Clinical Evaluation of the Blazer® Open-Irrigated Catheter for Treatment of Type 1 Atrial Flutter (NCT01253200) | Clinical Trial Compass
CompletedNot Applicable
Clinical Evaluation of the Blazer® Open-Irrigated Catheter for Treatment of Type 1 Atrial Flutter
United States302 participantsStarted 2011-01
Plain-language summary
The purpose of the BLOCk-CTI study is to evaluate the safety and effectiveness of the Blazer® Open-Irrigated Ablation Catheter for the treatment of sustained or recurrent type 1 atrial flutter. This study will compare outcomes in patients treated with the Blazer® Open-Irrigated Ablation Catheter to outcomes in patients treated with open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* At least 1 documented episode of type 1 atrial flutter in the 180 days (6 months) preceding enrollment documented by 12-lead ECG, Holter monitor, rhythm strip, or transtelephonic monitor
* Patients are clinically indicated for catheter ablation
* Patients receiving oral anti-arrhythmic drug therapy (class I or class III) for a tachyarrhythmia other than type 1 atrial flutter must be controlled on the anti-arrhythmic drug for a minimum of 30 days prior to enrollment. If type 1 atrial flutter was documented prior to the development of other tachyarrhythmias, this 30-day period is not required.
* Age 18 or above, or of legal age to give informed consent specific to state and national law
* Patients are competent and willing to provide written informed consent to participate in the study and agree to comply with follow-up visits and evaluation
Exclusion Criteria:
* Any prior right atrial cavo-tricuspid isthmus ablation or any cardiac ablation for non-atrial flutter arrhythmias within 90 days prior to enrollment
* Cardiac surgery within 90 days prior to enrollment
* Myocardial infarction within 60 days prior to enrollment
* Current unstable angina
* Patients who cannot have anti-arrhythmic drugs (class I and class III) prescribed for the treatment of type 1 atrial flutter stopped on the day of the procedure
* Patients regularly prescribed amiodarone within the 120 days (4 months) prior to enrollment
* Documented atrial or ventricular tumors, clots, thrombu…
What they're measuring
1
Procedure-related Complication-free Rate
Timeframe: 7 days post-procedure
2
Acute Success Rate
Timeframe: 30 minutes after the last radiofrequency application in the cavo-tricuspid isthmus