Atrial FlutterPhase 4NCT00318565
Catheter Evaluation for Endocardial Ablation in Patients With Typical Atrial Flutter
A Phase 4 study testing RF energy delivery for treatment of Typical Atrial flutter in people with Atrial Flutter, run by Biosense Webster, Inc. at 23 sites in United States.
Trial summary
The primary objective is to provide additional corroborative safety and efficacy data for the Navistar Thermocool catheter for the treatment of subjects with typical atrial flutter (AFL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Flutter
- What is being tested?
- RF energy delivery for treatment of Typical Atrial flutter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 291 participants
- Where
- 23 sitesUnited States
- Study dates
- Jan 2006to Feb 2008
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Two symptomatic episodes of typical atrial flutter (or chronic atrial flutter) during the one-year period prior to enrollment. This may include typical AFL occurring while receiving anti-arrhythmic drug (AAD) therapy for non-AFL tachyarrhythmia, including atrial fibrillation.
- At least one episode of typical (clockwise or counterclockwise) atrial flutter documented by 12 lead electrocardiogram (ECG), Holter monitor, transtelephonic event monitor, telemetry strip, or implanted device within 6 months prior to enrollment.
- 18 years of age or older
- Informed consent
Who cannot join
- Intracardiac thrombus
- Uncontrolled heart failure, or New York Heart Association (NYHA) class III or IV heart failure
- Women who are pregnant
- Cardiac surgery (ventriculotomy or atriotomy) within the past two months
- Intra-atrial thrombus, tumor, or other abnormality that precludes catheter introduction and placement
- Unstable angina or acute myocardial infarction within 3 months
Show all 12Show fewer
- Awaiting cardiac transplantation
- Heart disease in which corrective surgery is anticipated within 6 months
- Presence of condition that precludes appropriate vascular access
- Enrolled in any investigational device exemption (IDE) investigating study for a device or drug
- High risk for non-compliance with the protocol (e.g., inaccessible for follow-up by the investigator or patient's physician)
- Radio frequency (RF) ablation for typical atrial flutter within the past 2 months
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
University of Maryland
Baltimore, Maryland, 21201
University of Alabama, Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Vermont, College of Medicine
Burlington, Vermont, 05401
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Chicago
Chicago, Illinois, 60637
St. John Hospital and Medical Center
Detroit, Michigan, 48236
Duke University Medical Center
Durham, North Carolina, 27710
INOVA Research Center
Falls Church, Virginia, 22042
University of Florida
Gainsville, Florida, 32611
Memorial Regional Hospital
Hollywood, Florida, 33031
Texas Heart Institute
Houston, Texas, 77030
The Care Group LLC, St. Vincent Hospital and Health Care Center, Inc.
Indianapolis, Indiana, 46060
Central Baptist Hospital
Lexington, Kentucky, 40503
Good Samaritan Hospital
Los Angeles, California, 90017
Park Nicollet Institute
Minneapolis, Minnesota, 55416
University of Oklahoma, Health Sciences Center
Oklahoma City, Oklahoma, 73104
Florida Hospital
Orlando, Florida, 32803
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Maine Medical Center
Portland, Maine, 04102
Virginia Commonwealth University
Richmond, Virginia, 23219
Pacific Heart Institute
Santa Monica, California, 90404
Arizona Arrhythmia Consultants
Scottsdale, Arizona, 85251
About this study
Official title: Navistar Thermocool Evaluation of the Catheter With the Stockert 70 Radiofrequency Generator for Endocardial Ablation in Patients With Typical Atrial Flutter
The primary objective is to provide additional corroborative safety and efficacy data for the Navistar Thermocool catheter for the treatment of subjects with typical atrial flutter (AFL).
Read the detailed description
This study is a prospective, non-randomized, single-arm, multi-center condition of approval evaluation. The device is currently FDA approved for commercial distribution. Subjects with symptomatic typical atrial flutter will be considered for the condition of approval study. This study will be conducted at up to 30 centers in a minimum of 221 evaluable subjects.
- Conditions
- Atrial Flutter
- Being tested
- RF energy delivery for treatment of Typical Atrial flutter
- Keywords
- Heart Disease, Atrial Flutter, Typical Atrial Flutter
- Medical subject headings
- Atrial Flutter, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RF energy delivery for treatment of Typical Atrial flutterDevice
Also called Therapeutic Catheters
Navistar ThermoCool catheter
| Study group | Role | What they receive |
|---|---|---|
| Navistar ThermoCool Catheter | Experimental | Not described Receives: Device: RF energy delivery for treatment of Typical Atrial flutter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Complete Bidirectional Conduction Block.
Acute success is defined as the confirmation of complete bidirectional conduction block across the subeustachian (cavo-tricuspid) isthmus. The percentage of subjects with confirmed conduction block will serve as the outcome measure.
