Clinical trial NCT02257060: LINEAR II - LME-159 Evaluation of a Multi-Electrode Linear Type Ablation Catheter
Official title: Evaluation of a Multi-Electrode Linear Type Ablation Catheter for Endocardial Ablation of Patients With Right Atrial Flutter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cavotricuspid Isthmus Dependent Right Atrial Flutter
Keywords: Endocardial Ablation
Atrial Flutter
Cavotricuspid Isthmus
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 and the performance of the product when used for the treatment of symptomatic CTI (cavotricuspid isthmus) dependent right atrial flutter.


Eligibility criteria: 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 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

Primary outcomes:
measure: Safety
timeFrame: 7 Days
measure: Acute performance
timeFrame: This outcome measure will be assessed during the procedure but after 30 minutes (or more) of the initial ablation
Secondary outcomes:
measure: Safety
timeFrame: Until one-month follow-up
measure: Acute Efficacy
timeFrame: Within 30 Days
measure: Procedural data
timeFrame: During Procedure
Other outcomes:
Locations:
Study officials:
affiliation: Miulli Hospital
name: Massimo Grimaldi
role: PRINCIPAL_INVESTIGATOR
References: