Trial Outcomes & Findings for Scar Location and Acute Haemodynamic Response to MultiPoint Pacing Study in Patients With Ischemic Cardiomyopathy (NCT NCT04066738)

Last Updated: 2022-05-18

Results Overview

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

Recruitment status

TERMINATED

Study phase

Target enrollment

2 participants

Primary outcome timeframe

Day 1

Results posted on

2022-05-18

Participant Flow

Participant milestones

Participant milestones
Measure	Patients With Myocardial Scar Patient with previous STEMI resulting in myocardial scar, elected to CRT implant Cardiac MRI with gadolinium contrast: Imaging of left ventricular scar and coronary sinus venous system 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 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)
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Myocardial Scar n=2 Participants Patient with previous STEMI resulting in myocardial scar, elected to CRT implant Cardiac MRI with gadolinium contrast: Imaging of left ventricular scar and coronary sinus venous system 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 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)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	65 years STANDARD_DEVIATION 2.83 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United Kingdom	2 Participants n=5 Participants
dP/dt produced by MPP in the peri-infarct region	1030.5 mmHg/sec STANDARD_DEVIATION 92.63 • n=5 Participants
dP/dt produced by MPP in the remote myocardium	920.41 mmHg/sec STANDARD_DEVIATION 44.42 • n=5 Participants
dP/dt produced by RV pacing	893.03 mmHg/sec STANDARD_DEVIATION 83.82 • n=5 Participants
dP/dt produced by CRT pacing in the peri-infarct region	945 mmHg/sec STANDARD_DEVIATION 82.02 • n=5 Participants
dP/dt produced by CRT pacing in the remote myocardium	1050.5 mmHg/sec STANDARD_DEVIATION 7.78 • n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Outcome measures

Outcome measures
Measure	Patients With Myocardial Scar n=2 Participants Patient with previous STEMI resulting in myocardial scar, elected to CRT implant Cardiac MRI with gadolinium contrast: Imaging of left ventricular scar and coronary sinus venous system 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 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 the Remote Myocardium	12.97 percentage change of dP/dT (mmHg/sec) Standard Deviation 0.95

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Patients With Myocardial Scar n=2 Participants Patient with previous STEMI resulting in myocardial scar, elected to CRT implant Cardiac MRI with gadolinium contrast: Imaging of left ventricular scar and coronary sinus venous system 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 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 Between MPP and Standard CRT Pacing in Terms of Acute Haemodynamic Response	13.49 percentage change of dP/dT (mmHg/sec) Standard Deviation 4.81

Adverse Events

Patients With Myocardial Scar

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Tim Betts

Oxford University Hospitals NHS Foundation Trust

Phone: 01865 220256

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place