The objective of this study is to evaluate the efficacy, safety and efficiency of RF ablation when guided by the CARTO® 3 System (using the THERMOCOOL® Catheter and LASSO® Circular Mapping Catheter) compared to fluoroscopy-guided RF ablation (using…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints supporting the objective are:
Efficacy: Freedom from documented AF/AT recurrences without new AADs through 1
year follow-up
Safety: Incidence of PV Stenosis (number of PVs with a reduction in diameter >=
50% at 6 months compared to baseline per CT or MRI)
Efficiency: Total procedure time (minutes from introduction of first catheter
to withdrawal of last catheter)
Secondary outcome
Efficacy:
1. Acute procedural success (% of subjects with confirmed entrance block at the
end of the ablation procedure)
2. Repeat ablation procedures for AF/AT recurrences through 1 year follow-up
3. Freedom from documented AF/AT recurrences without AAD(s)
4. Freedom from documented AF/AT recurrences with AAD(s)
5. Freedom from documented AF/AT recurrences after more than one ablation
procedure
6. Freedom from documented AF recurrences without AADs
7. Freedom from documented AF recurrences with AAD(s)
8. Freedom from documented symptomatic AF/AT recurrences without AAD(s)
9. Freedom from documented symptomatic AF/AT recurrences with AAD(s)
Safety:
1. Incidence of any procedure-related and/or device-related adverse events
occurring during the study
2. Incidence of any catheter-related adverse events occurring during the study
3. Total Fluoroscopy exposure time from time point of first catheter inserted
until last catheter removed (cumulative time including both fluoroscopy and
cine-fluoroscopy times; minutes)
4. Total Fluoroscopy Dose-Area Product (DAP) (Gy.cm²) / Source Intensifier
Distance
5. Incidence of any phrenic nerve paralysis
6. Incidence of any symptomatic Transient Ischemic Attack (TIA) or
Cerebrovascular Accident (CVA)
Efficiency:
• Number of mapping and ablation catheters used per subject
Health Economics (HE) Outcomes:
1. Quality of Life (SF-36®) and Atrial Fibrillation Symptom Frequency and
Severity Checklist assessment at 3, 6, and 12 months compared to baseline
2. Total procedure hospital visit and ablation procedure costs
3. Total number of initial or prolonged hospitalizations and unscheduled
arrhythmia-related health care provider visits (including emergency department
visits).
Background summary
Atrial fibrillation (AF) is the most common sustained arrhythmia in man. At
any time it affects 0.4% to 1% of the general population and increases in
prevalence with age to 8% in those older than 80 years. Different technologies
have been developed and are currently being used to achieve PVI, including the
NAVISTAR® THERMOCOOL® Catheter (Biosense Webster, Inc), which is an irrigated
tip ablation catheter. This catheter was evaluated in a randomized, controlled
clinical trial in combination with the CARTO® EP Navigation system (Biosense
Webster Inc) and represents a major advancement in the field of ablation
catheters. Available for commercial use in EU since 1998, the NAVISTAR®
THERMOCOOL® Catheter is the first ablation catheter to receive Food and Drug
Administration (FDA) approval for the treatment of drug refractory recurrent
symptomatic PAF (February 2009). More recently, the Pulmonary Vein Ablation
Catheter® (PVAC®) (Medtronic) has been developed for the treatment of atrial
fibrillation and has been commercially available in EU since 2006. The PVAC®
is a circular, decapolar mapping and ablation catheter with a 25-mm-diameter
array at the distal portion. However, there are some important differences in
the technology and design of both catheters that have the potential to impact
efficacy, safety and efficiency of RF ablation treatment.
Currently, the THERMOCOOL® Catheter with the CARTO® 3 System is widely used for
treating PAF, whereas the PVAC® has been recently introduced as an alternate
mapping and ablation catheter; however, well-controlled studies are needed to
compare the efficacy, safety and efficiency of the PVAC® with other standards
of care. To evaluate differences between the THERMOCOOL® Catheter and PVAC®,
these devices should be compared in a randomized, controlled clinical study.
Study objective
The objective of this study is to evaluate the efficacy, safety and efficiency
of RF ablation when guided by the CARTO® 3 System (using the THERMOCOOL®
Catheter and LASSO® Circular Mapping Catheter) compared to fluoroscopy-guided
RF ablation (using the PVAC®) in patients undergoing treatment for symptomatic
PAF.
Study design
A Prospective, Multi-center, Randomized (2:1), Controlled, Two-arm, Unblinded
Clinical Study
Intervention
Eligible subjects who sign the study informed consent form will be randomized
into one of two study arms:
THERMOCOOL® Group: RF ablation to achieve PVI using the CARTO® 3 System,
THERMOCOOL® Catheter, and LASSO® Circular Mapping Catheter.
PVAC® Group: RF ablation to achieve PVI using fluoroscopy and the PVAC®.
Study burden and risks
Burden:
The ablation procedures and follow-up schedule do not or only slighly deviate
from the standard of care, resulting in limited additional burden and
inconvenience for the patients participating in this research. The following
lists the assessments planned in this study:
- Clinic visits prior to the ablation, at time of study procedure, at 3, 6, 9
and 12 months follow-up
- Transthoracic Echocardiography before the ablation procedure
- Transesophageal Echocardiography before the ablation procedure
- SF-36 questionnaire at baseline, 3, 6 and 12 months
- Atrial Fibrillation Symptom and severity Checklist at baseline, 3, 6 and 12
months
- Computed Tomography or Magnetic Resonance Imaging at baseline and at 6 months
- Transtelephonic Monitoring in month 5, 6, 11, and 12 of follow-up
Risks:
RF catheter ablation has been used for nearly two decades, and the risks and
complications are well understood. The use of non-irrigated and
saline-irrigated ablation catheters is routine for many PAF ablation
procedures. No additional risks are anticipated for subjects enrolled in this
study compared to subjects undergoing ablation of symptomatic PAF outside of
the study (protocol section 12 Risk management).
Potential benefits:
The direct benefit for patients undergoing RF catheter ablation is the
potential elimination of AF episodes. It is furthermore expected that quality
of life will improve and less frequent hospitalization will be needed. The
information gained from the conduct of this study may benefit patients with AF
by improving future treatment modalities.
161 H drève Richelle
1410 Waterloo
BE
161 H drève Richelle
1410 Waterloo
BE
Listed location countries
Age
Inclusion criteria
Patients with PAF who have had two (2) symptomatic PAF episodes in the six (6) months prior to randomization, and who are selected for catheter ablation for the treatment of their AF. Additionally patients with recurrent AF with episodes up to 30 days with sinus rhythm maintained for more than one week following cardioversion and who require PVI only for the treatment of their AF. AT least one AF episode should be documented either on ECG, TTM, HM or telemetry strip.
Exclusion criteria
1. Longstanding persistent atrial fibrillation
2. Patients with a history of any atrial flutter requiring ablation in the right atrium during the study procedure
3. Patients in whom sinus rhythm was maintained for less than 1 week after electrical cardioversion
4. Previous ablation for AF
5. LA size > 55 mm
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 | NL32380.060.10 |