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Conduction System Pacing Optimized Therapy (CSPOT)

Primary Purpose

Heart Failure

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Left ventricular coronary sinus configuration
Conduction system pacing-only configuration
Conduction System Pacing Optimized Therapy (CSPOT) configuration
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of South Florida
  • The University of Chicago Medicine
  • Cardiovascular Institute of the South
  • Medtronic Inc
  • Hospital of the University of Pennsylvania
  • Geisinger Wyoming Valley Medical Center
  • Vanderbilt University Medical Center
  • Beacon Hospital
  • Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
  • Szpital Uniwersytecki w Krakowie
  • Hammersmith Hospital
  • Great Western Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Electrical synchronization response
Standard Deviation of Activation Times (SDAT), a measurement of dyssynchrony, taken by the ECG belt, a diagnostic tool used to provide feedback and additional information on the CRT pacing at the time of the device implant or at a device follow up.
Hemodynamic response
For each intervention (i.e. left ventricular coronary sinus, conduction system only, and conduction system pacing optimized therapy), the pacing will switch back and forth between the intervention's pacing configuration and an atrial-only pacing configuration for several repetitions. For each repetition, left ventricular (LV) dP/dt max, a measurement of the initial velocity of myocardial contraction, will be measured for both configurations, and the median value across repetitions will be found for each configuration. Finally, the percent change in LV dP/dt max will be calculated as the difference between the median value from the intervention's pacing configuration and the median value from atrial-only pacing, divided by the median value from atrial-only pacing. This percent change will be used as the measurement of hemodynamic response for the given intervention.

Secondary Outcome Measures

Left ventricular ejection fraction (LVEF)
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)
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)
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"

Full Information

First Posted
May 24, 2021
Last Updated
October 17, 2023
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT04905290
Brief Title
Conduction System Pacing Optimized Therapy
Acronym
CSPOT
Official Title
Conduction System Pacing Optimized Therapy Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 27, 2021 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Left ventricular coronary sinus configuration
Intervention Description
For subjects with a pacemaker, pacing of the left ventricular coronary sinus only. For subjects with a defibrillator, biventricular pacing of the left ventricular coronary sinus and the right ventricle.
Intervention Type
Device
Intervention Name(s)
Conduction system pacing-only configuration
Intervention Description
Conduction system pacing (CSP) of the left bundle branch.
Intervention Type
Device
Intervention Name(s)
Conduction System Pacing Optimized Therapy (CSPOT) configuration
Intervention Description
A combination of left ventricle (LV) pacing and conduction system pacing (CSP) of the left bundle branch.
Primary Outcome Measure Information:
Title
Electrical synchronization response
Description
Standard Deviation of Activation Times (SDAT), a measurement of dyssynchrony, taken by the ECG belt, a diagnostic tool used to provide feedback and additional information on the CRT pacing at the time of the device implant or at a device follow up.
Time Frame
At implant
Title
Hemodynamic response
Description
For each intervention (i.e. left ventricular coronary sinus, conduction system only, and conduction system pacing optimized therapy), the pacing will switch back and forth between the intervention's pacing configuration and an atrial-only pacing configuration for several repetitions. For each repetition, left ventricular (LV) dP/dt max, a measurement of the initial velocity of myocardial contraction, will be measured for both configurations, and the median value across repetitions will be found for each configuration. Finally, the percent change in LV dP/dt max will be calculated as the difference between the median value from the intervention's pacing configuration and the median value from atrial-only pacing, divided by the median value from atrial-only pacing. This percent change will be used as the measurement of hemodynamic response for the given intervention.
Time Frame
At implant
Secondary Outcome Measure Information:
Title
Left ventricular ejection fraction (LVEF)
Description
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.
Time Frame
Baseline and 6 months
Title
Left ventricular end systolic volume (LVESV)
Description
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.
Time Frame
Baseline and 6 months
Title
Clinical Composite Score (CCS)
Description
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"
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
The University of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Cardiovascular Institute of the South
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Medtronic Inc
City
Mounds View
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Geisinger Wyoming Valley Medical Center
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Beacon Hospital
City
Dublin
ZIP/Postal Code
D18 Ak68
Country
Ireland
Facility Name
Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
City
Katowice
ZIP/Postal Code
40-635
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie
City
Kraków
ZIP/Postal Code
30-688
Country
Poland
Facility Name
Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Great Western Hospital
City
Swindon
ZIP/Postal Code
SN3 6BB
Country
United Kingdom

12. IPD Sharing Statement

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Conduction System Pacing Optimized Therapy

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