The Concomitant Cryomaze Procedure Using Nitreous Oxide Cryoprobe: Comparison With Argon Based Cryoprobe

August 22, 2017 updated by: Samsung Medical Center

Study of Cryomaze Procedure Using Nitrous Oxide Versus Argon Gas

The aim of this study is compare the surgical convenience and early and long-term outcomes of cryomaze procedure using nitrous oxide with using Argon gas.

The investigators will analyze the pathologic findings of atrial tissue after cryoablation using two probes and early and long-term outcomes with Holter monitoring. Atrial fibrillation burden 3 months and 1 year postoperatively and atrial activity will be checked.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators have used the Medtronic ATS cryoprobe (Argon based) since 2009 for cryomaze procedure for treatment of atrial fibrillation combined with valvular heart disease.

However, sometimes, it was inconvenient due to excess flexibility, wide lesion related to excess low temperature and time-consuming detachment from atrium after cryoablation. The investigators introduced Atricure cryoprobe (Nitreos Oxide based) in hope of overcoming these shortcomings of ATS probes last year.

Up to date, the investigators have been satisfactory in terms of the surgical convenience. On the other hand, we have the questionability of transmural lesion of Atricure probe because of the higher temperature of Atricure probe compared with ATS probe.

The aim of this study is compare the surgical convenience and early and long-term outcomes of cryomaze procedure using nitrous oxide with using Argon gas.

The investigators will analyze the pathologic findings of atrial tissue after cryoablation using two probes and early and long-term outcomes with Holter monitoring. Atrial fibrillation burden 3 months and 1 year postoperatively and atrial activity will be checked.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • requiring concomitant maze operation with valve surgery (persistent atrial fibrillation)
  • between 18 and 75 years old

Exclusion Criteria:

  • previous cardiac surgery
  • Behcet disease
  • Takayasu's arteritis
  • Infective endocarditis
  • Congenital heart disease
  • left atrial size over 80mm
  • moderate or greater functional tricuspid regurgitation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Argon gas probe
Cryomaze procedure using Argon gas probe
Device: Cryomaze procedure using Argon
Cryomaze procedure using Argon
Other Names:
  • ATS medtronic probe
ACTIVE_COMPARATOR: Nitrous oxide probe
Cryomaze procedure using Nitrous oxide probe
Device: Cryomaze procedure using Nitrous oxide
Cryomaze procedure using Nitrous oxide
Other Names:
  • Atricure cryoprobe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence of atrial fibrillation
Time Frame: one year
Treatment failure
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative stroke
Time Frame: one year
Thromboembolism
one year
Atrial arrhythmia events
Time Frame: one year
AF recurrence, the need for antiarrhythmic drugs for symptoms, permanent pacemaker insertion, and the need for cardioversion
one year
Cardiac related death
Time Frame: one year
Including sudden death
one year
heart failure
Time Frame: one year
heart failure requiring admission
one year
Reoperation
Time Frame: one year
reoperation due to heart problems
one year
Intracranial hemorrhage
Time Frame: one year
bleeding complication involving brain
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Pyo Won Park, MD,PhD, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

November 1, 2015

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

March 8, 2013

First Submitted That Met QC Criteria

March 13, 2013

First Posted (ESTIMATE)

March 18, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 24, 2017

Last Update Submitted That Met QC Criteria

August 22, 2017

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-11-088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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