NCT01057394

Brief Summary

To compare the safety and chronic Pulmonary Vein isolation of 2 ablation types.

  1. 1.visually guided ablation (VGA) using the EAS-AC and
  2. 2.radiofrequency ablation

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2009

Geographic Reach
2 countries

2 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

December 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

August 1, 2016

Completed
Last Updated

August 1, 2016

Status Verified

July 1, 2016

Enrollment Period

1.5 years

First QC Date

January 26, 2010

Results QC Date

April 18, 2016

Last Update Submit

July 27, 2016

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Rate of Permanent Pulmonary Vein Isolation of EAS-AC Compared to EAM Guided Radiofrequency Ablation

    Number of initially isolated pulmonary veins that remain isolated at a 3 month remapping. The unit of measure is treated pulmonary veins (PVs).

    3 Months

Study Arms (2)

Radiofrequency Ablation

ACTIVE COMPARATOR

PVI using RF ablation

Device: RF PVI Ablation

Visually Guided Ablation

EXPERIMENTAL

PVI using visually guided ablation with an endoscopic ablation system

Device: Endoscopically guided PVI Ablation

Interventions

Endoscopically guided PVI AblationDEVICE

Endoscopically Guided Ablation using the EAS-AC

Visually Guided Ablation
RF PVI AblationDEVICE

Radiofrequency ablation

Radiofrequency Ablation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* Symptomatic, Paroxysmal Atrial Fibrillation (AF) * 18 to 75 Years of age * Generally good overall health as determined by multiple criteria * Willing to participate in a study * Others

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Institute for Clinical and Experimental Medicine (IKEM)

Prague, 140 21, Czechia

Location

Catholic University of the Sacred Heart

Rome, 00168, Italy

Location

Related Links

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

  • Vivek Reddy, MD

    The Mount Sinai Hospital, New York City

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2010

First Posted

January 27, 2010

Study Start

December 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

August 1, 2016

Results First Posted

August 1, 2016

Record last verified: 2016-07

Locations

CZ(1)IT(1)