abnormal heart rythm atrial flutter
Conditions
Interventions
Prior to introducing the ACT Catheter into the patient, tranthoracic
echocardiography will be used to evaluate the patient for structural heart
damage and pericardial effusion. The ACT Catheter will
Sponsors
Advanced Cardiac Therapeutics, Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 100.5 F/38 C) 6. Sepsis 7. Cardiac surgery within the past two months 8. Short life expectancy ( 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objectives: The primary objective of this study is to assess the safety and performance of the ACT Catheter for the diagnosis and treatment of atrial flutter. The primary endpoints are defined by the following: Safety: Acute Safety of the ACT Catheter will be evaluated by the absence of serious adverse events or serious adverse device effects during the time of the procedure and within seven (7) days afterwards. Acute Ablation Performance: Ablation of atrial flutter with demonstration of block or isolation of signals confirmed after delivery of the ablation treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives: The secondary objectives of this study are to assess the: - manipulation and precise control of the device when used for mapping - Chronic safety of the device. The secondary endpoints are defined by the following: Mapping and Manipulation Performance: Evaluation of performance is the ability of the physician to navigate to anatomical targets and the ability to create an electroanatomic map relevant to the procedure. Chronic Safety Evaluation: Chronic safety evaluation at 30 days of the procedure as evidenced by adverse events and adverse device effects | — |
Countries
Netherlands
Outcome results
None listed