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Scar Location and Acute Haemodynamic Response to MultiPoint Pacing Study in Patients With Ischemic Cardiomyopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04066738
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Dr Tim Betts MD MBChB FRCP, Oxford University Hospitals NHS Trust

Brief 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 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.


Condition or disease Intervention/treatment Phase
Heart Failure Ischemic Cardiomyopathy 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SCar Location and Acute Haemodynamic Response to MultiPoint Pacing in Patients With Ischemic Cardiomyopathy (SCAR MPP Study)
Actual Study Start Date : September 27, 2017
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy Scars

Arm Intervention/treatment
Patients with myocardial scar
Patient with previous STEMI resulting in myocardial scar, elected to CRT implant
Diagnostic Test: Cardiac MRI with gadolinium contrast
Imaging of left ventricular scar and coronary sinus venous system

Diagnostic Test: 3D reconstruction and location of coronary sinus venous system relative to myocardial scar
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

Diagnostic Test: Acute haemodynamic measurements during CRT implant
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)




Primary Outcome Measures :
  1. Comparison of acute haemodynamic response produced by MPP in peri-infarct region and in remote myocardium respectively [ Time Frame: Day 1 ]
    Percentage change of LV-dP/dTmax produced by MPP over spontaneous ventricular activation in the peri-infarct region and in the remote myocardium

  2. Comparison between MPP and standard 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, both in the peri-infarct region and in the remote myocardium



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066738


Contacts
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Contact: Tim Betts, MD 0044 01865 220256 tim.betts@ouh.nhs.uk
Contact: Milena Leo, MD milena.leo@ouh.nhs.uk

Locations
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United Kingdom
John Radcliffe Hospital Recruiting
Oxford, United Kingdom, OX3 9DU
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
National Institute for Health Research, United Kingdom
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Responsible Party: Dr Tim Betts MD MBChB FRCP, Principle Investigator, Consultant Cardiologist, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT04066738    
Other Study ID Numbers: 12193
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Tim Betts MD MBChB FRCP, Oxford University Hospitals NHS Trust:
MultiPoint Pacing
Acute Haemodynamic Response
Additional relevant MeSH terms:
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Cardiomyopathies
Ischemia
Heart Diseases
Cardiovascular Diseases
Pathologic Processes