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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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