Plain English Summary
Background and study aims
When the heart beats, the heart muscle contracts (pulls inwards) in preparation for pumping blood around the body. The contractions are produced by electrical pulses. These are generated by a group of specialised cells known as the sinoatrial node (SA node). In sick sinus syndrome, the SA node no longer works as it should. This can lead to an abnormally slow heartbeat, an abnormally fast heartbeat or, in some cases, a combination of both. To our knowledge, the incidence of paroxysmal atrial fibrillation (a heart condition that causes an irregular and often abnormally fast heart rate which comes and goes and usually stops within 48 hours without any treatment) in patients with sick sinus syndrome is unknown. The number of atrial fibrillation (AF) episodes in sick sinus syndrome patients may be reduced by pacing in the atria (placing pacemaker which sends regular electrical pulses that help keep the heart beating regularly). Preventive pacing inhibits AF by averting sinus bradycardia (slow heartbeat) or by suppressing premature beats. The objectives of the study are:
1. To determine the effects of the pacing site on prevention of AF episodes
2. To examine the relationship between the pacing site, reduction of AF episodes, quality of life, heart failure, number of cardioversions [medical procedure by which an abnormally fast heart rate (tachycardia) or cardiac arrhythmia is converted to a normal rhythm], frequency and duration of hospital admission, AF progression and cardiac death.
3. To study electrical remodeling by analyzing characteristics of AF episodes obtained from continuous cardiac monitoring of atrial rhythm.
Who can participate?
Male and female, 18 years old or older patients with the sick sinus syndrome and paroxysms of AF will be included.
What does the study involve?
Patients of the participating hospitals will be recruited at the department of cardiology. The investigator is responsible for patient selection and appropriate inclusion. Each patient, prior to enrolling in the study, will be provided with a written explanation of the study procedure together with an assessment of risks in participating in the study. Written informed consent will be obtained from all patients. No patient will be enrolled if the consent form is not signed. The informed consent form will also be signed by the investigator. Patients will get a pacemaker implanted and the pacemaker lead will either be placed near the left atrium or in the right atrium (atrium - the four chambers in the heart). The follow up period is 36 months. At specific time intervals patient will be called by the investigator in order to check whether AF has occurred. Patients atrial rhythm will be continuously monitored.
What are the possible benefits and risks of participating?
Left atrial pacing has the potential benefit to prevent recurrence of paroxysmal AF. Besides pacemaker implantation risks in general, there are no specific study-related risks. Due to lead implantation in the atrium, rupture of this structure is possible.
Where is the study run from?
Participating medical centers in the Netherlands.
When is the study starting and how long is it expected to run for?
The study will take place between November 2012 and November 2017
Who is funding the study?
Rijnmond Society of Cardiology, Netherlands
Who is the main contact?
T.T.T.K. Ramdjan, PhD candidate in the Erasmus Medical Center Rotterdam, The Netherlands t.ramdjan@erasmusmc.nl
Trial website
Contact information
Type
Scientific
Primary contact
Dr Natasja de Groot
ORCID ID
Contact details
's Gravendijkwal 230
Department of Cardiology
Erasmus MC - Thorax Center
room Ba 579
Rotterdam
3015 CE
Netherlands
+31 10 7034479
t.ramdjan@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NL38970.078.12
Study information
Scientific title
RIght VERsus LEFT study: treatment of paroxysmal atrial fibrillation in patients with sick sinus syndrome: Right atrial stimulation versus left atrial stimulation - a randomized controlled trial
Acronym
RIVERLEFT
Study hypothesis
In patients with sick sinus syndrome and paroxysmal atrial fibrillation, pacing from the left atrium is more effective than from the right atrium in preventing AF paroxysms.
Ethics approval
The study protocol was approved on October 16th 2012 by the medical ethics committee in the Erasmus Medical Center Rotterdam, The Netherlands, Ethics reference no: NL38970.078.12
Study design
Multicenter randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cardiology / preventive pacing / sick sinus syndrome
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).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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.
Follow up visits will be planned 1, 3, 6, 12, 18, 24, 30 and 36 months after pacemaker implantation.
Secondary outcome measures
Quality of life assessment will be performed at follow up visits 1, 3, 6, 12, 18, 24, 30 and 36 months after pacemaker implantation.
Overall trial start date
01/11/2012
Overall trial end date
01/11/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male and female, 18 years old or older
2. Written informed consent signed by patient
3. Sick sinus syndrome
4. Documented paroxysmal atrial fibrillation with a duration of less than 30 seconds in the past 6 months
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
572
Participant exclusion criteria
1. Life expectancy less than 5 years
2. Left ventricular ejection fraction of less than 40%
3. Congenital heart defects
4. Mentally unable to participate in the follow-up protocol
5. Physically unable to participate in the follow-up protocol
6. Malignancies
7. Chronic obstructive pulmonary disease (COPD)
8. GFR value of less than 30 ml/min or creatinine value of less than 250 umol/l
9. Participation in another investigational drug or device study
Recruitment start date
01/11/2012
Recruitment end date
01/11/2017
Locations
Countries of recruitment
Netherlands
Trial participating centre
's Gravendijkwal 230
Rotterdam
3015 CE
Netherlands
Sponsor information
Organisation
Erasmus Medical Center (Netherlands)
Sponsor details
c/o F. Zijlstra
MD
PhD
Thoraxcenter
Department of Cardiology
's Gravendijkwal 230
room Ba 593
Rotterdam
3015 CE
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Rijnmond Society of Cardiology (Cardiologen Club Rijnmond) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25403703