Atrial FibrillationNCT01812356
The Concomitant Cryomaze Procedure Using Nitreous Oxide Cryoprobe: Comparison With Argon Based Cryoprobe
A study testing Cryomaze procedure using Nitrous oxide and Cryomaze procedure using Argon in people with Atrial Fibrillation and Valve, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation, Valve
- What is being tested?
- Cryomaze procedure using Nitrous oxide and Cryomaze procedure using Argon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- requiring concomitant maze operation with valve surgery (persistent atrial fibrillation)
- between 18 and 75 years old
Who cannot join
- previous cardiac surgery
- Behcet disease
- Takayasu's arteritis
- Infective endocarditis
- Congenital heart disease
- left atrial size over 80mm
- moderate or greater functional tricuspid regurgitation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation, Valve
- Being tested
- Cryomaze procedure using Nitrous oxide, Cryomaze procedure using Argon
- Keywords
- Atrial fibrillation, maze operation, cryoablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryomaze procedure using Nitrous oxideDevice
Also called Atricure cryoprobe
Cryomaze procedure using Nitrous oxide
Cryomaze procedure using ArgonDevice
Also called ATS medtronic probe
Cryomaze procedure using Argon
| Study group | Role | What they receive |
|---|---|---|
| Argon gas probe | Experimental | Cryomaze procedure using Argon gas probe Receives: Device: Cryomaze procedure using Argon |
| Nitrous oxide probe | Active comparator | Cryomaze procedure using Nitrous oxide probe Receives: Device: Cryomaze procedure using Nitrous oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of atrial fibrillation
Treatment failure
Measured: one year
Secondary outcomes (6)
Postoperative stroke
Thromboembolism
Measured: one year
Atrial arrhythmia events
AF recurrence, the need for antiarrhythmic drugs for symptoms, permanent pacemaker insertion, and the need for cardioversion
Measured: one year
Cardiac related death
Including sudden death
Measured: one year
heart failure
heart failure requiring admission
Measured: one year
Reoperation
reoperation due to heart problems
Measured: one year
Intracranial hemorrhage
bleeding complication involving brain
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionNov 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pyo Won Park, MD,PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812356
- Sponsor's protocol ID
- 2012-11-088
- Status last verified
- Mar 2016
- First submitted
- 8 Mar 2013
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cryomaze Procedure Using Nitrous Oxide Versus Argon Gas
- ClinicalTrials.gov ID
- NCT01812356
- Acronym / sponsor ID
- 2012-11-088
- Conditions
- Atrial Fibrillation, Valve
- Keywords
- Atrial fibrillation, maze operation, cryoablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Argon gas probe | Experimental | Device: Cryomaze procedure using ArgonCryomaze procedure using Argon gas probe |
| Nitrous oxide probe | Active comparator | Device: Cryomaze procedure using Nitrous oxideCryomaze procedure using Nitrous oxide probe |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- requiring concomitant maze operation with valve surgery (persistent atrial fibrillation)
- between 18 and 75 years old
Key exclusion criteria (7 listed)
- previous cardiac surgery
- Behcet disease
- Takayasu's arteritis
- Infective endocarditis
- Congenital heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryomaze procedure using Nitrous oxideAlso: Atricure cryoprobeCryomaze procedure using Nitrous oxide | Device | Nitrous oxide probe |
| Cryomaze procedure using ArgonAlso: ATS medtronic probeCryomaze procedure using Argon | Device | Argon gas probe |
Primary outcome
recurrence of atrial fibrillation
Time frame: one year
Treatment failure
6 secondary outcomes
Postoperative stroke
Time frame: one year
Atrial arrhythmia events
Time frame: one year
Cardiac related death
Time frame: one year
heart failure
Time frame: one year
Reoperation
Time frame: one year
Intracranial hemorrhage
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pyo Won Park, MD,PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryomaze procedure using Nitrous oxide and Cryomaze procedure using Argon in people with Atrial Fibrillation and Valve, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence of atrial fibrillation (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2017.