- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00721149
NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation- Treatment Use Study (AFTX)
December 3, 2013 updated by: Biosense Webster, Inc.
This trial evaluates the safety and effectiveness of catheter ablation for PAF.
The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter.
At the time of this study, the NAVISTAR® THERMOCOOL® Catheter was FDA-approved for commercial distribution in the U.S. for treating patients with Type I atrial flutter and drug refractory monomorphic sustained ventricular tachycardia post myocardial infarction.
The catheter was approved for use in Europe for endocardial ablation for treating cardiac arrhythmias.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 3
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
-
-
New York
-
Rochester, New York, United States, 14642
- University of Rochester Medical Center
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-
North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
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Columbus, Ohio, United States, 43210
- Ohio State University Medical Center
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-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with symptomatic PAF who have had three (3) AF episodes in the six (6) months prior to enrollment, one of which must be documented. Documentation may include electrocardiogram (ECG), transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip.
- Failure of at least one AAD for PAF [class I or III or AV nodal blocking agents such as beta blockers (BB) and calcium channel blockers (CCB)] as evidenced by recurrent symptomatic PAF, or intolerable side effects due to AAD.
- Signed Patient Informed Consent Form.
- Age 18 years or older.
- Able and willing to comply with all pre-, post- and follow-up testing and requirements.
Exclusion Criteria:
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non- cardiac cause.
- Previous ablation for atrial fibrillation.
- Patients on amiodarone therapy at any time during the previous six (6) months.
- AF episodes that last longer than 30 days and are terminated via cardioversion.
- Any valvular cardiac surgical procedure.
- CABG procedure within the last 180 days (six months).
- Awaiting cardiac transplantation or other cardiac surgery within the next 360 days (12 months).
- Documented left atrial thrombus on imaging (e.g. TEE).
- History of a documented thromboembolic event within the past one (1) year.
- Diagnosed atrial myxoma.
- Presence of implanted ICD.
- Significant pulmonary disease, (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.
- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
- Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable).
- Acute illness or active systemic infection or sepsis.
- Unstable angina.
- Myocardial infarction within the previous 60 days (two months).
- LVEF < 40%.
- History of blood clotting or bleeding abnormalities.
- Contraindication to anticoagulation (i.e. heparin or warfarin).
- Contraindication to CT/MRA procedure.
- Life expectancy less than 360 days (12 months).
- Enrollment in an investigational study evaluating another device or drug.
- Uncontrolled heart failure or NYHA class III or IV heart failure.
- Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.
- Presence of a condition that precludes vascular access.
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
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NaviStar ThermoCool
|
The Biosense Webster® NAVISTAR THERMOCOOL Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Subjects Who Exhibited no Documented Symptomatic Paroxysmal Atrial Fibrillation (PAF) Episodes From Study Day 91 Through Day 361.
Time Frame: From study day 91 through day 361
|
A subject who exhibited no documented symptomatic PAF episodes was one who 1) had 2 or fewer repeat ablations within 90 days of the initial ablation with investigational catheter; 2) had an addition of antiarrhythmic medication which was previously ineffective for atrial fibrillation and did not exceed the previous historical maximum dosage (24 hour total dose); 3) was on atrioventricular nodal blocking agents such as beta blockers and/or calcium channel blockers and might be maintained at the current dose (ie, did not exceed previous historical maximum dosage (24 hour total dose).
|
From study day 91 through day 361
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The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Catheter-related Adverse Events.
Time Frame: within 7 days of ablation procedure
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Catheter-related adverse events include death, myocardial infarction, pulmonary vein stenosis, diaphragmatic paralysis, atrio-esophageal fistula, transient ischemic attack, stroke, cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade, pericardial effusion, pneumothorax, atrial perforation, vascular access complications, pulmonary edema, hospitalization (initial and prolonged), and heart block.
|
within 7 days of ablation procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Subjects Who Achieved Acute Success
Time Frame: Day 91 - 361
|
Acute success is defined as the confirmation of entrance block in all targeted pulmonary veins.
Acute failure is defined as subjects who have a non-investigational catheter used for ablation of any atrial fibrillation targets or subjects who undergo more than 2 repeat ablation procedures or an ablation procedure beyond day 90.
|
Day 91 - 361
|
24-hour Holter Data
Time Frame: 1 year
|
1 year
|
|
TTM Data
Time Frame: 1 year
|
1 year
|
|
Percentage of Subjects Who Responded to Quality of Life Assessment
Time Frame: 1 year
|
SF 36 Symptom Frequency and Severity Checklist
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Wilber, MD, Loyola University Medical Center Chicago
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
September 1, 2008
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
July 21, 2008
First Submitted That Met QC Criteria
July 22, 2008
First Posted (Estimate)
July 23, 2008
Study Record Updates
Last Update Posted (Estimate)
January 22, 2014
Last Update Submitted That Met QC Criteria
December 3, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BWI03130TXA
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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