RIght VERsus LEFT study: treatment of paroxysmal atrial fibrillation in patients with sick sinus syndrome: Right atrial stimulation versus left atrial stimulation

ISRCTN	ISRCTN65911661
DOI	https://doi.org/10.1186/ISRCTN65911661
Secondary identifying numbers	NL38970.078.12

Submission date: 11/06/2013
Registration date: 08/07/2013
Last edited: 17/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Natasja de Groot
Scientific

's Gravendijkwal 230
Department of Cardiology
Erasmus MC - Thorax Center
room Ba 579
Rotterdam
3015 CE
Netherlands

Phone	+31 10 7034479
Email	t.ramdjan@erasmusmc.nl

Study information

Study design	Multicenter randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	RIVERLEFT
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/11/2012
Completion date	01/11/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	572
Key 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
Key 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
Date of first enrolment	01/11/2012
Date of final enrolment	01/11/2017

Locations

Countries of recruitment

Netherlands

Study participating centre

's Gravendijkwal 230

Rotterdam
3015 CE
Netherlands

Sponsor information

Erasmus Medical Center (Netherlands)
Hospital/treatment centre

c/o F. Zijlstra, MD, PhD
Thoraxcenter, Department of Cardiology
's Gravendijkwal 230
room Ba 593
Rotterdam
3015 CE
Netherlands

Website	http://www.erasmusmc.nl
"ROR"	https://ror.org/018906e22

Funders

Funder type

Other

Rijnmond Society of Cardiology (Cardiologen Club Rijnmond) (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	17/11/2014		Yes	No

Editorial Notes

17/12/2020: Internal review.