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Conduction System Pacing Optimized Therapy (CSPOT)

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ClinicalTrials.gov Identifier: NCT04905290
Recruitment Status : Recruiting
First Posted : May 27, 2021
Last Update Posted : December 28, 2021
Sponsor:
Information provided by (Responsible Party):
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 (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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Left ventricular coronary sinus configuration Device: Conduction system pacing-only configuration Device: Conduction System Pacing Optimized Therapy (CSPOT) configuration Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Conduction System Pacing Optimized Therapy Study
Actual Study Start Date : November 27, 2021
Estimated Primary Completion Date : April 15, 2023
Estimated Study Completion Date : April 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Single Arm
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.
Device: Left ventricular coronary sinus configuration
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.

Device: Conduction system pacing-only configuration
Conduction system pacing (CSP) of the left bundle branch.

Device: Conduction System Pacing Optimized Therapy (CSPOT) configuration
A combination of left ventricle (LV) pacing and conduction system pacing (CSP) of the left bundle branch.




Primary Outcome Measures :
  1. Electrical synchronization response [ Time Frame: At implant ]
    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.

  2. Hemodynamic response [ Time Frame: At implant ]
    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 :
  1. Left ventricular ejection fraction (LVEF) [ Time Frame: 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.

  2. Left ventricular end systolic volume (LVESV) [ Time Frame: 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.

  3. Clinical Composite Score (CCS) [ Time Frame: 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"



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04905290


Contacts
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Contact: Rachael Rose 7635262332 rachael.k.rose@medtronic.com
Contact: Joy A Aso 4015454454 joy.a.aso@medtronic.com

Locations
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United States, Minnesota
Medtronic Inc Recruiting
Mounds View, Minnesota, United States, 55112
Contact: Rachael Rose    651-332-1366    rachael.k.rose@medtronic.com   
Contact: Joy A Aso    4015454454    joy.a.aso@medtronic.com   
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT04905290    
Other Study ID Numbers: MDT20029
First Posted: May 27, 2021    Key Record Dates
Last Update Posted: December 28, 2021
Last Verified: December 2021

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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
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases