LINEAR II - LME-159 Evaluation of a Multi-Electrode Linear Type Ablation Catheter (NCT02257060) | Clinical Trial Compass
CompletedPhase 1
LINEAR II - LME-159 Evaluation of a Multi-Electrode Linear Type Ablation Catheter
12 participantsStarted 2014-09
Plain-language summary
The Linear II study is a prospective, single center, non-randomized, interventional feasibility study with the purpose of assessing acute safety of the Multi-Electrode Linear Type Ablation Catheter and the performance of the product when used for the treatment of symptomatic CTI (cavotricuspid isthmus) dependent right atrial flutter.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* At least one symptomatic episode of typical CTI dependent right atrial flutter documented by 12 lead ECG, Holter monitor, transtelephonic event monitor, telemetry strip, or implanted device.
* Age 18 years or older.
Exclusion Criteria:
* Previous typical CTI dependent right atrial flutter ablation
* Uncontrolled heart failure or NYHA function class IV
* MI within the past 2 months
* Any cardiac surgery (i.e. CABG) within the past 2 months
* Subjects that have ever undergone valvular cardiac surgical procedure (ie, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
* Awaiting cardiac transplantation or other cardiac surgery within the next 6 months
* Documented thromboembolic event (including TIA) within the past 12 months
* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
* Active illness or active systemic infection or sepsis
* Unstable angina
* History of blood clotting or bleeding abnormalities
* Contraindication to anticoagulation (eg, heparin or warfarin)
* Life expectancy less than 6 months
* Presence of intracardiac thrombus, myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation
* Presence of a condition that precludes vascular access
* Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the clinic…
What they're measuring
1
Safety
Timeframe: 7 Days
2
Acute performance
Timeframe: This outcome measure will be assessed during the procedure but after 30 minutes (or more) of the initial ablation