Cavotricuspid Isthmus Dependent Right Atrial Flutter Clinical Trial
Official title:
Evaluation of a Multi-Electrode Linear Type Ablation Catheter for Endocardial Ablation of Patients With Right Atrial Flutter
| Verified date | June 2015 |
| Source | Biosense Webster, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ministry of Health |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | May 2015 |
| Est. primary completion date | November 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | Miulli Hospital | Acquaviva Delle Fonti | Bari/Strada |
| Lead Sponsor | Collaborator |
|---|---|
| Biosense Webster, Inc. |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety | Incidence of early onset (within 7 days of ablation procedure) primary AEs | 7 Days | Yes |
| Primary | Acute performance | Acute procedural success as confirmed complete bidirectional conduction block across the CTI (assess =30 min following last RF application) | This outcome measure will be assessed during the procedure but after 30 minutes (or more) of the initial ablation | No |
| Secondary | Safety | Incidence of Serious Adverse Events during follow-up | Until one-month follow-up | Yes |
| Secondary | Acute Efficacy | Right atrial flutter recurrence within 30 days | Within 30 Days | No |
| Secondary | Procedural data | Ablation parameters, including: Total RF ablation time Temperature Contact Force Procedural time Total fluoroscopy time |
During Procedure | No |