The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF) ablation after, and the utility of electroanatomical mapping with the Advisor* HD Grid Mapping Catheter, Sensor Enabled* (hereafter called *HD Grid*) and…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To quantify and characterize the acute- and long-term success rate of RF
ablation after electroanatomical mapping with HD Grid, the following will be
summarized:
* Rate of acute success defined as the proportion of subjects who receive HD
Grid mapping and RF energy delivery resulting in acute termination of clinical
arrhythmia.
* Rate of long-term success defined as the proportion of subjects who receive
HD Grid mapping and RF energy delivery with the following pre-defined
procedural endpoints:
Persistent AF :
o freedom from all atrial arrhythmias (AF/AFL/AT) greater than 30 seconds (as
documented by 48-hr Holter at 12-month follow-up) and new or increased dose of
class I/III antiarrhythmic drug (AAD).
o freedom from all atrial arrhythmias (AF/AFL/AT) greater than 30 seconds (as
documented by 48-hr Holter at 12-month follow-up) on or off class I/III AAD.
VT :
o freedom from recurrence of sustained monomorphic VT and new or increased dose
of class I/III AAD at 6-month follow-up
o freedom from recurrence of sustained monomorphic VT on or off class I/III AAD
at 6-month follow-up.
Secondary outcome
The second objective is to quantify and characterize the use of HD Grid and
EnSite Precision with HD Wave in the electroanatomical mapping of PersAF or VT
in real-world clinical settings. This will be done through a summary of the
following:
Use of HD Grid and EnSite Precision with HD Wave will be quantified and
characterized through the summary of the following:
* Overall procedure time: defined as time from initial catheter insertion to
final catheter removal.
* Radiofrequency (RF) time: defined as duration of time RF energy is delivered
* Fluoroscopy time: defined as total time subject is exposed to fluoroscopy
* Mapping time associated with mapping arrhythmia:
* Number of mapping points collected:
* Number of mapping points used:
* Number of used mapping points per minute:
* Substrate characteristics identified:
* Ablation strategy(s) used:
* Role of HD Wave map relative to along-the-spline map in ablation strategy
decision: as assessed by physician survey comparing maps generated with HD Wave
electrode configuration to along-the-spline electrode configurations.
* Maneuverability of HD Grid catheter:
* HD Grid electrogram quality relative to ablation catheter electrograms: as
assessed by physician survey
Background summary
Atrial Fibrillation (AF) is a supraventricular arrhythmia characterized by
rapid and irregular activation in the atria, and, when maintained greater than
seven days, is known as Persistent AF (PersAF). Patients with PersAF have an
increased risk of stroke and are likely to develop life-threatening problems
such as tachycardia-induced cardiomyopathy and congestive heart failure which
can increase mortality. Restoration and maintenance of sinus rhythm in these
patients may confer mortality benefit.
Sustained monomorphic VT is a cardiac arrhythmia emanating from the ventricles
at a rate greater than 100 bpm that is sustained longer than 30s or requires
intervention due to hemodynamic instability. Sustained VT is associated with
increased mortality risk including risk of sudden cardiac death.
Catheter ablation is an established treatment option for PersAF and VT.
Ablation strategies target the pathogenic mechanisms that initiate and
perpetuate abnormal electrical activity within the heart including abnormal
substrate. However, identifying and eliminating the pathogenic mechanisms is
not straightforward.
Recent advancements in high-density three-dimensional catheter mapping
strategies enable the evaluation of such electrophysiologic characteristics
that are used for identifying the mechanisms responsible for PersAF and VT.
Identification of electrophysiological characteristics depends on the ability
of mapping catheter electrodes and electrode pair electrograms to detect
voltage characteristics.
Accurate electrogram depiction of underlying substrate is limited by adequate
bipole orientation which can be challenging to achieve with traditional linear
mapping catheters. The Advisor* HD Grid, Sensor Enabled* (HD Grid) diagnostic
mapping catheter with equispaced multipolar grid electrodes provides known
bipole spacing in orthogonal directions, thereby providing the ability to
discriminate voltage differences in two directions for enhanced directionality
and amplitude detection. This is done by using the HD Wave electrode
configuration with AutoMap best duplicate enabled during electroanatomical map
creation. It is hypothesized that the use of HD Wave mapping will allow
high-resolution substrate identification, but the impact of this mapping
catheter and configuration on the subsequent ablation strategy used by
physicians remains unknown and is therefor investigated.
