- To determine the effects of the pacing site on prevention of AF episodes - To examine the relation between the pacing site, reduction of AF episodes, quality of life, heart failure, number of cardioversions, frequency and duration of hospital…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint of this study is development of paroxysmal atrial fibrillation
despite left or right atrial stimulation.
The follow up period is 36 months. At specific time intervals patient will be
called by the investigator in order to check whether atrial fibrillation has
occurred. Patients atrial rhythm will continuously be monitored by Home
Monitoring® supplied by the pacemaker manufacturer.
Secondary outcome
Quality of Life assessment will be performed at specific time intervals.
Background summary
Rationale:
The Sick Sinus Syndrome (SSS) is defined as an intrinsic, symptomatic form of
sinus node dysfunction.
It is caused by damage to either the sinus node itself, surrounding nerves and
ganglia or the atrial myocardial
by e.g. inflammation, fibrosis or fatty infiltration.
To our knowledge, the incidence of paroxysmal atrial fibrillation (PAF) in
patients with SSS is unknown.
It has been estimated that 40 to 50% of patients with a pacemaker have sinus
node disease.
Studies have reported various incidences (8.2% and 45.5%) of PAF in patients
with SSS.
Prescribed anti-arrhythmic drug therapy for PAF might induce bradycardia.
The number of AF episodes in SSS patients may be reduced by pacing in the
atria.
Preventive pacing inhibits AF by averting sinus bradycardia or by suppressing
premature beats.
In a recent pilot study, Breuls et al. demonstrated that left atrial
stimulation was more effective than right atrial stimulation in terms of
reduction of AF episodes and improvement in quality of life in SSS patients
with paroxysmal AF.
Hypothesis:
In patients with the Sick Sinus Syndrome or anti-arrhyhmic drugs-related
bradycardia, overdrive pacing from the left atrium is more effective than from
the right atrium in preventing AF paroxysms.
Study objective
- To determine the effects of the pacing site on prevention of AF episodes
- To examine the relation between the pacing site, reduction of AF episodes,
quality of life, heart failure, number of cardioversions, frequency and
duration of hospital admission, AF progression and cardiac death.
- To study electrical remodeling by analyzing characteristics of AF episodes
obtained from continuously cardiac monitoring of atrial rhythm.
Study design
This is a multi-center, randomized, prospective study and will be performed
between October 2014 and October 2019.
Patients of the participating hospitals will be recruited at the department of
cardiology.
When pacemaker implantation is indicated and paroxysms of atrial fibrillation
are documented, patients will be asked to participate in this study.
Intervention
Patients will get a pacemaker implanted and the pacemaker lead will either be
placed near the left atrium (coronary sinus) or in the right atrium (right
atrial appendage).
Study burden and risks
Besides pacemaker implantation risks in general, there are no specific study
related risks. Due to lead implantation in the coronary sinus, rupture of this
structure is possible. Therefore a pericardial puncture is slightly more
likely.
's Gravendijkwal 230
Rotterdam 3015CE
NL
's Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
Inclusion criteria
- Written informed consent signed by patient
- Sick Sinus Syndrome or anti-arrhythmic drug-induced bradycardia
- Documented paroxysmal atrial fibrillation with a duration of >= 30 seconds in the past 6
months
- 18 years old or older
Exclusion criteria
- Life expectancy of <= 5 years
- Left Ventricular Ejection Fraction of <= 40 percent
- Congenital Heart Defects
- Mentally unable to participate in the follow up protocol
- Physically unable to participate in the follow up protocol
- Malignancies
- Chronic Obstructive Pulmonary Disease (COPD)
- GFR value of <= 30 mL/min or Creatinine value of >= 250 umol/l
- Participation in another investigational drug or device 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 |
|---|---|
| ISRCTN | ISRCTN65911661 |
| CCMO | NL38970.078.12 |