ACT Catheter System in Atrial Flutter, Advanced Cardiac Therapeutics: CE Trial Clinical Study

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

1. Suitable candidate for catheter non-emergent intra-cardiac mapping and ablation.
2. Eighteen (18) to seventy five (75) years of age
3. Signed Informed Consent

Exclusion Criteria

1. Intracardiac thrombus, tumor or other abnormality that precludes catheter introduction and placement
2. Severe cerebrovascular disease or history of cerebrovascular event (within 1 month)
3. Patients with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) 3 with a GFR <= 29. This is calculated as follows for males:;GFR = (140 - age) x weight x .85 (for females)
PCr x 72;where age is specified in years, weight in kg, and PCr is Serum Creatinine in
Mg /dL Female GFR is reduced by 15% of the above calculated value for
males.
4. Active gastrointestinal bleeding
5. Active infection or fever (> 100.5 F/38 C)
6. Sepsis
7. Cardiac surgery within the past two months
8. Short life expectancy (< 1 yrs) due to other illnesses, such as cancer or pulmonary, hepatic, or renal disease
9. Significant anemia (hemoglobin < 8.0 mg / dL)
10. Severe uncontrolled systemic hypertension (systolic press. > 240 mm Hg within the last 30 days)
11. Documented anaphylaxis during previous exposure to angiographic contrast media
12. Uncontrolled congestive heart failure (NYHA Class III or IV)
13. Unstable angina or acute myocardial infarction within the past three months
14. Bleeding, clotting disorders, or known thrombosis
15. Peripheral vascular disease
16. Uncontrolled diabetes
17. Women who are pregnant and not willing to use contraception for the duration of the study, 30 days
18. Active participation in another investigational protocol
19. Unable or unwilling to take anti-coagulants
20. Unwilling or unable to comply with any protocol or follow up requirements

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objectives:<br /><br>The primary objective of this study is to assess the safety and performance of<br /><br>the ACT Catheter for the diagnosis and treatment of atrial flutter.<br /><br>The primary endpoints are defined by the following:<br /><br><br /><br>Safety: Acute Safety of the ACT Catheter will be evaluated by the absence of<br /><br>serious adverse events or serious adverse device effects during the time of the<br /><br>procedure and within seven (7) days afterwards.<br /><br><br /><br>Acute Ablation Performance: Ablation of atrial flutter with demonstration of<br /><br>block or isolation of signals confirmed after delivery of the ablation<br /><br>treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objectives:<br /><br>The secondary objectives of this study are to assess the:<br /><br>- manipulation and precise control of the device when used for mapping<br /><br>- Chronic safety of the device.<br /><br><br /><br>The secondary endpoints are defined by the following:<br /><br><br /><br>Mapping and Manipulation Performance: Evaluation of performance is the ability<br /><br>of the physician to navigate to anatomical targets and the ability to create an<br /><br>electroanatomic map relevant to the procedure.<br /><br><br /><br>Chronic Safety Evaluation: Chronic safety evaluation at 30 days of the<br /><br>procedure as evidenced by adverse events and adverse device effects</p><br>