The purpose of this study is to confirm the Gen2 irrigated Ablation Catheter will perform as expected based upon the observed rates in the literature for effectiveness and safety for similar CE marked and commercially available irrigated and non-…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Acute Effectiveness (Technical Success) defined as:
• Achievement of pulmonary vein ostia isolation confirmed at least 30 minutes
following the last RF ablation for pulmonary vein isolation with the Gen2
catheter
Chronic Effectiveness (Clinical Success) defined as:
• Freedom from paroxysmal or persistent atrial fibrillation at 6 months
post-ablation in the absence of antiarrhythmic medication (Subjects maintained
on a prevously ineffective dose of class I or class III antiarrhythmic
medication will be evaluated for freedom from AF at 6 months post-ablation off
antiarrhythmic medication)
• Freedom from SAE (Safety Success) defined as: Use of the Gen2 Irrigated
Ablation Catheter does not result in unacceptable risk defined by specific
serious adverse events identified in the clinical literature review listed .
If any Unanticipated Adverse Device Effects (UADEs) or 3 SAE*s from the
CLINICAL LITERATURE IDENTIFIED SERIOUS ADVERSE EVENT LIST are recorded, the
study will be halted and deemed a failure.
Secondary outcome
None
Background summary
Catheter ablation is a standard treatment for cardiac arrhythmias. With
catheter ablation, a small part of the heart that is responsible for the
arrhythmia is heated and eliminated. This is done with radiofrequency current
that is delivered via the distal electrode of an ablation catheter. The heating
process can be monitored via a thermocouple in the ablation electrode. However,
many ablations in left ventricle and left atrium require the use of an
irrigated electrode that sprays saline during ablation to prevent blood clot
formation. This irrigation cools not only the blood around the electrode, but
also the electrode itself such that the electrode remains cool and the
thermocouple inside it can not be used to monitor tissue heating. This may lead
to ineffective applications that do not create large enough lesions, but it may
also lead to excessive heating that may cause serious complications. Recently,
Fred Wittkampf (UMC Utrecht, NL) and Hiroshi Nakagawa (Univ of Oklahoma, USA)
have invented an irrigated electrode that uses thermally insulated irrigation
channels. This allows monitoring of electrode temperature and thus tissue
heating during ablation.
St. Jude Medical has developed the Gen2 Irrigated Ablation Catheter, an
improved irrigated catheter with a 2.5mm tip which uses thermal insulated
irrigation channels that allow the electrode to heat up during the ablation
despite cooling of the surrounding blood. Small electrodes may produce
comparable lesions to 4mm conventional catheters at lower power and the smaller
electrode may additionally benefit the procedure by utilizing capabilities of
discrete mapping. Lesions produced with a smaller catheter may be independent
of tip orientation. These modifications have been extensively tested in bench
and animal experiments to demonstrate safety and determine optimal recommended
settings for electrode temperature and maximum radiofrequency power.
This study will confirm the effectiveness and safety of an improved irrigated
ablation catheter due to its ability to monitor the effect of the ablation with
greater precision.
Study objective
The purpose of this study is to confirm the Gen2 irrigated Ablation Catheter
will perform as expected based upon the observed rates in the literature for
effectiveness and safety for similar CE marked and commercially available
irrigated and non-irrigated RF ablation catheters as documented in the
Investigator Brochure.
Study design
This study is a prospective, non-randomised, confirmatory study of 103 subjects
at up to 2 investigational sites in which outcomes the effectiveness and safety
endpoints will be compared to previously reported results in the clinical
literature.
Intervention
The intervention is cardiac catheterization using an ablation catheter that is
slightly different from the catheter that is presently used in this patient
population.
Study burden and risks
All candidates for the study will have the usual standard of care pre-cardiac
catheterization exams and tests performed. The procedural intervention is the
institution*s standard of care for cardiac catheterization using the
investigational device (an irrigated ablation catheter that is slightly
different from that which is presently used in these patients). Follow up
visits will be per standard of care of the respective institutions. An
additional phone call will be done at 4 weeks (+/- 7 days) to schedule the
required tests and follow-up visit at 8 weeks post-procedure and to answer a
few questions to assess post-procedure adverse events, atrial flutter or
atrial fibrillation symptoms and antiarrhythmic medication. (See section 5.2,
page 14-19 for details).
14901 DeVeau Place
Minnetonka MN 55345
USA
14901 DeVeau Place
Minnetonka MN 55345
USA
Listed location countries
Age
Inclusion criteria
Be between eighteen and eighty years of age;
Be scheduled for an atrial fibrilation ablation procedure;
Be able to undergo contrast-enhanced MRI imaging;
Have a cardiac CT or MRI scan within a 6 months time window prior to the planned procedure ;
Be willing and able to sign the study specific consent form;
Be willing and able to fulfill study requirements (including study follow-up visits);
Have a negative pregnancy test for females in case of doubt about a possible pregnancy and
Have documented paroxysmal or persistent atrial fibrillation (by electrocardiogram (ECG); trans-telephonic monitor (TTM); Holter monitor or telemetry strip)
Exclusion criteria
Have evidence of or is currently receiving treatment for infection (local or systemic);
Have evidence of LA thrombus prior to procedure;
Be hypercoaguable (unable to tolerate heparin anticoagulation therapy) during the procedure;
Have history of embolic event(s). (e.g., cerebrovascular accident, pulmonary embolism, transient ischemic attack, etc.);
Have experienced a myocardial infarction <=3 months prior to the study procedure;
Have recent history (<=3 months) of cardiac surgery; including device implants (e.g. pacemaker, implantable cardiac defibrillator, etc.);
Have significant coronary heart disease or heart failure (i.e. unstable angina pectoris and/or uncontrolled congestive heart failure resulting in NYHA Class III or IV) at the time of enrollment, except in cases where the NYHA Class III diagnosis is due to sustained AFL with rapid ventricular response;
Have history of any previous cardiac ablation for atrial fibrillation;
Have prosthetic heart valve or valvular heart disease requiring surgical intervention;
Have a pacemaker or ICD leads in or around the coronary sinus or coronary vasculature;
Be awaiting cardiac transplant or other cardiac surgery within the following 12 months;
Have significant pulmonary disease, or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms;
Have any condition for which the investigator feels it is unsafe for the subject to undergo an invasive EP catherization;
Have any condition for which the subject*s life expectancy is less than 12 months and
Be currently participating in another investigational study.
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 | NL18099.041.08 |