Primary Objective: To evaluate the feasibility to obtain a stable position of a ring of stimulation electrodes on the interatrial septum.Secondary objective: *Localized Atrial Capture: evaluate if during the rapid pacing phase of the dual-stage…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To regard pacing site stability, the number of electrodes that are
successfully placed will be counted. For this purpose, the pacing threshold
must be less than 10mA at a pulse width of 1ms and no ventricular capture
should occur when stimulation occurs with twice the atrial pacing threshold.
Secondary outcome
To assess Localized Atrial Capture the following endpoints will be considered:
*The number of AF episodes in which local capture is recorded during atrial
septal stimulation in at least one of the electrode positions
*The number of electrodes for which local capture is determined using pacing
schemes with various pacing cycle lengths (PCL) for a duration of 10-30
seconds depending on when capture occurs, at the start of the scheme followed,
if feasible, by slow pacing for 1.5 s at 180% AFCL, initiated by a single
stimulus at 130% AFCL.
*The spatial extend of capture (assessed from the atrial electrograms recorded
from the multipolar right atrial catheter and the multipolar coronary sinus
catheter) to obtain local atrial capture obtained with septal pacing of AF,
will be assessed off-line after the study procedure.
To assess whether AF termination can be obtained using a dual-stage septal
pacing scheme, the surface ECG will be analyzed and the PCL and stimulation
current used, will be noted to measure the number of subjects in which the
pacing scheme successfully terminates the AF episode.
Background summary
The proof to treat atrial fibrillation (AF) with pacing is restricted. These
treatment are interesting because they are safe and not expensive.
With a computer model a pacing schedule is developed in which it is possible to
capture the AF in the local atria.
It was not possible to terminate the AF by stimulation with 1 electrode, but is
was possible with 4 electrodes.
This is also tested in pigs with positive results. Clinical studies show that
pacing on the septum is safe with 1 electrode. because the anatomy of the pigs
heart is different from humans, it could be that the optimal placing of the
catheter to the septum is not optimal for humans.
Also the safety of stimulation with 4 electrodes and the efficacy to obtain
capture and if feasible to terminate the algorhytm of AF needs to be
investigated.
Study objective
Primary Objective: To evaluate the feasibility to obtain a stable position of a
ring of stimulation electrodes on the interatrial septum.
Secondary objective:
*Localized Atrial Capture: evaluate if during the rapid pacing phase of the
dual-stage septal pacing scheme (rapid pacing followed by a step-wise
transition to slow-pacing) from multiple electrodes on the interatrial septum,
local atrial capture can be observed during atrial fibrillation.
*AF Termination Scheme: evaluate if AF termination can be obtained using a
dual-stage septal pacing scheme (rapid pacing followed by a step-wise
transition to slow-pacing) from multiple electrodes on the interatrial septum.
Study design
Non-randomized, non-controlled, acute, single-arm research study
Intervention
After the patient has undergone the ablation procedure, there is a waiting time
of half an hour. During this time we want to conduct the study. The patient
then already has monitor catheters in the right atrium and the coronary sinus
from the standard procedure. The septal catheter will be passed through the
septum through a puncture and placed against the left atrial septal wall.
1. In case the patient has sinus rhythm a test will be done whether the
placement of this catheter is stable. For this purpose, the pacing thresholds
and impedances will be tested.
Also a test will be done to confirm that no ventricle arrhythmia can be induced
during the pacing testing
Subsequently, atrial fibrillation will be induced by high frequency pacing.
The atrial fibrillation cycle length is then determined. Hereafter, it is
investigated if capture of atrial fibrillation occurs. This is investigated
per electrode and if all 4 electrodes are used at the same time.
The pacing scheme consists of a range of percentages of the atrial
fibrillation cycle length for 10-30 seconds until capture occurs, followed by a
stepwise transition to sinus rhythm via an atrial fibrillation cycle length of
130% and 180%.
2. In case the patient has atrial fibrillation, first a test will be done to
confirm that no ventricle arrhythmia can be induced during the pacing test.
After this the pacing tests will performed with multiple electrode
combinations. In case the pacing test does not stop the atrial fibrillation, a
cardio-version will be done so the patient will get a sinus rhythm. During
sinus rhythm the pacing thresholds and impedances will be tested.
Study burden and risks
The study procedure is performed during the half hour waiting time of the
standard procedure. A new pacing therapy is being developed to terminate AF.
There is no direct benefit for the subject. AF must be induced by high
frequency pacing and if the patient does not come out of it spontaneously and
also if the therapy appears to be ineffective, the patient will be cardioverted
during sedation.
Endepolsdomein 5
Maastricht 6229GW
NL
Endepolsdomein 5
Maastricht 6229GW
NL
Listed location countries
Age
Inclusion criteria
* Patient referred to the center to undergo ablation of the pulmonary vein using radiofrequency (initial AF ablation, or redo procedure).
* In case of paroxysmal AF the right atrium should be dilated as indicated by > 29 ml mm2 or the left atrium should be dilated as indicated by > 34 ml mm2.
* Patient is willing and able to cooperate with the study procedure .
* Patient is willing and able to cooperate with the study procedure.
* Patient is willing and able to sign provide the Informed Consent for their participation in the study.
Exclusion criteria
* Patients under 18 years or over 80 years old.
* Women who are currently pregnant or have a positive pregnancy test.
* Patients with an implantable cardiac device
Patients who already underwent an AF septal ablation procedure.
Design
Recruitment
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 |
|---|---|
| ClinicalTrials.gov | NCT03242941 |
| CCMO | NL61292.100.17 |