Heart FailureNCT04066738
Scar Location and Acute Haemodynamic Response to MultiPoint Pacing Study in Patients With Ischemic Cardiomyopathy
A study testing Cardiac MRI with gadolinium contrast, 3D reconstruction and location of coronary sinus venous system relative to myocardial scar and Acute haemodynamic measurements during CRT implant in people with Heart Failure and Ischemic Cardiomyopathy, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Cardiac Resynchronization Therapy (CRT) is a proven treatment for heart failure. CRT consists of a special pacemaker with two/three leads (insulated wires which take the electrical impulses from the device to the heart), one in the right ventricle, one in a vein on the outer surface of the left ventricle (in a vessel… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Ischemic Cardiomyopathy
- What is being tested?
- Cardiac MRI with gadolinium contrast, 3D reconstruction and location of coronary sinus venous system relative to myocardial scar and Acute haemodynamic measurements during CRT implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Sep 2017to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age of 18 years or over
- Previous STEMI (> 3 months before enrolment) and consequent LV scar;
- Standard indication to CRT-D (NYHA functional class III-IV despite optimal medical therapy, LV ejection fraction (LVEF) ≤35 %, QRS duration ≥120 msec, LBBB);
- Sinus rhythm;
- Will and ability to give informed consent for participation in the study.
Who cannot join
- Pregnancy, trying for a baby or breast feeding;
- Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study;
- Inability to tolerate MRI scanning (e.g. claustrophobia, unable to lie flat)
- Contraindications to MRI scanning (e.g. implantable devices, cranial aneurysm clips, metallic ocular foreign bodies, hypersensitivity to gadolinium);
- Significantly impaired renal function (eGFR < 30ml/min);
- History of allergy to cardiac MRI contrast media;
- Severe claustrophobia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SCar Location and Acute Haemodynamic Response to MultiPoint Pacing in Patients With Ischemic Cardiomyopathy (SCAR MPP Study)
Cardiac Resynchronization Therapy (CRT) is a proven treatment for heart failure.
CRT consists of a special pacemaker with two/three leads (insulated wires which take the electrical impulses from the device to the heart), one in the right ventricle, one in a vein on the outer surface of the left ventricle (in a vessel called coronary sinus or CS) and sometimes one in the right atrium (right top chamber of the heart). Tiny electrical impulses are simultaneously sent to the ventricles to make them beating together again in a more synchronised pattern. This leads to a coordinated, synchronous pumping action that, in most patients, translates into improved heart failure symptoms and improved quality and quantity of life, reducing the chance of being admitted to hospital with worsening heart failure. Unfortunately up to one third of the patients do not benefit from CRT therapy and to date there are no useful criteria to predict the response to CRT.
Read more
In an effort to improve the response rate to CRT, alternative methods have been developed. In particular, a new technology called MultiPoint Pacing (MPP) (St. Jude Medical, Sylmar, CA) has recently become available. It allows simultaneous stimulation of 2 different points in the left ventricle by using a single lead with four electrodes. This strategy should improve the pumping function of the heart by recruiting a larger mass of muscle. Although MPP is as safe and as effective as standard CRT pacing, the improvements to date in the heart pump function it gives over standard CRT pacing are variable and small.
Recent evidence suggests that MPP pacing could be particularly beneficial in some subgroups of patients, in particular patients with a previous history of heart attack resulting in scar formation in the left ventricle.
The investigators hypothesize that MPP works better when the lead is closer to the scar because this allows recruitment of areas with slow conduction, thus increasing synchronization further.
To this aim, they plan to compare, in each patient, the acute response produced by MPP on the cardiac function when the CS lead is placed close to myocardial scar and when it is placed far from scar respectively.
Read the detailed description
A prospective single-centre pilot study will be conducted to investigate this topic. Fifteen patients, with a history of previous ST Elevation Myocardial Infarction (STEMI) resulting in myocardial scar and elected to CRT implant at the OUH, will be enrolled in this study.
Compared to standard practice, additional research investigations will be a baseline visit for eligibility assessment, informed consent and pre-CRT implant cardiac MRI, a three-dimensional electroanatomical map reconstruction of the CS venous system during the standard CRT implant and the evaluation of the acute haemodynamic response (AHR, percentage increase of LV-dP/dT max) of MPP over conventional single-site LV pacing during the CRT implant.
The cardiac Magnetic Resonance Imaging (MRI) will be performed in each patient 1-2 weeks before the CRT implant during the baseline visit. It will provide information regarding presence and location of myocardial scar and anatomy of the CS venous system.
