Cavotricuspid Isthmus Dependent Right Atrial Flutter
Conditions
Keywords
Endocardial Ablation, Atrial Flutter, Cavotricuspid Isthmus
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.
Interventions
PROCEDUREEndocardial Ablation
Sponsors
Biosense Webster, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 7 Days | Incidence of early onset (within 7 days of ablation procedure) primary AEs |
| Acute performance | This outcome measure will be assessed during the procedure but after 30 minutes (or more) of the initial ablation | Acute procedural success as confirmed complete bidirectional conduction block across the CTI (assess ≥30 min following last RF application) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | Until one-month follow-up | Incidence of Serious Adverse Events during follow-up |
| Acute Efficacy | Within 30 Days | Right atrial flutter recurrence within 30 days |
| Procedural data | During Procedure | Ablation parameters, including: * Total RF ablation time * Temperature * Contact Force Procedural time Total fluoroscopy time |
Outcome results
None listed