To demonstrate that ventricular tachycardia (VT) ablation using the Niobe* ES system results in superior outcomes compared to a manual approach in subjects with ischemic scar VT in a low ejection fraction population.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Freedom from any recurrence of VT through 12 months.
Secondary outcome
2. Acute Success: Defined as non-inducibility of clinical VT and/or other
monomorphic VT, using typical stimulation protocol for induction, up to 3
extra-stimuli brought in to ventricular refractoriness at 2 drive cycle
lengths, in two sites).
3. Freedom from any VT at 1 year in a large scar subpopulation (defined as
patients with a scar total surface area > the median scar total surface area
for the total population as determined by electroanatomic mapping).
4. Procedure related major adverse events defined as death, cardiac tamponade,
stroke, and bleeding requiring surgical intervention through 48 hours
post-procedure, and progressive heart failure related to VT/VF recurrence
within 48 hours post-ablation.
5. Mortality rate through 12-months follow-up
Background summary
Ischemic cardiomyopathy (ICM) is a prevalent cardiac disease around the world.
ICM patients with history of myocardial infarction consist of a significant
population referred for ventricular tachycardia (VT) RF ablation. Catheter
ablation of VT is effective with recurrent sustained VT episodes and particular
useful in the patients with implanted defibrillators.
In contrast to conventional manual approach, magnetic navigation system (MNS)
offers remote guidance of ablation catheters during ablation for cardiac
arrhythmias, by navigating the magnetic-tipped catheter precisely to the
substrate targets. Recently, Bhaskaran et al (2015) reported that the latest
MNS platform, Niobe ES, could produce larger lesion dimensions compared to
manual approach in the presence of simulated wall motion in a bench-top model,
consistent with greater catheter stability. MNS has provided important clinical
advantages in safety due to the remote magnetic vector control, atraumatic
catheter design and less physical stress and radiation exposure for the
operator.
Numerous studies have revealed significant advantages, mainly for the ablation
of Non-Structural Heart Disease VT (NSHDVT) when compared to conventional
methods. A single center study with consecutive case series (2015) demonstrated
a better long-term outcome of MNS in a heterogeneous VT (ischemic mixed with
non-ischemic) cohort by the intention-to-treat analysis. Its better long term
outcome, more than 2 years, for the MNS group is likely linked to the higher
acute success rate. A possible explanation for the higher acute success in MNS
guided VT ablation is enhanced maneuverability and improved catheter stability
using the latest platform. However, despite these impactful reports in MNS
guided VT ablations, the superior outcome evidence in ischemic VT in MNS is
lacking from randomized study design prospective. It remains a major debate in
the VT ablation field.
Study objective
To demonstrate that ventricular tachycardia (VT) ablation using the Niobe* ES
system results in superior outcomes compared to a manual approach in subjects
with ischemic scar VT in a low ejection fraction population.
Study design
This study is a randomized, single-blind, prospective, multi-center post market
study. Patients will be enrolled and randomized 1:1. A total of 386 subjects
(193 per treatment group) will be randomized 1:1 between treatment with the
Niobe ES system and treatment via a manual procedure. Patients are to be
followed through 12-month follow-up (visits at 3 [remote visit allowed], 6, 9
[remote visit allowed] and 12 months).
Intervention
The ablation of ventricular arrhythmias is a standard treatment in specialized
hospitals. In this trial the patients will be randomized between two ablation
techniques; the conventional manual approach and the approach where the
ablation occurs by means of magnetical navigation where the catheters are
guided through magnets (MN, Magnet Navigation). MN exists for years already and
the Erasmus MC was one of the first centers to apply this technique. Over time
this technique has improved, amongst others the ability to guide the
catheters.
Study burden and risks
In essence the burden for the patient will not differ between the two
techniques. Prior to an ablation it is difficult to establish what the exact
time burden for the patient will be. The biggest risks for an ablation are
amongst others: thromboembolic complications, perforation and tamponade,
bleedings. In this research there are no other complication expected than
compared to the standard.
Forest Park Avenue 4320
St. Louis MO 63108
US
Forest Park Avenue 4320
St. Louis MO 63108
US
Listed location countries
Age
Inclusion criteria
1. Patient is 18 years of age or older;
2. Patient has provided written informed consent;
3. Patient has an implantable cardioverter defibrillator (ICD) previously implanted;
4. Drug refractory monomorphic VT;
5. Patient is a candidate for ischemic VT RF ablation;
6. Patient has had a myocardial infarction;
7. LVEF * 35%.
Exclusion criteria
1. Non-ischemic VT;
2. History of stroke within 1 month prior to enrollment;
3. Acute MI within 30 days prior to enrollment;
4. Unstable angina;
5. Cardiac surgery within 60 days prior to enrollment;
6. Patient is pregnant or nursing;
7. Limited life expectancy of 1 year or less (Subjects requiring LVAD/IABP intraprocedural support may be enrolled as long as life expectancy is at least 1 year following the ablation procedure.)
8. Patient is unable or unwilling to cooperate with the study procedures;
9.. Known presence of intracardiac thrombi determined by echocardiography;
10. Major contraindication to anticoagulation therapy or coagulation disorder;
11. Previous pericarditis or cardiac tumor;
12. Previous thoracic radiation therapy;
13. Any other reason the investigator considers the subject ineligible.
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 | NL57060.078.16 |