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

NCT04066738 | Terminated Results

• 1 other identifier: 12193
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Ischemic Cardiomyopathy

Keywords

MultiPoint Pacing; Acute Haemodynamic Response

Outcome Measures

Primary Outcomes (2)

• Comparison of Acute Haemodynamic Response Produced by MPP in Peri-infarct Region and in the Remote Myocardium

  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

  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 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

  Day 1

Study Arms (1)

Patients with myocardial scar

OTHER

Patient with previous STEMI resulting in myocardial scar, elected to CRT implant

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

Interventions

Cardiac MRI with gadolinium contrast DIAGNOSTIC_TEST

Imaging of left ventricular scar and coronary sinus venous system

Patients with myocardial scar

3D reconstruction and location of coronary sinus venous system relative to myocardial scar DIAGNOSTIC_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

Patients with myocardial scar

Acute haemodynamic measurements during CRT implant DIAGNOSTIC_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)

Patients with myocardial scar

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Prof. Tim Betts
• Organization: Oxford University Hospitals NHS Foundation Trust

ep.doctors@ouh.nhs.uk

01865 220256

Study Officials

• Tim Betts, MD

  Oxford University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, Consultant Cardiologist

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: August 26, 2019
• Study Start: September 27, 2017
• Primary Completion: October 23, 2017
• Study Completion: March 30, 2020
• Last Updated: May 18, 2022
• Results First Posted: May 18, 2022

Record last verified: 2022-03

Locations

GB (1)