Conduction System Pacing Optimized Therapy

Not Applicable

Completed

Conditions: Heart Failure

Interventions: Device: Left ventricular coronary sinus configuration
Device: Conduction system pacing-only configuration
Device: Conduction System Pacing Optimized Therapy (CSPOT) configuration

Registration Number: NCT04905290

Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief Summary: The purpose of the CSPOT study is to determine the best mode of cardiac resynchronization therapy (CRT) pacing for different populations of CRT patients, comparing traditional biventricular or left ventricular pacing (BiV), conduction system pacing (CSP)-only, and conduction system pacing optimized therapy (CSPOT) also known as a combination of conduction system pacing (CSP) and left ventricular (LV) pacing. Additionally, safety of the system will be assessed.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

Inclusion Criteria

Patient is willing and able to provide written informed consent
Subject is at least 18 years of age
Patient is willing and able to comply with the protocol, including follow-up visits
The patient's medical records must be accessible by the enrolling site over the follow-up period
Standard CRT-D or CRT-P indications, with a preference for IVCD and non-LBBB patients, where LBBB is defined according to Strauss criteria.
De-novo CRT implant, including upgrade from pacemaker or ICD

Exclusion Criteria

Subject has persistent or permanent AF (Atrial Fibrillation)/AFL (Atrial Flutter)
Subject has 2nd or 3rd degree AV (Atrioventricular) Block
Subject has RBBB with no additional conduction block
Subject has intrinsic (non-paced) QRS width less than or equal to 120 ms
Subject experienced MI within 40 days prior to enrollment
Subject underwent valve surgery, within 90 days prior to enrollment
Subject is post heart transplantation or is actively listed on the transplantation list
Subject is implanted with a LV assist device
Subject has severe renal disease
Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure
Subject has severe aortic stenosis (with a valve area of <1.0 cm or significant valve disease expected to be operated within study period)
Subject has severe aortic calcification or severe peripheral arterial disease
Subject has complex and uncorrected congenital heart disease
Subject has mechanical heart valve
Pregnant or breastfeeding woman (pregnancy test required for woman of child-bearing potential and who are not on a reliable form of birth regulation method or abstinence)
Subject is enrolled in another study that could confound the results of this study without documented pre-approval from Medtronic study manager

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Conduction System Pacing Optimized Therapy (CSPOT) configuration	On the date of implant, subjects will undergo Conduction System Pacing Optimized Therapy (CSPOT) lead placement, then Conduction System Pacing Optimized Therapy (CSPOT) acute pacing protocol, and then device implant. During the acute pacing protocol, all subjects will undergo three types of pacing configurations (defined in the intervention descriptions), and will serve as their own control. The subject will then be implanted with the cardiac resynchronization therapy defibrillator (CRT-D) or cardiac resynchronization therapy pacemaker (CRT-P) device will be implanted. Each subject's device will be programmed to conduction system pacing optimized therapy (CSPOT) configuration. Subjects will be followed for 6 months.
Single Arm	Left ventricular coronary sinus configuration	On the date of implant, subjects will undergo Conduction System Pacing Optimized Therapy (CSPOT) lead placement, then Conduction System Pacing Optimized Therapy (CSPOT) acute pacing protocol, and then device implant. During the acute pacing protocol, all subjects will undergo three types of pacing configurations (defined in the intervention descriptions), and will serve as their own control. The subject will then be implanted with the cardiac resynchronization therapy defibrillator (CRT-D) or cardiac resynchronization therapy pacemaker (CRT-P) device will be implanted. Each subject's device will be programmed to conduction system pacing optimized therapy (CSPOT) configuration. Subjects will be followed for 6 months.
Single Arm	Conduction system pacing-only configuration	On the date of implant, subjects will undergo Conduction System Pacing Optimized Therapy (CSPOT) lead placement, then Conduction System Pacing Optimized Therapy (CSPOT) acute pacing protocol, and then device implant. During the acute pacing protocol, all subjects will undergo three types of pacing configurations (defined in the intervention descriptions), and will serve as their own control. The subject will then be implanted with the cardiac resynchronization therapy defibrillator (CRT-D) or cardiac resynchronization therapy pacemaker (CRT-P) device will be implanted. Each subject's device will be programmed to conduction system pacing optimized therapy (CSPOT) configuration. Subjects will be followed for 6 months.

Primary Outcome Measures

Name	Time	Method
Electrical Synchronization Response	At implant during acute protocol	Standard Deviation of Activation Times (SDAT) is a measurement of dyssynchrony, taken by the ECG belt. As described in the SDAT Acute Protocol (below) and intervention sections, percent change in SDAT from AV-only pacing was calculated for each patient-pacing configuration combination over the 5 AV delays. Within each patient the difference between CSPOT SDAT and CSP SDAT and the difference between CSPOT SDAT and BiV SDAT were taken. The mean of those differences across patients was calculated along with a 95% confidence interval.
Hemodynamic Response	At implant during acute protocol	Left Ventricular (LV) dP/dt max, a measurement of the initial velocity of myocardial contraction. As described in the LV dP/dt max (below) and intervention sections, percent change in LV dP/dt max from AV-only pacing was calculated for each patient-pacing configuration combination over the 5 AV delays. Within each patient the difference between CSPOT SDAT and CSP SDAT and the difference between CSPOT SDAT and BiV SDAT were taken. The mean of those differences across patients was calculated along with a 95% confidence interval.

