Sick Sinus SyndromeNCT02198781
Right Ventricle (RV) Markers of Future Pacing Induced Ventricular Dysfunction - Pilot
An observational study of Sick Sinus Syndrome, run by Mid and South Essex NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This is a pilot study into the effects on heart function when pacing the right ventricle (RV). This study aims to enrol a population who are clinically indicated to receive a pacemaker. When normal conduction within the heart fails, the treatment may be to implant a permanent pacemaker. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sick Sinus Syndrome
- How many people
- 3 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2014to Aug 2015
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are due to undergo permanent pacemaker (PPM) implantation will be recruited to undergo RV Pressure/Volume loop assessment and RV strain ECHO at the same time as PPM implant for pilot data regarding the acute effects of RV pacing on RV haemodynamics
Who may be able to join
- Patient undergoing permanent pacemaker (PPM) implantation
- Age 18-80 years old
- High grade atrial-ventricular (AV) block
- Preserved left ventricle (LV) systolic function on pre-procedure Echocardiogram (EF>45%)
Who cannot join
- Atrial Fibrillation
- Recent myocardial infarct (MI)
- Pregnancy
- Enrolment in any other study
- Inability or refusal to comply with the follow-up schedule
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Essex Cardiothoracic Centre
Basildon, Essex, SS16 5NL
About this study
Official title: Does a Measure Exist in the Right Ventricle Which Can Act as a Surrogate Marker for Future Ventriclar Sysfunction When Pacing - a Pilot Study
This is a pilot study into the effects on heart function when pacing the right ventricle (RV). This study aims to enrol a population who are clinically indicated to receive a pacemaker.
When normal conduction within the heart fails, the treatment may be to implant a permanent pacemaker. Pacing involves passing a lead via a vein to the heart and using an electrical impulse to stimulate a beat.
Read more
Increasingly the available evidence suggests that long term RV pacing is associated with complications - left ventricule (LV) dysfunction, heart failure, atrial fibrillation (AF) and death in some patients. What we do not see are a large proportion of all patients who receive pacemakers suffering pacing related adverse effects.
If there could be a way of identifying those patients in the group who go on to develop pacing induced cardiomyopathy at the time of initial pacing implant, this would be a very valuable clinical measure. These patients could be identified from the outset and paced with a biventricular device to avoid the pacing induced cardiomyopathy. Whilst much energy has been directed towards the LV as a focus of the clinical markers of disease, little has been published looking at RV haemodynamics.
We plan to study a cohort of patients who are clinically indicated to receive a pacemaker and study their RV in detail at the time of implantation. We will use conductance catheters and echocardiography to determine measures of pumping function. We will then follow them up for a period of six month using echocardiography and blood markers of heart dysfunction. In those patients who have a reduction in heart function we will then look for common patterns within their initial measurements.
Read the detailed description
This study is designed to explore whether a marker exists within the right ventricle (RV) that may suggest future pacing induced dysfunction of the heart. Pacing the heart is a necessary procedure when normal conduction has failed. It has been shown in some patients to result in deleterious effects on the pumping function of the left ventricle acutely and chronically. Little has been looked into within right ventricular function and how this interacts with the left side. The fact that this dysfunction is not seen in all patients who receive pacemakers is important and we aim to use these pure haemodynamic measures to investigate this issue and try to identify those patients who may go on to have pacing induced dysfunction. This is an important scientific question to answer as we know that these patients can be spared the ventricular dysfunction by the intervention of biventricular pacing at the time of initial implantation. What we do not know is how to choose this group at the outset.
The study has been designed as a pilot investigation using patients who are to undergo permanent pacemaker therapy. Our study will entail one additional catheter being passed to the heart and also one to the inferior vena cava. This measurement of heart function will be performed directly after the implantation of the pacemaker and will add only a small amount of time to the case.
We will then follow these patients up and take echocardiographic data as well as blood markers of impaired ventricular function at 6 months.
The design of this study is that of a cohort study with the common exposure being that of pacemaker therapy. We seek to take detailed haemodynamic and echocardiographic measurements at the time of implantation. This will yield powerful data when cross referenced to cases of adverse ventricular function seen due to pacing at follow up. We aim to perform this pilot study as a feasibility process in order to ascertain the frequency of measurable adverse effects in this population and gain early insights into the markers we can look for. We do not know this data at present. This will allow for a future definitive study to be designed with appropriate participant numbers and follow up periods. The follow up period of 6 months has been set in order to fit within the time constraints of an ongoing MD undertaking.
