BradyarrhythmiaRIVELANCT01535404
Right Versus Left Apical Transvenous Pacing for Patients With Preserved Left Ventricular Systolic Function Study
A study testing Implantation procedure for a St-Jude Medical pacemaker system with right ventricular apex pacing and Implantation procedure for a St-Jude Medical pacemaker system with left ventricular apex pacing in people with Bradyarrhythmia, run by Haran Burri, MD at 6 sites in 2 countries.
Trial summary
The purpose of this study is to compare chronic (1-year) effects on left ventricular ejection fraction resulting from transvenous pacing of the right ventricular apex (RVA) versus the left ventricular apex (LVA) in patients with preserved or mildly reduced left ventricular systolic function (>= 45%). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradyarrhythmia
- What is being tested?
- Implantation procedure for a St-Jude Medical pacemaker system with right ventricular apex pacing and Implantation procedure for a St-Jude Medical pacemaker system with left ventricular apex pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jan 2012to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Requirement for ventricular pacing according to current guidelines (including chronic atrial fibrillation)
- Anticipated >=50% daily ventricular pacing
- LVEF >=45% as evaluated by 2D-echocardiography, 3D-echocardiography, magnetic resonance imaging or by radionuclide/contrast ventriculography
- Minimum age of 18 years, and at least 1 year life expectancy
Who cannot join
- Prior tricuspid valve replacement (annuloplasty is permitted)
- Intrinsic rhythm < 30bpm
- Patients with permanent atrial fibrillation who undergo ablation of the atrioventricular node.
- Echocardiographic window of insufficient quality for measuring LVEF
- Life expectancy of < 1year
- Pregnancy (women of childbearing potential will undergo pregnancy testing)
- Unable of unwilling to sign a patient informed consent form
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Switzerland5 sites
University Hospital of Basel
Basel, Canton of Basel-City, 4031
University Hospital Geneva
Geneva, Canton of Geneva, 1211
Kantonsspital Luzern
Lucerne, Canton of Lucerne, 6000
Cardiocentro Ticino (Lugano)
Lugano, Canton Ticino, 6900
Kantonsspital St-Gallen
Sankt Gallen, Canton of St. Gallen, 9007
Netherlands1 site
Cardiovascular Research Institute, University of Maastricht
Maastricht, 6229
About this study
Official title: Right Versus Left Apical Transvenous Pacing for Patients With Preserved Left Ventricular Systolic Function (RIVELA) Study
The purpose of this study is to compare chronic (1-year) effects on left ventricular ejection fraction resulting from transvenous pacing of the right ventricular apex (RVA) versus the left ventricular apex (LVA) in patients with preserved or mildly reduced left ventricular systolic function (>= 45%).
Read the detailed description
It is well established that chronic right ventricular apical pacing has an adverse effect on left ventricular systolic function. An alternative is pacing the left ventricular apex, which has shown more favourable results in terms of left ventricular pump function than the RVA in small series. The left ventricular apex may be paced via the coronary sinus tributary (e.g. in the anterior cardiac vein). Our study will compare effects of these two pacing sites on left ventricular ejection fraction measured by 3D-echocardiography.
- Conditions
- Bradyarrhythmia
- Being tested
- Implantation procedure for a St-Jude Medical pacemaker system with right ventricular apex pacing, Implantation procedure for a St-Jude Medical pacemaker system with left ventricular apex pacing
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation procedure for a St-Jude Medical pacemaker system with right ventricular apex pacingDevice
Implantation procedure for a St-Jude Medical pacemaker system with a transvenous ventricular and if applicable a right atrial lead
Implantation procedure for a St-Jude Medical pacemaker system with left ventricular apex pacingDevice
Implantation procedure for a St-Jude Medical pacemaker system with a transvenous left ventricular (coronary sinus) and if applicable a right atrial lead
| Study group | Role | What they receive |
|---|---|---|
| Right ventricular apex pacing | Active comparator | Not described Receives: Device: Implantation procedure for a St-Jude Medical pacemaker system with right ventricular apex pacing |
| Left ventricular apex pacing | Experimental | Not described Receives: Device: Implantation procedure for a St-Jude Medical pacemaker system with left ventricular apex pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in LVEF
Measured: baseline to one year
Secondary outcomes (8)
Change in left ventricular end-systolic and end-diastolic volumes
Measured: one year
Dyssynchrony evaluation during RV and LV pacing
Measured: one year
Change in tricuspid regurgitation severity, if any
Measured: one year
Change in mitral regurgitation severity, if any
Measured: one year
Incidence of device-related complications
Measured: one year
Success rate of autocapture algorithm for left-and right-ventricular pacing
Measured: one year
Mortality and all cause hospitalization
Measured: one year
Reduction of LVEF at 1 year compared to baseline according to the following pre-specified subgroups: a) initial LVEF, b) gender, c)etiology (coronary artery disease, nonischemic cardiomyopathy)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradyarrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haran Burri, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Sponsor-investigator, Haran Burri, MD, University Hospital, Geneva
