDEVICE

Single ablation procedure with Endoscopic Ablation System

1
Standard Anti-arrhythmic Drug (AAD) TherapyDRUG

Medication as prescribed by physician.

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 80 years old
  • Paroxysmal atrial fibrillation (AF)
  • Frequent episodes of AF
  • Failed at least 1 drug treatment
  • Others

You may not qualify if:

  • Others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Arizona Arrhythmia Consultants

Scottsdale, Arizona, 85260, United States

Location

Mercy General Hospital

Sacramento, California, 95819-3633, United States

Location

University of California at San Francisco

San Francisco, California, 94143, United States

Location

St. John's Health Center

Santa Monica, California, United States

Location

Palm Beach Heart Research Institute

Atlantis, Florida, 33462, United States

Location

Florida Hospital

Orlando, Florida, United States

Location

Indiana University, Krannert Institute of Cardiology

Indianapolis, Indiana, 46202, United States

Location

Genesis Medical Center

Davenport, Iowa, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, United States

Location

St. Luke's-Roosevelt

New York, New York, United States

Location

Strong Memorial Hosptial - University of Rochester

Rochester, New York, 14627, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19096, United States

Location

Texas Cardiac Arrhythmia Research

Austin, Texas, 78705, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Virginia

Charlottesville, Virginia, United States

Location

Sentara Cardiovascular Research Institute

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

This study was terminated early due to Sponsor decision. Therefore, full patient assignement to treatments post-randomziation did not occur. Results and other measures cannot be determined because most patients exited the study before completion.

Results Point of Contact

Title
Burke T. Barrett, Study Director
Organization
CardioFocus, Inc.
bbarrett@cardiofocus.com
508 658-7200

Study Officials

  • Vivek Reddy, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

  • Andrea Natale, MD

    Texas Cardiac Arrhythmia

    PRINCIPAL INVESTIGATOR

  • Burke Barrett

    CardioFocus, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2007

First Posted

May 23, 2007

Study Start

March 1, 2007

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

June 27, 2012

Results First Posted

June 27, 2012

Record last verified: 2012-06

Locations

US(18)