Paroxysmal Atrial FibrillationNCT00584415
Navi-Star Thermo-Cool Catheter For Ablation of Atrial Fibrillation
A study testing GP ablation + PV isolation in people with Paroxysmal Atrial Fibrillation, run by University of Oklahoma at 1 site in United States.
Trial summary
The objective of this study is to demonstrate that the NAVI-STAR THERMO-COOL catheter can be used to safely and effectively reduce symptomatic episodes of paroxysmal atrial fibrillation in patients with frequent (>3 episodes/month) or infrequent <3 episodes/month)atrial fibrillation resistant to at least one Class I… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- GP ablation + PV isolation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Feb 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater or equal to 18 years
- At least one documented episode of atrial fibrillation (AF) within the previous 6 months.
- Failure of at least one antiarrhythmic drug (Class I or III) defined as recurrence of AF or adverse effect.
- Informed consent obtained.
Who cannot join
- Left atrial thrombus
- Acute myocardial infarction within eight (8) weeks
- Atriotomy within eight (8) weeks
- Decompensated heart failure (unless the AF is thought to be a significant etiologic factor and AF ablation is clinically indicated)
- Pregnancy
- Ablation in a pulmonary vein within 4 months.
Show all 11Show fewer
- Occurrence of perforation during an ablation procedure performed less than two months prior to the planned ablation date.
- Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in the study.
- Enrolled in an investigational study evaluating another device or drug
- Unwilling to participate in the study or unavailable for follow-up visits.
- Incarcerated
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
The objective of this study is to demonstrate that the NAVI-STAR THERMO-COOL catheter can be used to safely and effectively reduce symptomatic episodes of paroxysmal atrial fibrillation in patients with frequent (>3 episodes/month) or infrequent <3 episodes/month)atrial fibrillation resistant to at least one Class I or Class III antiarrhythmic drug.
Read the detailed description
The ability of a saline irrigated catheter to deliver RF energy at higher power with a lower electrode-tissue interface temperature, combined with the anatomical guidance of electroanatomical mapping should allow:
- Isolation of the pulmonary veins at the LA-PV junction with the same or lower risk of pulmonary vein stenosis;
- Creation of continuous, transmural linear left atrial lesions with the same or lower risk of thromboembolism;
- These two factors will eliminate documented episodes of symptomatic sustained AF in patients with frequent (>3 episodes/month) or infrequent (<3 episodes/month);
- Patients with interruption of the vagal response (sinus bradycardia or AV block) during stimulation at the sites of left atrial autonomic ganglionated plexi (GP) will have lower recurrence of atrial fibrillation.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- GP ablation + PV isolation
- Keywords
- Catheter Ablation, Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP ablation + PV isolationDevice
Also called Navi-Star ThermoCool Catheter, Biosense-Webster Inc.
All patients underwent GP ablation and PV isolation using the NaviStar ThermoCool ablation catheter
| Study group | Role | What they receive |
|---|---|---|
| GP + PVI ablation | Active comparator | This study contains only one arm, which is GP ablation + PV antrum isolation. The intervention (GP ablation + PV isolation) was performed using ThermoCool Navistar catheters in all patients Receives: Device: GP ablation + PV isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial Tachyarrhythmia Recurrence in Participants
Outcome is determined by recurrence of atrial tachyarrhythmia in participants. Outcome is measured by any atrial tachyarrhythmias recorded by 12-lead ECGs, Holter monitoring or event monitoring. Recurrence of atrial tachyarrhythmia is also measured by symptoms reported by patients. Symptoms include palpitations, dizziness, dyspnea and any AF-related symptoms that existed before AF ablation.
Measured: 0-5 years
Secondary outcomes (1)
Total Number of Significant Ablation Procedure Related Complications
Any complication directly related to the ablation procedure was included. These complications included pericardial effusion, cardiac tamponade, excessive bleeding requiring transfusion, phrenic nerve injury, atrio-esophageal fistula, vascular access complications, myocardial infarction and stroke.
Measured: 0-1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startFeb 2004
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sunny Po, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584415
- Sponsor's protocol ID
- 010971
- Status last verified
- Jul 2014
- First submitted
- 20 Dec 2007
- Last updated
- 28 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navi-Star Thermo-Cool Catheter For Ablation of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00584415
- Acronym / sponsor ID
- 010971
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Catheter Ablation, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 2 Jan 2008 (estimated)
- Results
- Posted 28 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to demonstrate that the NAVI-STAR THERMO-COOL catheter can be used to safely and effectively reduce symptomatic episodes of paroxysmal atrial fibrillation in patients with frequent (>3 episodes/month) or infrequent <3 episodes/month)atrial fibrillation resistant to at least one Class I or Class III antiarrhythmic drug.
Detailed description
The ability of a saline irrigated catheter to deliver RF energy at higher power with a lower electrode-tissue interface temperature, combined with the anatomical guidance of electroanatomical mapping should allow:
- Isolation of the pulmonary veins at the LA-PV junction with the same or lower risk of pulmonary vein stenosis;
- Creation of continuous, transmural linear left atrial lesions with the same or lower risk of thromboembolism;
- These two factors will eliminate documented episodes of symptomatic sustained AF in patients with frequent (>3 episodes/month) or infrequent (<3 episodes/month);
- Patients with interruption of the vagal response (sinus bradycardia or AV block) during stimulation at the sites of left atrial autonomic ganglionated plexi (GP) will have lower recurrence of atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GP + PVI ablation | Active comparator | Device: GP ablation + PV isolationThis study contains only one arm, which is GP ablation + PV antrum isolation. The intervention (GP ablation + PV isolation) was performed using ThermoCool Navistar catheters in all patients |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater or equal to 18 years
- At least one documented episode of atrial fibrillation (AF) within the previous 6 months.
- Failure of at least one antiarrhythmic drug (Class I or III) defined as recurrence of AF or adverse effect.
- Informed consent obtained.
Key exclusion criteria (11 listed)
- Left atrial thrombus
- Acute myocardial infarction within eight (8) weeks
- Atriotomy within eight (8) weeks
- Decompensated heart failure (unless the AF is thought to be a significant etiologic factor and AF ablation is clinically indicated)
- Pregnancy
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 |
|---|---|---|
| GP ablation + PV isolationAlso: Navi-Star ThermoCool Catheter, Biosense-Webster Inc.All patients underwent GP ablation and PV isolation using the NaviStar ThermoCool ablation catheter | Device | GP + PVI ablation |
Primary outcome
Atrial Tachyarrhythmia Recurrence in Participants
Time frame: 0-5 years
Outcome is determined by recurrence of atrial tachyarrhythmia in participants. Outcome is measured by any atrial tachyarrhythmias recorded by 12-lead ECGs, Holter monitoring or event monitoring. Recurrence of atrial tachyarrhythmia is also measured by symptoms reported by patients. Symptoms include palpitations, dizziness, dyspnea and any AF-related symptoms that existed before AF ablation.
1 secondary outcome
Total Number of Significant Ablation Procedure Related Complications
Time frame: 0-1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Paroxysmal Atrial Fibrillation
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A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation
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A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
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A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
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Catheter Ablation Using a Novel Navigation and Imaging System
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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.
Sunny Po, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GP ablation + PV isolation in people with Paroxysmal Atrial Fibrillation, run by University of Oklahoma at 1 site in United States.
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 4 inclusion and 11 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 28 Jul 2014. 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 United States. 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?
Yes. Results are posted in the registry (first posted 28 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Atrial Tachyarrhythmia Recurrence in Participants (time frame: 0-5 years). 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 28 Jul 2014.