A de-novo CRT implant will be performed under fluoroscopic guidance as per standard care. All subjects will be implanted with a regulatory approved St. Jude Medical CRT device compatible with MPP feature (models n° CD3271-40(Q), CD3371-40(Q), CD3371-40C(QC) or newer) and St. Jude Medical quadripolar left ventricular lead (Quartet 1458Q or newer). The choice of the right ventricular and right atrial leads will be left to the operator. After implant of the right ventricular and right atrial leads, a CS venogram will be then performed as per standard practice (see intervention section for more details).
A three-dimensional electroanatomical map of the CS venous system will be constructed with Precision mapping system and a Biotronik Vision wire (Biotronik Se \& Co. KG, Berlin, Germany) by using the CS venogram as a guide. The map will be merged with the correspondent cardiac MRI images in order to locate the myocardial scar in respect to the CS branches. This will allow the identification of two target CS branches for the study measurements, one located in the peri-infarct region and one located in the remote myocardium.
A Certus PressureWire will be then introduced into the LV. A PhysioMon software (Radi Medical Systems, Uppsala, Sweden) will be used for electronic calculation of the LV-dP/dTmax from every heartbeat for a period of at least thirty seconds to ensure steady-state conditions. The baseline LV-dP/dTmax will be measured during ventricular spontaneous rhythm.
A St. Jude Medical quadripolar left ventricular lead will be sequentially placed in the "peri-infarct" CS branch and in the "remote myocardium" CS branch. In each site the percentage increase in LV-dP/dTmax (Acute Haemodynamic Response, AHR) produced by both conventional single-site and MPP LV pacing to will be measured. All 4 poles of the quadripolar lead will be used in turn for conventional single-site LV pacing, 3 different configurations will be used in turn for MPP. The LV-dP/dTmax will be recorded for each pacing configuration in order to identify the MPP and the single-site LV pacing configurations producing the best AHR (best percentage increase of LV-dP/dTmax).
The AHR produced by the best MPP configuration in peri-infarct region will be compared with the AHR produced by the best MPP configuration in the remote myocardium. Moreover, the percentage increase of LV-dP/dTmax produced by the best MPP configuration over the best conventional single-site LV pacing in the peri-infarct region will be compared with the same measurement obtained in the remote myocardium.
The decision about the final position of the LV lead and the activation of MPP feature after the CRT implant will be left to operator preference.
- Conditions
- Heart Failure, Ischemic Cardiomyopathy
- Being tested
- Cardiac MRI with gadolinium contrast, 3D reconstruction and location of coronary sinus venous system relative to myocardial scar, Acute haemodynamic measurements during CRT implant
- Keywords
- MultiPoint Pacing, Acute Haemodynamic Response
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRI with gadolinium contrastDiagnostic test
Imaging of left ventricular scar and coronary sinus venous system
3D reconstruction and location of coronary sinus venous system relative to myocardial scarDiagnostic test
Three dimensional mapping of coronary sinus venous system with Abbott Precision mapping system and Biotronik Vision wire Merge with MRI images of CS and myocardial scar
Acute haemodynamic measurements during CRT implantDiagnostic test
Advancement of pressure wire to LV cavity via femoral/radial arterial access. Real time measurement of LV-dP/dTmax during conventional CRT and MPP after consecutive placement of LV lead in two different CS branches (peri-infarct region and remote myocardium)
| Study group | Role | What they receive |
|---|---|---|
| Patients with myocardial scar | Other | Patient with previous STEMI resulting in myocardial scar, elected to CRT implant Receives: Diagnostic Test: Cardiac MRI with gadolinium contrast; Diagnostic Test: 3D reconstruction and location of coronary sinus venous system relative to myocardial scar; Diagnostic Test: Acute haemodynamic measurements during CRT implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Acute Haemodynamic Response Produced by MPP in Peri-infarct Region and in the Remote Myocardium
Comparison between
- percentage change of maximal left ventricular pressure over time (LV-dP/dTmax) produced by multipoint pacing (MPP) over spontaneous ventricular activation in the peri-infarct region and
- percentage change of maximal left ventricular pressure over time (LV-dP/dTmax) produced by multipoint pacing (MPP) over spontaneous ventricular activation in the remote myocardium
Measured: Day 1
Comparison Between MPP and Standard CRT Pacing in Terms of Acute Haemodynamic Response
Percentage change of LV dP/dT max produced by MPP over conventional single-site LV pacing in the peri-infarct region compared to the remote myocardium
Comparison between
- percentage change of maximal left ventricular pressure over time (LV-dP/dTmax) produced by multipoint pacing (MPP) over conventional CRT pacing in the peri-infarct region and
- percentage change of maximal left ventricular pressure over time (LV-dP/dTmax) produced by multipoint pacing (MPP) over conventional CRT in the remote myocardium
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start27 Sep 2017
- Primary completion23 Oct 2017
- Study completion30 Mar 2020
Why it stopped: Unable to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Principal investigator, Tim Betts MD MBChB FRCP, Oxford University Hospitals NHS Trust
- Investigators
- Tim Betts, MD, Principal investigator, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066738
- Sponsor's protocol ID
- 12193
- Status last verified
- Mar 2022
- First submitted
- 17 Apr 2019
- Last updated
- 18 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCar Location and Acute Haemodynamic Response to MultiPoint Pacing in Patients With Ischemic Cardiomyopathy (SCAR MPP Study)
- ClinicalTrials.gov ID
- NCT04066738
- Acronym / sponsor ID
- 12193
- Conditions
- Heart Failure, Ischemic Cardiomyopathy
- Keywords
- MultiPoint Pacing, Acute Haemodynamic Response
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 27 Sep 2017 (actual)
- Primary completion
- 23 Oct 2017 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 26 Aug 2019 (actual)
- Results
- Posted 18 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiac Resynchronization Therapy (CRT) is a proven treatment for heart failure.
