Scar Location and Acute Haemodynamic Response to MultiPoint Pacing Study in Patients With Ischemic Cardiomyopathy
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|ClinicalTrials.gov Identifier: NCT04066738|
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : August 26, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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)
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066738
|Contact: Tim Betts, MD||0044 01865 email@example.com|
|Contact: Milena Leo, MDfirstname.lastname@example.org|
|John Radcliffe Hospital||Recruiting|
|Oxford, United Kingdom, OX3 9DU|