Status:
COMPLETED
LINEAR II - LME-159 Evaluation of a Multi-Electrode Linear Type Ablation Catheter
Lead Sponsor:
Biosense Webster, Inc.
Conditions:
Cavotricuspid Isthmus Dependent Right Atrial Flutter
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 an...
Eligibility Criteria
Inclusion
- 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
- 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 clinical investigation
- Currently enrolled in another device, biologics, or drug study
- Contraindication for use of the investigational catheter, as indicated in the respective Instructions For Use
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02257060
Start Date
September 1 2014
End Date
May 1 2015
Last Update
February 3 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.