This study is intended to assess the safety and performance of the ACT Catheter for ablation of right atrial isthmus dependent flutter, also known as typical atrial flutter.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
The ACT Catheter system consists of a manually steerable electrophysiology
catheter, with an integrated, irrigated tip for the radiofrequency ablation of
arrhythmias. Additionally the ACT Catheter system contains circuitry for
measuring the temperature at depth of the ablated tissue using microwave
radiometry and hooks up to an auxiliary device through a cable in order to
display this temperature at depth to the user.
Study objective
This study is intended to assess the safety and performance of the ACT Catheter
for ablation of right atrial isthmus dependent flutter, also known as typical
atrial flutter.
Study design
The ACT Catheter System trial is a prospective, multi-center, single arm study,
enrolling up to 30 subjects in Europe and New Zealand.
Patients with atrial flutter with indication for treatment with ablation
technique are considered as potential patient for the trial.
Individual subjects will be studied during mapping and ablation with acute 7
day follow-up. It is anticipated that enrolment and safety follow-up will take
approximately six weeks to complete. A chronic safety follow-up of 30 days will
be evaluated.
Intervention
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 then be manually
introduced and remotely navigated into the right and/or left atrium of the
heart. As appropriate, the catheter will be remotely navigated to physician
selected targets to create an electro-anatomical map and to ablate. With
mapping and ablation complete, the ACT Catheter will be removed and
tranthoracic echocardiography will be used to re-evaluate the patient for
structural heart damage and pericardial effusion. Alternatively, if preferred,
the physician can use a regulatory approved robotic system such as the Hansen
Medical Inc Robotic System for navigating the ACT Catheter during the
procedure.
Study burden and risks
Extensive in vitro bench and in vivo animal studies have been successfully
performed with the ACT Catheter and verification testing for the catheter has
been completed. The associated risks proposed in this study, are similar to
risks posed by other interventional, electrophysiological cardiac procedures.
The benefit to the subjects enrolled in this study is the potential for
improved judgement by the clinician due to the additional information provided
by the microwave radiometry functionality of the catheter.
1278 Glenneyre #139
Laguna Beach, CA92651
US
1278 Glenneyre #139
Laguna Beach, CA92651
US
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL33139.100.10 |