Conduction System Pacing Optimized Therapy

Heart Failure Clinical Trial

— CSPOT  

Official title:

Conduction System Pacing Optimized Therapy Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04905290
• Other study ID #: MDT20029
• Status: Completed
• Phase: N/A
• Start date: November 27, 2021
• Est. completion date: January 25, 2024

Study information

• Verified date: October 2023
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 25, 2024
• Est. primary completion date: November 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Ireland	Beacon Hospital	Dublin
Poland	Górnoslaskie Centrum Medyczne im prof Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach	Katowice
Poland	Szpital Uniwersytecki w Krakowie	Kraków
United Kingdom	Hammersmith Hospital	London
United Kingdom	Great Western Hospital	Swindon
United States	The University of Chicago Medicine	Chicago	Illinois
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	Medtronic Inc	Mounds View	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of South Florida	Tampa	Florida
United States	Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

United States,  Ireland,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At implant
Primary	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.	At implant
Secondary	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.	Baseline and 6 months
Secondary	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.	Baseline and 6 months
Secondary	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"	6 months