- Investigators
- Haran Burri, Assoc. Prof., Principal investigator, University Hospital, GenevaAngelo Auricchio, Prof., Principal investigator, Fondazione Cardiocentro Ticino (Lugano)Christian Sticherling, Prof., Study chair, University Hospital of BaselPaul Erne, Prof., Study chair, Luzerner KantonsspitalPeter Ammann, PD Dr., Study chair, Cantonal Hospital of St. GallenFrits Prinzen, Dr., Study chair, Cardiovascular Research Institute, University of Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535404
- Sponsor's protocol ID
- CRM-CH-Riv01
- Acronym
- RIVELA
- Status last verified
- Oct 2014
- First submitted
- 10 Feb 2012
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right Versus Left Apical Transvenous Pacing for Patients With Preserved Left Ventricular Systolic Function (RIVELA) Study
- ClinicalTrials.gov ID
- NCT01535404
- Acronym / sponsor ID
- RIVELA / CRM-CH-Riv01
- Conditions
- Bradyarrhythmia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Haran Burri, MDUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- Jan 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 17 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare chronic (1-year) effects on left ventricular ejection fraction resulting from transvenous pacing of the right ventricular apex (RVA) versus the left ventricular apex (LVA) in patients with preserved or mildly reduced left ventricular systolic function (>= 45%).
Detailed description
It is well established that chronic right ventricular apical pacing has an adverse effect on left ventricular systolic function. An alternative is pacing the left ventricular apex, which has shown more favourable results in terms of left ventricular pump function than the RVA in small series. The left ventricular apex may be paced via the coronary sinus tributary (e.g. in the anterior cardiac vein). Our study will compare effects of these two pacing sites on left ventricular ejection fraction measured by 3D-echocardiography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right ventricular apex pacing | Active comparator | Device: Implantation procedure for a St-Jude Medical pacemaker system with right ventricular apex pacing |
| Left ventricular apex pacing | Experimental | Device: Implantation procedure for a St-Jude Medical pacemaker system with left ventricular apex pacing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Requirement for ventricular pacing according to current guidelines (including chronic atrial fibrillation)
- Anticipated >=50% daily ventricular pacing
- LVEF >=45% as evaluated by 2D-echocardiography, 3D-echocardiography, magnetic resonance imaging or by radionuclide/contrast ventriculography
- Minimum age of 18 years, and at least 1 year life expectancy
Key exclusion criteria (7 listed)
- Prior tricuspid valve replacement (annuloplasty is permitted)
- Intrinsic rhythm < 30bpm
- Patients with permanent atrial fibrillation who undergo ablation of the atrioventricular node.
- Echocardiographic window of insufficient quality for measuring LVEF
- Life expectancy of < 1year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation procedure for a St-Jude Medical pacemaker system with right ventricular apex pacingImplantation procedure for a St-Jude Medical pacemaker system with a transvenous ventricular and if applicable a right atrial lead | Device | Right ventricular apex pacing |
| Implantation procedure for a St-Jude Medical pacemaker system with left ventricular apex pacingImplantation procedure for a St-Jude Medical pacemaker system with a transvenous left ventricular (coronary sinus) and if applicable a right atrial lead | Device | Left ventricular apex pacing |
Primary outcome
Reduction in LVEF
Time frame: baseline to one year
8 secondary outcomes
Change in left ventricular end-systolic and end-diastolic volumes
Time frame: one year
Dyssynchrony evaluation during RV and LV pacing
Time frame: one year
Change in tricuspid regurgitation severity, if any
Time frame: one year
Change in mitral regurgitation severity, if any
Time frame: one year
Incidence of device-related complications
Time frame: one year
Success rate of autocapture algorithm for left-and right-ventricular pacing
Time frame: one year
Mortality and all cause hospitalization
Time frame: one year
Reduction of LVEF at 1 year compared to baseline according to the following pre-specified subgroups: a) initial LVEF, b) gender, c)etiology (coronary artery disease, nonischemic cardiomyopathy)
Time frame: one year
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haran Burri, Assoc. Prof. principal investigator
University Hospital, Geneva
Angelo Auricchio, Prof. principal investigator
Fondazione Cardiocentro Ticino (Lugano)
Christian Sticherling, Prof. study chair
University Hospital of Basel
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation procedure for a St-Jude Medical pacemaker system with right ventricular apex pacing and Implantation procedure for a St-Jude Medical pacemaker system with left ventricular apex pacing in people with Bradyarrhythmia, run by Haran Burri, MD at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Switzerland, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in LVEF (time frame: baseline to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.