Study objective
The aim of this study is to quantify and characterize the outcomes of
radiofrequency (RF) ablation after, and the utility of electroanatomical
mapping with the Advisor* HD Grid Mapping Catheter, Sensor Enabled* (hereafter
called *HD Grid*) and EnSite Precision* Cardiac Mapping System (SV 2.2 or
higher, hereafter called *EnSite Precision*) with HD Wave Vmax voltage mapping
(hereafter called *HD Wave*) in subjects with PersAF or VT in real-world
clinical settings. This will be completed through the assessment of two main
objectives which are as follows:
Outcomes Objective:
The first objective is to quantify and characterize the acute- and long-term
success rate of RF ablation after electroanatomical mapping with HD Grid and
EnSite Precision with HD Wave in subjects with PersAF or VT.
Utility Objective:
The second objective is to quantify and characterize the use of HD Grid and
EnSite Precision with HD Wave in the electroanatomical mapping of PersAF or VT
in real-world clinical settings.
Study design
This is a prospective, non-randomized, multicenter observational study.
Study burden and risks
The risk of the participation to the study is minimal. The burden is limited to
answering the 2 questionnaires at different visits (baseline, 6 months follow
up and 12 months follow up. The use of the HD Grid mapping catheter is an
additional procedure for patients participating in this study. The HD Grid
mapping is no standard of care treatment. The holterrecording with AF patients
will be longer (48h) than in the normal standard of care(24h).
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Listed location countries
Age
Inclusion criteria
1. Subject must provide written informed consent for study participation and willing and able to comply with the protocol described evaluations and follow up schedule.
2. Over 18 years of age
3. Indicated for cardiac electroanatomical mapping and RF ablation procedure to treat PersAF or VT
4. Subject is diagnosed with either PersAF OR VT as defined by:
a. Persistent AF <= Documented symptomatic persistent AF defined as continuous atrial fibrillation that is sustained beyond 7 days but less than 12 months
b. VT <= Sustained monomorphic ventricular tachycardia with record of VT event within last 6 months and history of prior myocardial infarction
Exclusion criteria
1. Life expectancy less than 12 months
2. Women who are pregnant or nursing
3. Known intracardiac thrombus or myxoma verified within 48 hours of index ablation procedure
4. Myocardial infarction (MI) or unstable angina, or previous cardiac surgery within 60 days of index ablation procedure
5. Percutaneous coronary intervention (PCI) within 30 days of index ablation procedure
6. Documented cerebroembolic event within the past 12 months (365 days)
7. History of valve repair, presence of a prosthetic valve, or severe mitral regurgitation thought to require valve replacement or repair within 12 months
8. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
9. Current acute illness or active systemic infection or sepsis
10. Currently enrolled in another clinical study that could confound the results of this study
11. Any cause for contraindication to ablation procedure or systemic anticoagulation
12. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator*s opinion, could limit the subject*s ability to participate in the clinical study or to comply with follow-up requirements, or impact the scientific soundness of the clinical study results.
13. Vulnerable patient or individuals whose willingness to volunteer in a study, in the judgement of investigator or public authorities, could be unduly influenced by lack of or loss of autonomy
14. Indication-specific exclusion criteria including:
a. PersAF:
i. PersAF felt to be secondary to electrolyte imbalance, uncontrolled thyroid disease, or reversible or non-cardiac cause.
ii. Prior catheter ablation for AF beyond pulmonary vein isolation
iii. LAD > 55 mm (parasternal long axis view)
iv. LVEF < 40%
v. Uncontrolled heart failure or NYHA function class III or IV
vi. Presence of implanted ICD/CRT-D
b. VT:
i. VT/VF thought to be from channelopathies
ii. Active ischemia or other reversible cause of VT
iii. Incessant VT at time of procedure
iv. Implanted with a ventricular assist device (VAD) (e.g. TandemHeart)
v. Chronic NYHA Class IV heart failure
vi.Ejection fraction < 15%
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
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 | NL68033.098.18 |