Patients who are being booked for a pacemaker implantation as per the normal course of their treatment will be eligible to enter the study as long as they have a high anticipated pacing component. This means that these patients would be expected to have their heart stimulated via the pacemaker most of the time under normal circumstances of their care.
Patients are not eligible if they have atrial fibrillation (AF). This decision was made as patients with AF have a very different activation pattern of the heart due to the irregularity of heart rhythm and thus this would be a confounding factor to the study.
We will approach patients who meet eligibility criteria who are on the waiting list for pacemaker implantation. We will explain that this is an adjunctive procedure to the Pacemaker implant and purely for research purposes with no therapeutic benefit at the time of the procedure. We will explain the follow up needs of the study and that there potentially is a benefit to them to be followed up closely as per research protocol although this is not normal clinical workflow. Any questions will be answered at that time and consent will at a later time in preassessment clinic.
Written consent will be obtained prior to the study. The patients have the right to withdraw from the trial at any point. Consent will be verbally reconfirmed before the procedure. This process will be recorded within the medical notes at each stage.
The additional risk to the patient is insertion of the venous sheaths into the femoral vein. This is performed routinely with every electrophysiology study which is a commonly performed cardiac investigation. Very rarely the veins require to be repaired by a surgeon (1 in 500). Bleeding or bruising may occur around the sheath. Insertion of the conductance catheter into the heart may rarely (<1 in 1000) cause structural damage.
- Conditions
- Sick Sinus Syndrome
- Keywords
- atrial fibrilation, atrial-ventricula, right ventricle, left ventricle, surrogate marker, ventricular dysfunction, pacing
- Medical subject headings
- Sick Sinus Syndrome, Ventricular Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Basic science study |
What is being measured
The primary outcome is the main question the study is designed to answer.
surrogate marker
To identify any surrogate markers for this patient cohort
Measured: 30 minutes
Secondary outcomes (1)
dyssynchronous index
To identify if any dyssynchronour index can be obtained in the right ventricle in this cohort
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sick Sinus SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mid and South Essex NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Anglia Ruskin University
- Responsible party
- Sponsor
- Investigators
- Stuart Tan, MB BC, MRCP, Principal investigator, Mid and South Essex NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198781
- Sponsor's protocol ID
- B729
- Status last verified
- Dec 2020
- First submitted
- 22 Jul 2014
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Measure Exist in the Right Ventricle Which Can Act as a Surrogate Marker for Future Ventriclar Sysfunction When Pacing - a Pilot Study
- ClinicalTrials.gov ID
- NCT02198781
- Acronym / sponsor ID
- B729
- Conditions
- Sick Sinus Syndrome
- Keywords
- atrial fibrilation, atrial-ventricula, right ventricle, left ventricle, surrogate marker, ventricular dysfunction, pacing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Mid and South Essex NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Anglia Ruskin University
- Study start
- Jul 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 24 Jul 2014 (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.
This is a pilot study into the effects on heart function when pacing the right ventricle (RV). This study aims to enrol a population who are clinically indicated to receive a pacemaker.
When normal conduction within the heart fails, the treatment may be to implant a permanent pacemaker. Pacing involves passing a lead via a vein to the heart and using an electrical impulse to stimulate a beat.
Increasingly the available evidence suggests that long term RV pacing is associated with complications - left ventricule (LV) dysfunction, heart failure, atrial fibrillation (AF) and death in some patients. What we do not see are a large proportion of all patients who receive pacemakers suffering pacing related adverse effects.
If there could be a way of identifying those patients in the group who go on to develop pacing induced cardiomyopathy at the time of initial pacing implant, this would be a very valuable clinical measure. These patients could be identified from the outset and paced with a biventricular device to avoid the pacing induced cardiomyopathy. Whilst much energy has been directed towards the LV as a focus of the clinical markers of disease, little has been published looking at RV haemodynamics.
We plan to study a cohort of patients who are clinically indicated to receive a pacemaker and study their RV in detail at the time of implantation. We will use conductance catheters and echocardiography to determine measures of pumping function. We will then follow them up for a period of six month using echocardiography and blood markers of heart dysfunction. In those patients who have a reduction in heart function we will then look for common patterns within their initial measurements.