CRT consists of a special pacemaker with two/three leads (insulated wires which take the electrical impulses from the device to the heart), one in the right ventricle, one in a vein on the outer surface of the left ventricle (in a vessel called coronary sinus or CS) and sometimes one in the right atrium (right top chamber of the heart). Tiny electrical impulses are simultaneously sent to the ventricles to make them beating together again in a more synchronised pattern. This leads to a coordinated, synchronous pumping action that, in most patients, translates into improved heart failure symptoms and improved quality and quantity of life, reducing the chance of being admitted to hospital with worsening heart failure. Unfortunately up to one third of the patients do not benefit from CRT therapy and to date there are no useful criteria to predict the response to CRT.
In an effort to improve the response rate to CRT, alternative methods have been developed. In particular, a new technology called MultiPoint Pacing (MPP) (St. Jude Medical, Sylmar, CA) has recently become available. It allows simultaneous stimulation of 2 different points in the left ventricle by using a single lead with four electrodes. This strategy should improve the pumping function of the heart by recruiting a larger mass of muscle. Although MPP is as safe and as effective as standard CRT pacing, the improvements to date in the heart pump function it gives over standard CRT pacing are variable and small.
Recent evidence suggests that MPP pacing could be particularly beneficial in some subgroups of patients, in particular patients with a previous history of heart attack resulting in scar formation in the left ventricle.
The investigators hypothesize that MPP works better when the lead is closer to the scar because this allows recruitment of areas with slow conduction, thus increasing synchronization further.
To this aim, they plan to compare, in each patient, the acute response produced by MPP on the cardiac function when the CS lead is placed close to myocardial scar and when it is placed far from scar respectively.
Detailed description
A prospective single-centre pilot study will be conducted to investigate this topic. Fifteen patients, with a history of previous ST Elevation Myocardial Infarction (STEMI) resulting in myocardial scar and elected to CRT implant at the OUH, will be enrolled in this study.
Compared to standard practice, additional research investigations will be a baseline visit for eligibility assessment, informed consent and pre-CRT implant cardiac MRI, a three-dimensional electroanatomical map reconstruction of the CS venous system during the standard CRT implant and the evaluation of the acute haemodynamic response (AHR, percentage increase of LV-dP/dT max) of MPP over conventional single-site LV pacing during the CRT implant.
The cardiac Magnetic Resonance Imaging (MRI) will be performed in each patient 1-2 weeks before the CRT implant during the baseline visit. It will provide information regarding presence and location of myocardial scar and anatomy of the CS venous system.
A de-novo CRT implant will be performed under fluoroscopic guidance as per standard care. All subjects will be implanted with a regulatory approved St. Jude Medical CRT device compatible with MPP feature (models n° CD3271-40(Q), CD3371-40(Q), CD3371-40C(QC) or newer) and St. Jude Medical quadripolar left ventricular lead (Quartet 1458Q or newer). The choice of the right ventricular and right atrial leads will be left to the operator. After implant of the right ventricular and right atrial leads, a CS venogram will be then performed as per standard practice (see intervention section for more details).
A three-dimensional electroanatomical map of the CS venous system will be constructed with Precision mapping system and a Biotronik Vision wire (Biotronik Se \& Co. KG, Berlin, Germany) by using the CS venogram as a guide. The map will be merged with the correspondent cardiac MRI images in order to locate the myocardial scar in respect to the CS branches. This will allow the identification of two target CS branches for the study measurements, one located in the peri-infarct region and one located in the remote myocardium.
A Certus PressureWire will be then introduced into the LV. A PhysioMon software (Radi Medical Systems, Uppsala, Sweden) will be used for electronic calculation of the LV-dP/dTmax from every heartbeat for a period of at least thirty seconds to ensure steady-state conditions. The baseline LV-dP/dTmax will be measured during ventricular spontaneous rhythm.
