NCT01772030

Brief Summary

The purpose of the study is to evaluate the mechanisms of recurrent atrial fibrillation after cryoballoon ablation using the Arctic Front Ablation System. For those with pulmonary vein reconnection, specific sites of reconnection will be evaluated with left atrial intracardiac echo (ICE) guidance. The Achieve mapping catheter will be evaluated head-to-head with our current method of ICE-guided recordings from a conventional mapping catheter with high output pulmonary venous pacing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

2 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

January 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 21, 2013

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2019

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

6.6 years

First QC Date

January 16, 2013

Last Update Submit

February 10, 2020

Conditions

Atrial Fibrillation

Keywords

Atrial FibrillationCryoballoon Ablation

Outcome Measures

Primary Outcomes (1)

  • Presence or absence of pulmonary vein isolation or reconnection

    During repeat cryoballoon ablation procedure

Study Arms (1)

Recurrent Atrial Fibrillation

OTHER
Other: Use of the Achieve catheter followed by ICE-guided mapping catheter

Interventions

Use of the Achieve catheter followed by ICE-guided mapping catheterOTHER
Recurrent Atrial Fibrillation

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing re-do catheter ablation procedure after index procedure with cryoballoon ablation
  • At least 18 years old
  • Able to read and understand informed consent

You may not qualify if:

  • Unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UPMC Presbyterian Shadyside

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Passavant

Pittsburgh, Pennsylvania, 15237, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sandeep K Jain, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine, Cardiac Electrophysiology, University of Pittsburgh

Study Record Dates

First Submitted

January 16, 2013

First Posted

January 21, 2013

Study Start

January 1, 2013

Primary Completion

August 7, 2019

Study Completion

August 7, 2019

Last Updated

February 12, 2020

Record last verified: 2020-02

Locations

US(2)