Primary Objective: • To contrast Coherent Mapping quality (electrograms per map) and noise assessment using Octaray (with TRUEREF technology) versus Pentaray catheter for left and right atrium.Secondary Objective(s): • To contrast the Coherent…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) number of electrograms per map;
2) voltage-based signal to noise ratio per map.
Secondary outcome
1) electrograms acquisition rate per map;
2) electrogram acquisition density;
3) number of electrograms acquired per beat;
4) the total ablation and fluoroscopy times per group;
5) acute mapping success per group
6) number of entrainments attempted and best post-pacing interval value at
ablation site per group, when available.
Background summary
Ablation of atrial tachycardia (AT) remains challenging even in the era of
sophisticated 3D mapping systems. Among others far-field signals and noise
remains an important issue hampering high-resolution mapping of complex ATs,
and adequately mapping AT is a time-consuming process. Possibly, the recently
developed Octaray catheter, which utilizes a non-contact central electrode and
more closely spaced electrodes may tackle these issues and improve the map
efficiency, quality and improve identification of the AT mechanism.
Study objective
Primary Objective:
• To contrast Coherent Mapping quality (electrograms per map) and noise
assessment using Octaray (with TRUEREF technology) versus Pentaray catheter for
left and right atrium.
Secondary Objective(s):
• To contrast the Coherent Mapping times using Octaray versus Pentaray
catheters for left and right atrium.
• To assess whether Octaray is more efficient/effective than Petaray in
identifying the critical components of the arrhythmia mechanisms and ablation
targets (acute success) using Coherent Mapping.
• To assess the radiofrequency applications/duration and fluoroscopy times in
patients with Octaray-based Coherent Mapping versus Pentaray-based Coherent
Mapping.
Study design
This is a randomized open-label trial including consecutive patients undergoing
ablation for atrial tachycardia of the left and right atrium. Half of the
eligible patients will be randomized to undergo Coherent Mapping with Pentaray
catheter first followed by Coherent Mapping with the Octaray catheter next. The
other half will undergo initial Coherent Mapping with the Octaray catheter
followed by Pentaray catheter. All study participants (N=60) will undergo the
Coherent Mapping with both catheters. Only the second map created with either
Octaray (active arm, N=30) or Pentaray (control arm, N=30) will be used for the
subsequent ablation procedure.
Intervention
Additional 3D Coherent map with Octaray catheter on top of the standard
Coherent map with Pentaray catheter.
Study burden and risks
The harms of the study are limited. The new catheter (Octaray) has similar
shape, is made from similar material and is similar in size as the standard
catheter (Pentaray), the only difference is the number of splines and
electrodes. The creation of two maps will increase the mapping time, but
because of more information provided by two maps, it is possible that the total
procedure time is similar or lower due to more precise/efficient ablation.
Changing the catheters may in theory increase the chance of air-embolism,
however in the hands of experienced operators the risks should be negligibly
small and catheter changing during such complex procedures are common practice.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
Adult patients planned for ablation of atrial tachycardia or atrial flutter.
Exclusion criteria
Individuals not able to provide informed consent for any reason including
language and metal disabilities.
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 |
|---|---|
| Other | Clinicaltrials.gov |
| CCMO | NL80780.078.22 |