Measured: During the procedure
Percentage of Subjects Experiencing Cardiovascular Specific Adverse Events (CSAE) Within Seven (7) Days of the Ablation Procedure.
The cardiovascular specific adverse event (CSAE) rate is the primary safety enpoint for the study. A CSAE is an event which occurs within the first week (7 days) following use of the device and is one of the following cardiac specific adverse events: cardiac perforation, pericardial effusion, pulmonary embolus, complete heart block, stroke, acute myocardial infarction, and death.
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startJan 2006
- Primary completionSep 2007
- Study completionFeb 2008
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 Atrial FlutterStudies of the same condition, open and under way.
- More trials run by Biosense Webster, Inc.The 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosense Webster, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Warren Jackman, M.D., Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318565
- Sponsor's protocol ID
- BWI30031
- Status last verified
- Mar 2012
- First submitted
- 25 Apr 2006
- Last updated
- 5 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navistar Thermocool Evaluation of the Catheter With the Stockert 70 Radiofrequency Generator for Endocardial Ablation in Patients With Typical Atrial Flutter
- ClinicalTrials.gov ID
- NCT00318565
- Acronym / sponsor ID
- BWI30031
- Conditions
- Atrial Flutter
- Keywords
- Heart Disease, Atrial Flutter, Typical Atrial Flutter
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Biosense Webster, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 27 Apr 2006 (estimated)
- Results
- Posted 2 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to provide additional corroborative safety and efficacy data for the Navistar Thermocool catheter for the treatment of subjects with typical atrial flutter (AFL).
Detailed description
This study is a prospective, non-randomized, single-arm, multi-center condition of approval evaluation. The device is currently FDA approved for commercial distribution. Subjects with symptomatic typical atrial flutter will be considered for the condition of approval study. This study will be conducted at up to 30 centers in a minimum of 221 evaluable subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Navistar ThermoCool Catheter | Experimental | Device: RF energy delivery for treatment of Typical Atrial flutter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Two symptomatic episodes of typical atrial flutter (or chronic atrial flutter) during the one-year period prior to enrollment. This may include typical AFL occurring while receiving anti-arrhythmic drug (AAD) therapy for non-AFL tachyarrhythmia, including atrial fibrillation.
- At least one episode of typical (clockwise or counterclockwise) atrial flutter documented by 12 lead electrocardiogram (ECG), Holter monitor, transtelephonic event monitor, telemetry strip, or implanted device within 6 months prior to enrollment.
- 18 years of age or older
- Informed consent
Key exclusion criteria (12 listed)
- Intracardiac thrombus
- Uncontrolled heart failure, or New York Heart Association (NYHA) class III or IV heart failure
- Women who are pregnant
- Cardiac surgery (ventriculotomy or atriotomy) within the past two months
- Intra-atrial thrombus, tumor, or other abnormality that precludes catheter introduction and placement
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 |
|---|---|---|
| RF energy delivery for treatment of Typical Atrial flutterAlso: Therapeutic CathetersNavistar ThermoCool catheter | Device | Navistar ThermoCool Catheter |
Primary outcome
Percentage of Subjects With Complete Bidirectional Conduction Block.
Time frame: During the procedure
Acute success is defined as the confirmation of complete bidirectional conduction block across the subeustachian (cavo-tricuspid) isthmus. The percentage of subjects with confirmed conduction block will serve as the outcome measure.
Percentage of Subjects Experiencing Cardiovascular Specific Adverse Events (CSAE) Within Seven (7) Days of the Ablation Procedure.
Time frame: 7 Days
The cardiovascular specific adverse event (CSAE) rate is the primary safety enpoint for the study. A CSAE is an event which occurs within the first week (7 days) following use of the device and is one of the following cardiac specific adverse events: cardiac perforation, pericardial effusion, pulmonary embolus, complete heart block, stroke, acute myocardial infarction, and death.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Atrial Flutter
Recruiting
Anatomical Navigation for Guided Electrophysiology in AFL and AFib
Atrial Fibrillation, Atrial Flutter
Recruiting
Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures
Atrial Fibrillation, Atrial Flutter
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Active, not recruiting
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System
Persistent Atrial Fibrillation
Recruiting
Pericardiotomy in Cardiac Surgery
Atrial Fibrillation, Atrial Flutter
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.
Warren Jackman, M.D. principal investigator
University of Oklahoma
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing RF energy delivery for treatment of Typical Atrial flutter in people with Atrial Flutter, run by Biosense Webster, Inc. at 23 sites 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 12 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 5 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2010). 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?
Percentage of Subjects With Complete Bidirectional Conduction Block. (time frame: During the procedure). The study lists 2 primary outcomes in all. 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 5 Mar 2012.