NCT01196923

Brief Summary

The purpose of this study is to confirm the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact in the treatment of atrial fibrillation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_4 atrial-fibrillation

Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_4 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

July 27, 2016

Completed
Last Updated

July 27, 2016

Status Verified

June 1, 2016

Enrollment Period

1.5 years

First QC Date

September 7, 2010

Results QC Date

April 18, 2016

Last Update Submit

June 16, 2016

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Acute Isolation of Pulmonary Veins.

    99% of pulmonary veins were isolated (72/73)

    Acute PVI measured on the day of treatment

Study Arms (1)

HeartLight Ablation

EXPERIMENTAL
Device: Endoscopically Guided Ablation

Interventions

Endoscopically Guided AblationDEVICE

Visually Guided Ablation using EAS-AC

HeartLight Ablation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic, Paroxysmal Atrial Fibrillation (AF)
  • to 70 Years of age
  • Others

You may not qualify if:

  • Generally good overall health as determined by multiple criteria
  • Willing to participate in a study
  • Others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Cardiologico Monzino

Milan, Italy

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Burke Barrett, VP, Regulatory & Clinical Affairs
Organization
CardioFocus, Inc.
bbarrett@cardiofocus.com
508 658-7200

Study Officials

  • Burke Barrett

    CardioFocus

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2010

First Posted

September 9, 2010

Study Start

September 1, 2010

Primary Completion

March 1, 2012

Study Completion

June 1, 2012

Last Updated

July 27, 2016

Results First Posted

July 27, 2016

Record last verified: 2016-06

Locations

IT(1)