Detailed description
This study is designed to explore whether a marker exists within the right ventricle (RV) that may suggest future pacing induced dysfunction of the heart. Pacing the heart is a necessary procedure when normal conduction has failed. It has been shown in some patients to result in deleterious effects on the pumping function of the left ventricle acutely and chronically. Little has been looked into within right ventricular function and how this interacts with the left side. The fact that this dysfunction is not seen in all patients who receive pacemakers is important and we aim to use these pure haemodynamic measures to investigate this issue and try to identify those patients who may go on to have pacing induced dysfunction. This is an important scientific question to answer as we know that these patients can be spared the ventricular dysfunction by the intervention of biventricular pacing at the time of initial implantation. What we do not know is how to choose this group at the outset.
The study has been designed as a pilot investigation using patients who are to undergo permanent pacemaker therapy. Our study will entail one additional catheter being passed to the heart and also one to the inferior vena cava. This measurement of heart function will be performed directly after the implantation of the pacemaker and will add only a small amount of time to the case.
We will then follow these patients up and take echocardiographic data as well as blood markers of impaired ventricular function at 6 months.
The design of this study is that of a cohort study with the common exposure being that of pacemaker therapy. We seek to take detailed haemodynamic and echocardiographic measurements at the time of implantation. This will yield powerful data when cross referenced to cases of adverse ventricular function seen due to pacing at follow up. We aim to perform this pilot study as a feasibility process in order to ascertain the frequency of measurable adverse effects in this population and gain early insights into the markers we can look for. We do not know this data at present. This will allow for a future definitive study to be designed with appropriate participant numbers and follow up periods. The follow up period of 6 months has been set in order to fit within the time constraints of an ongoing MD undertaking.
Patients who are being booked for a pacemaker implantation as per the normal course of their treatment will be eligible to enter the study as long as they have a high anticipated pacing component. This means that these patients would be expected to have their heart stimulated via the pacemaker most of the time under normal circumstances of their care.
Patients are not eligible if they have atrial fibrillation (AF). This decision was made as patients with AF have a very different activation pattern of the heart due to the irregularity of heart rhythm and thus this would be a confounding factor to the study.
We will approach patients who meet eligibility criteria who are on the waiting list for pacemaker implantation. We will explain that this is an adjunctive procedure to the Pacemaker implant and purely for research purposes with no therapeutic benefit at the time of the procedure. We will explain the follow up needs of the study and that there potentially is a benefit to them to be followed up closely as per research protocol although this is not normal clinical workflow. Any questions will be answered at that time and consent will at a later time in preassessment clinic.
Written consent will be obtained prior to the study. The patients have the right to withdraw from the trial at any point. Consent will be verbally reconfirmed before the procedure. This process will be recorded within the medical notes at each stage.
The additional risk to the patient is insertion of the venous sheaths into the femoral vein. This is performed routinely with every electrophysiology study which is a commonly performed cardiac investigation. Very rarely the veins require to be repaired by a surgeon (1 in 500). Bleeding or bruising may occur around the sheath. Insertion of the conductance catheter into the heart may rarely (<1 in 1000) cause structural damage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | –Basic science study |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are due to undergo permanent pacemaker (PPM) implantation will be recruited to undergo RV Pressure/Volume loop assessment and RV strain ECHO at the same time as PPM implant for pilot data regarding the acute effects of RV pacing on RV haemodynamics
Key inclusion criteria (4 listed)
- Patient undergoing permanent pacemaker (PPM) implantation
- Age 18-80 years old
- High grade atrial-ventricular (AV) block
- Preserved left ventricle (LV) systolic function on pre-procedure Echocardiogram (EF>45%)
Key exclusion criteria (5 listed)
- Atrial Fibrillation
- Recent myocardial infarct (MI)
- Pregnancy
- Enrolment in any other study
- Inability or refusal to comply with the follow-up schedule
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
surrogate marker
Time frame: 30 minutes
To identify any surrogate markers for this patient cohort
1 secondary outcome
dyssynchronous index
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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.
Stuart Tan, MB BC, MRCP principal investigator
Mid and South Essex NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sick Sinus Syndrome, run by Mid and South Essex NHS Foundation Trust at 1 site in United Kingdom.
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 5 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: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
surrogate marker (time frame: 30 minutes). 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 22 Dec 2020.