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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00721149
Other study ID # BWI03130TXA
Secondary ID
Status Terminated
Phase Phase 3
First received July 21, 2008
Last updated December 3, 2013
Start date September 2008
Est. completion date December 2009

Study information

Verified date December 2013
Source Biosense Webster, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 10
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Device:
Radiofrequency Ablation
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.

Locations

Country Name City State
United States Cleveland Clinic Foundation Cleveland Ohio
United States Ohio State University Medical Center Columbus Ohio
United States Duke University Medical Center Durham North Carolina
United States University of Rochester Medical Center Rochester New York

Sponsors (1)

Lead Sponsor Collaborator
Biosense Webster, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Subjects Who Exhibited no Documented Symptomatic Paroxysmal Atrial Fibrillation (PAF) Episodes 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 No
Primary The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Catheter-related Adverse Events. 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 Yes
Secondary Percentage of Subjects Who Achieved Acute Success 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 Yes
Secondary 24-hour Holter Data 1 year No
Secondary TTM Data 1 year No
Secondary Percentage of Subjects Who Responded to Quality of Life Assessment SF 36 Symptom Frequency and Severity Checklist 1 year No
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