NCT00958165

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2009

Typical duration for phase_3

Geographic Reach
1 country

3 active sites

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

August 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

July 27, 2016

Completed
Last Updated

August 30, 2016

Status Verified

July 1, 2016

Enrollment Period

2.6 years

First QC Date

August 12, 2009

Results QC Date

April 18, 2016

Last Update Submit

July 27, 2016

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Treatment of PAF using EAS-AC

Outcome Measures

Primary Outcomes (1)

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

    12 months

Study Arms (1)

EAS-AC

EXPERIMENTAL

PVI with EAS-AC

Device: CardioFocus EAS-AC

Interventions

CardioFocus EAS-ACDEVICE

PVI for PAF

EAS-AC

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
  • Failure of at least one AAD
  • 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 (3)

Cardioangiologisches Centrum Bethanien - CCB

Frankfurg, 60431, Germany

Location

St. Georg Hosptial

Hamburg, 20099, Germany

Location

Universität Leipzig - Herzzentrum

Leipzig, 04289, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

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

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

August 12, 2009

First Posted

August 13, 2009

Study Start

August 1, 2009

Primary Completion

March 1, 2012

Study Completion

May 1, 2012

Last Updated

August 30, 2016

Results First Posted

July 27, 2016

Record last verified: 2016-07

Locations

DE(3)