To demonstrate the safety, feasibility and performance of the EnSite HD Grid Catheter mapping system for advanced high-density three-dimensional mapping in patients undergoing catheter ablation procedures for the treatment of non-paroxysmal atrial…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety Endpoint: the proportion of subjects who experience intra-procedure
and/or post-procedure serious adverse events within 48 hours from the mapping
procedure.
Feasibility Endpoints:
* Determination of atrial areas with fast and regular activities in the left
atrium will be summarized by the proportion of subjects with each of the
following arrhythmia location: coronary sinus, LA appendage, posterior wall,
roof, mitral isthmus, left superior pulmonary vein, right superior pulmonary
vein, left inferior pulmonary vein, right inferior pulmonary vein, septum, and
any other location that was mapped.
Performance Endpoints:
* Geometry creation will be assessed by:
o The HD Grid Catheter*s ability to be maneuvered to all desired anatomic
locations,
o The incidence of induced ectopic beats or other arrhythmias occurring during
HD Grid Catheter maneuvering,
o The HD Grid Catheters ability to contact cardiac tissue,
o Determination if field scaling is appropriate when using the HD Grid Catheter
o Geometry created with the HD Grid Catheter is comparable to the subjects
CT/MRI (if CT/MRI is available)
Secondary outcome
Feasibility endpoints:
* Determination of atrial areas with fast and regular activities in the right
atrium will be summarized by the proportion of subjects with each of the
following arrhythmia locations: anterior wall, appendage, posterior wall, roof,
septum, other. Additionally, the average (+/- standard deviation) of the cycle
length for each location will be summarized.
* Complex fractionated electrograms will be summarized as the proportion of
subjects in whom a complex fractionated electrogram (defined as electrograms
that have low peak-to-peak amplitude and a cycle length of * 120 ms) was
identified.
* Consistent direction of wave front propagation will be summarized by the
average and standard deviation of the number of map points, the conduction
velocity and activation duration.
Performance endpoints:
* Map repeatability will be characterized by evaluating substrate conduction
velocity maps created using the HD Grid Catheter mapping system pre-ablation
compared to repeat pre-ablation.
* Demonstrate that the post-ablation map created with the HD Grid Catheter
shows a change corresponding to the ablation result (i.e. sinus rhythm)
* The HD Grid Catheter electrogram signals will be assessed by:
o The proportion of electrograms collected with the HD Grid Catheter that have
better quality/less noise than electrograms collected with the ablation
catheter at the same selected cardiac location
o The proportion of electrogram wave form traces from the HD Grid Catheter that
could be used to help diagnose the subject
Other secundairy endpoints
* Total mapping time * retrospective analysis
* Number of map points collected * retrospective analysis
* Number of RF ablations * from the Ampere generator * retrospective analysis
* Total RF application time * from the Ampere generator * retrospective analysis
* Occurrence of repeat ablations (incidence and time from index procedure)
* Incidence of all SAEs up to and including the 6 month follow-up visit as
adjudicated by the Clinical Events Committee (CEC)
* Percentage of subjects free of symptomatic and/or asymptomatic episodes of
study arrhythmia lasting longer than 30 seconds at 6 month follow-up visit (use
of a previously ineffective drug does not constitute treatment failure)
* Percentage of subjects free from any arrhythmia lasting longer than 30
seconds at 6 month follow-up visit (use of a previously ineffective drug does
not constitute treatment failure)
* EQ5D Quality of Life Assessment (Enrollment/Baseline, 30 days, 3, and 6
months)
* AFEQT Quality of Life Assessment for AF subjects (Enrollment/Baseline, 30
days, 3, and 6 months)
Background summary
Catheter ablation is an established treatment option for patients with atrial
fibrillation (AF) and left atrial tachycardia (AT). Catheter ablation for
non-paroxysmal AF is more complex as triggers, if present at all, are not
immediately apparent, but the abnormal atrial substrates are the likely
predominant mechanisms.10-12 Additional catheter ablation strategies targeting
for atrial substrate modification have been introduced. The common strategies
involve either application of empirical linear lesion sets in the atrial areas
or ablation of atrial areas with complex fractionated atrial electrograms in
addition to pulmonary vein isolation. Nevertheless, the corresponding success
rates in long-term sinus rhythm maintenance are modest.
Non-paroxysmal AF and left AT are characterized by fast and regular atrial
activities, complex fractionated atrial electrograms, consistent direction of
wave front propagation, and low peak-to-peak voltage.2-3, 5, 13-21 Advanced
high-density three-dimensional catheter mapping strategies to target the
evaluation of these characteristics and mechanisms responsible for the AF and
left AT, identification of atrial areas with low peak-to-peak voltages and
determination of the *critical* atrial targets for catheter ablation during the
procedures would be essential.
In this clinical evaluation a new high density 3 dimensional catheter mapping
system will be tested in subjects who are indicated to get a catheter ablation
procedure for non-paroxysmal AF.
Study objective
To demonstrate the safety, feasibility and performance of the EnSite HD Grid
Catheter mapping system for advanced high-density three-dimensional mapping in
patients undergoing catheter ablation procedures for the treatment of
non-paroxysmal atrial fibrillation (AF) or left atrial tachycardia (AT)
Study design
This is a prospective, single-arm, multi-center clinical investigation.
Intervention
Catheter ablation
Study burden and risks
There is minimal to no additional risk associated with participation. The
participants do have to come back to the outclinic for two additional follow up
visits at 30 days and 3 months in addition to the normal 6 months follow up
visit. And they will have to fill out 2 QoL questionnaires at each follow up
visit.
The use of HD Grid mapping prior to the ablation procedure might possibly lead
to a better treatment result.
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Listed location countries
Age
Inclusion criteria
1. Presence of non-paroxysmal atrial fibrillation (AF) or left atrial tachycardia (AT) referred for catheter ablation
2. Age of 18 years of age or older at time of Enrollment
3. On continuous anticoagulation (INR 2-3) for >4 weeks prior to the ablation
4. Able and willing to provide written informed consent to participate in this clinical investigation
Exclusion criteria
1. Secondary atrial fibrillation (AF)
2. Presence of a prosthetic valve(s) or hemodynamically significant valvular heart disease as determined by Study Investigator
3. Active systemic infection (e.g. sepsis)
4. Presence of left atrial thrombus (i.e., positive TEE) or myxoma, or interatrial baffle or patch via the transseptal approach
5. Contraindication to systemic anticoagulation (i.e., heparin, warfarin, or a direct thrombin inhibitor)
6. History of cerebrovascular accidents (Stroke, TIA)
7. Previous myocardial infarction, unstable angina pectoris or coronary artery by-pass <180 days at Enrollment or cardiovascular intervention expected in the 180 days post-Enrollment
8. Left atrial size >55mm
9. NYHA functional class III or IV heart failure
10. Left ventricular ejection fraction <35%
11. Uncontrolled Hyperthyroidism
12. Pregnant or of childbearing potential and not using adequate contraceptive methods or nursing
13. Participating in another clinical investigation that may confound the results of this clinical investigation
14. Life expectancy less than 12 months, as determined by Study Investigator
15. Severe clinical condition (e.g. active carcinoma) that, in the opinion of the Study Investigator, excludes the participation in the 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 | NL59389.058.16 |