Secondary Outcome Measures

Name	Time	Method
Left Ventricular Ejection Fraction (LVEF)	Baseline and 6 months	Left ventricular ejection fraction will be measured, based on echocardiography, at the baseline visit and again at the 6-month follow-up visit. Change will be calculated as the value observed at baseline subtracted from the value observed at 6 months.
Left Ventricular End Systolic Volume (LVESV)	Baseline and 6 months	Left ventricular end systolic volume will be measured, based on echocardiography, at the baseline visit and again at the 6-month follow-up visit. The change will be calculated as difference between the 6-month and baseline values, divided by the baseline value.
Clinical Composite Score (CCS)	6 months	The Clinical Composite Score (CCS) is a validated 3-level categorical variable that can take the values - Improved, Unchanged, or Worsened - at each follow-up visit. It is based on mortality, HF events, termination of device function, NYHA score, and patient global assessment. Briefly, the scoring system is as follows: * A patient is considered "worsened" if they die, demonstrate a worsened NYHA class, report at least moderately worsened heart-failure symptoms, or are hospitalized or permanently discontinue therapy because of or associated with worsening heart-failure * A patient is considered "improved" if they have not "worsened" and either demonstrate improvement in NYHA class or report at least moderately improved heart-failure symptoms * A patient is considered "stabilized" if they have not "worsened" or "improved" * A patient is considered "unavailable" if they did not complete 6-month visit and was not "worsened"
Absolute Percent Change in SDAT by QRS Subgroup	At Implant during acute protocol	Percent change in SDAT (as described in Primary Outcome 1: Arm/Group Description) by baseline QRS subgroup for each pacing configuration CSP, BiV, CSPOT during acute protocol at implant. The QRS subgroups were subjects with QRS width greater than 171ms and QRS width less than or equal to 171ms as measured by 12-lead ECG
Absolute Percent Change in SDAT Split by Subjects With Pure LBBB and With Other Conduction Disorders	At Implant during acute protocol	Percent change in SDAT (as described in Primary Outcome 1: Arm/Group Description) split by subjects with pure Left Bundle Branch Block (LBBB) and with other Conduction Disorders for each pacing configuration CSP, BiV and CSPOT during acute protocol.
Absolute Percent Change in SDAT Split by Subjects With Ischemic Cardiomyopathy and Those With Non-Ischemic Cardiomyopathy	At Implant during acute protocol	Absolute Percent change in SDAT (as described in Primary Outcome 1: Arm/Group Description) split by subjects with Ischemic Cardiomyopathy and those with Non-Ischemic Cardiomyopathy for each pacing configuration CSP, BiV and CSPOT during acute protocol.
Percent Change in LV dP/dt Max Split by Subjects With Ischemic Cardiomyopathy and Those With Non-Ischemic Cardiomyopathy	At Implant during acute protocol	Percent change in LV dP/dt max (as described in Primary Outcome 2: Arm/Group Description)split by subjects with Ischemic Cardiomyopathy and those with Non-Ischemic Cardiomyopathy for each pacing configuration CSP, BiV and CSPOT during acute protocol.
Percent Change in LV dP/dt Max Split by Subjects With Pure Left Bundle Branch Block (LBBB) and With Other Conduction Disorders (NIVCD)	At Implant during acute protocol	Percent change in LV dP/dt max (as described in Primary Outcome 2: Arm/Group Description) split by subjects with pure Left Bundle Branch Block (LBBB) and with other Conduction Disorders (NIVCD) for each pacing configuration CSP, BiV and CSPOT during acute protocol
Improvement in LV dP/dt Max by QRS Subgroup	At Implant during acute protocol	Percent change in LV dP/dt max (as described in Primary Outcome 2: Arm/Group Description) by QRS subgroup for each pacing configuration CSP, BiV and CSPOT during acute protocol. The QRS subgroups were subjects with QRS width greater than 171ms and QRS width less than or equal to 171ms as measured by 12-lead ECG

Trial Locations

Locations (12): Szpital Uniwersytecki w Krakowie
🇵🇱
Kraków, Poland
Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
🇵🇱
Katowice, Poland
University of South Florida
🇺🇸
Tampa, Florida, United States
Beacon Hospital
🇮🇪
Dublin, Ireland
The University of Chicago Medicine
🇺🇸
Chicago, Illinois, United States
Vanderbilt University Medical Center
🇺🇸
Nashville, Tennessee, United States
Cardiovascular Institute of the South
🇺🇸
Houma, Louisiana, United States
Medtronic Inc
🇺🇸
Mounds View, Minnesota, United States
Hospital of the University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Geisinger Wyoming Valley Medical Center
🇺🇸
Wilkes-Barre, Pennsylvania, United States
Hammersmith Hospital
🇬🇧
London, United Kingdom
Great Western Hospital
🇬🇧
Swindon, United Kingdom