A St. Jude Medical quadripolar left ventricular lead will be sequentially placed in the "peri-infarct" CS branch and in the "remote myocardium" CS branch. In each site the percentage increase in LV-dP/dTmax (Acute Haemodynamic Response, AHR) produced by both conventional single-site and MPP LV pacing to will be measured. All 4 poles of the quadripolar lead will be used in turn for conventional single-site LV pacing, 3 different configurations will be used in turn for MPP. The LV-dP/dTmax will be recorded for each pacing configuration in order to identify the MPP and the single-site LV pacing configurations producing the best AHR (best percentage increase of LV-dP/dTmax).
The AHR produced by the best MPP configuration in peri-infarct region will be compared with the AHR produced by the best MPP configuration in the remote myocardium. Moreover, the percentage increase of LV-dP/dTmax produced by the best MPP configuration over the best conventional single-site LV pacing in the peri-infarct region will be compared with the same measurement obtained in the remote myocardium.
The decision about the final position of the LV lead and the activation of MPP feature after the CRT implant will be left to operator preference.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with myocardial scar | Other | Diagnostic Test: Cardiac MRI with gadolinium contrast, Diagnostic Test: 3D reconstruction and location of coronary sinus venous system relative to myocardial scar, Diagnostic Test: Acute haemodynamic measurements during CRT implantPatient with previous STEMI resulting in myocardial scar, elected to CRT implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age of 18 years or over
- Previous STEMI (> 3 months before enrolment) and consequent LV scar;
- Standard indication to CRT-D (NYHA functional class III-IV despite optimal medical therapy, LV ejection fraction (LVEF) ≤35 %, QRS duration ≥120 msec, LBBB);
- Sinus rhythm;
- Will and ability to give informed consent for participation in the study.
Key exclusion criteria (7 listed)
- Pregnancy, trying for a baby or breast feeding;
- Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study;
- Inability to tolerate MRI scanning (e.g. claustrophobia, unable to lie flat)
- Contraindications to MRI scanning (e.g. implantable devices, cranial aneurysm clips, metallic ocular foreign bodies, hypersensitivity to gadolinium);
- Significantly impaired renal function (eGFR < 30ml/min);
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 |
|---|---|---|
| Cardiac MRI with gadolinium contrastImaging of left ventricular scar and coronary sinus venous system | Diagnostic test | Patients with myocardial scar |
| 3D reconstruction and location of coronary sinus venous system relative to myocardial scarThree dimensional mapping of coronary sinus venous system with Abbott Precision mapping system and Biotronik Vision wire Merge with MRI images of CS and myocardial scar | Diagnostic test | Patients with myocardial scar |
| Acute haemodynamic measurements during CRT implantAdvancement of pressure wire to LV cavity via femoral/radial arterial access. Real time measurement of LV-dP/dTmax during conventional CRT and MPP after consecutive placement of LV lead in two different CS branches (peri-infarct region and remote myocardium) | Diagnostic test | Patients with myocardial scar |
Primary outcome
Comparison of Acute Haemodynamic Response Produced by MPP in Peri-infarct Region and in the Remote Myocardium
Time frame: Day 1
Comparison between 1. percentage change of maximal left ventricular pressure over time (LV-dP/dTmax) produced by multipoint pacing (MPP) over spontaneous ventricular activation in the peri-infarct region and 2. percentage change of maximal left ventricular pressure over time (LV-dP/dTmax) produced by multipoint pacing (MPP) over spontaneous ventricular activation in the remote myocardium
Comparison Between MPP and Standard CRT Pacing in Terms of Acute Haemodynamic Response
Time frame: Day 1
Percentage change of LV dP/dT max produced by MPP over conventional single-site LV pacing in the peri-infarct region compared to the remote myocardium Comparison between 1. percentage change of maximal left ventricular pressure over time (LV-dP/dTmax) produced by multipoint pacing (MPP) over conventional CRT pacing in the peri-infarct region and 2. percentage change of maximal left ventricular pressure over time (LV-dP/dTmax) produced by multipoint pacing (MPP) over conventional CRT in the remote myocardium
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Tim Betts, MD principal investigator
Oxford University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac MRI with gadolinium contrast, 3D reconstruction and location of coronary sinus venous system relative to myocardial scar and Acute haemodynamic measurements during CRT implant in people with Heart Failure and Ischemic Cardiomyopathy, run by Oxford University Hospitals NHS 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 5 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 18 May 2022. 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?
Yes. Results are posted in the registry (first posted 18 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Comparison of Acute Haemodynamic Response Produced by MPP in Peri-infarct Region and in the Remote Myocardium (time frame: Day 1). The study lists 2 primary outcomes in all. 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 18 May 2022.