Verification of number of mode switches, Verification of undersensing of AFor other ATAs. Incidence of mode switches due to FFRW oversensing using Accent pacemaker in the most sensitive sensing setting(s)using the Optisense vrs Tendril lead
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Number of mode switches due to FFRW oversensing
• Number and duration of inappropriate modeswiches due to FFRW sensing during
sinus rhythm
• Number of episodes and total duration of paroxysmal AF and AT from Holter
recording
• Number of and total duration of undersensing of paroxysmal AF and AT in
pacemaker.
• Number of 2:1 lock-in during AT or Aflutter.
Secondary outcome
• Sensing of myopotentials
Background summary
For patients with indications for chronic cardiac pacing who suffer from atrial
arrhythmias, the pacemaker therapy is based on data about these arrhythmias
stored in the pacemaker memory. If therapy is based on PM data, the automatic
mode switching (AMS) algorithm has to function reliable for the identification
of the onset and offset as well as the incidence and duration of paroxysmal
atrial rhythm disturbances such as AF and AT (ATA's). The reliability of AMS
depends on adequate sensing and discrimination of atrial potentials.
Inappropriate mode switching during the detection of ATAs is caused by sensing
of far field signals most frequently by sensing the far field R-wave (FFRW)
signals. The lead characteristics have proved to be a determining factor in the
sensing of the FFRW. A shorter spacing between the dipole (tip to ring) of a
bipolar lead makes the pacemaker system less susceptible to FFRW sensing. A
recent experimental study*s demonstrated that FFRW can be reduced effectively
without loss of P wave amplitude, i.e. with maintenance of the P-wave/FFRW
ratio, with a novel lead designed with a short tip ring distance of 1.1 mm.
Consequently, a lead with a similar tip-ring distance is now commercially
available and approved for clinical use and will be compared to a more
conventional lead in its ability to avoid oversensing of FFRW's while
preventing undersensing of atrial fibrillation. In other words the new lead is
less sensible to the disturbing FFRW signals but can it still recognize AF?
Study objective
Verification of number of mode switches, Verification of undersensing of AFor
other ATAs. Incidence of mode switches due to FFRW oversensing using Accent
pacemaker in the most sensitive sensing setting(s)using the Optisense vrs
Tendril lead
Study design
Prospective, singleblind, 1:1 randomised study comparing a group with Optisense
leads with a group with Tendril leads.
Intervention
Implantation of an Accent pacemaker according to the routine implantation
procedure for pacemakers.
Study burden and risks
There is a limited chance of experiencing palpitations during the first 3 day
Holter recording due to the sensitive settings of the pacemaker. The burden of
these palpitations will be limited.
Standaardruiter 13
3905 PT Veenendaal
NL
Standaardruiter 13
3905 PT Veenendaal
NL
Listed location countries
Age
Inclusion criteria
• Patients with class I or II pacing indications for Sick Sinus Syndrome with suspected paroxysmal atrial tachyarrhythmias over the 6 months.
• Signed informed consent
• Age >18 yrs
Exclusion criteria
• Left Ventricular Ejection Fraction <35% (last 6 months)
• Severe valvular heart disease
• Congestive heart failure - NYHA class III - IV
• Angina Pectoris class III-IV
• Hypertrophic Cardio-myopathy
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 |
|---|---|
| ClinicalTrials.gov | NCT01074749 |
| CCMO | NL29728.100.09 |