Atrial Fibrillation Recurrence After Cryoballoon Ablation

NCT ID: NCT01772030

Last Updated: 2020-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2019-08-07

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Recurrent Atrial Fibrillation

Group Type OTHER

Use of the Achieve catheter followed by ICE-guided mapping catheter

Intervention Type OTHER

Interventions

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Use of the Achieve catheter followed by ICE-guided mapping catheter

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Unable to give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Sandeep Jain

Associate Professor of Medicine, Cardiac Electrophysiology, University of Pittsburgh

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sandeep K Jain, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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UPMC Presbyterian Shadyside

Pittsburgh, Pennsylvania, United States

Site Status

UPMC Passavant

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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PRO12060524

Identifier Type: -

Identifier Source: org_study_id

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