Conduction System Pacing Optimized Therapy

NCT04905290 | Completed Results FDA Device

• 1 other identifier: MDT20029
• Study Type: interventional
• Target: 60
• Locations: 4 countries
• Sites: 12

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• Electrical Synchronization Response

  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.

  At implant during acute protocol

• Hemodynamic Response

  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.

  At implant during acute protocol

Secondary Outcomes (9)

• Left Ventricular Ejection Fraction (LVEF)

  Baseline and 6 months

• Left Ventricular End Systolic Volume (LVESV)

  Baseline and 6 months

• Clinical Composite Score (CCS)

  6 months

• Absolute Percent Change in SDAT by QRS Subgroup

  At Implant during acute protocol

• Absolute Percent Change in SDAT Split by Subjects With Pure LBBB and With Other Conduction Disorders

  At Implant during acute protocol

Study Arms (1)

Single Arm

EXPERIMENTAL

Patients will undergo 1) Conduction System Pacing Optimized Therapy (CSPOT) lead placement, then the 2) acute pacing protocol, and then 3) device implant. During the acute pacing protocol (step 2), all patients will undergo three types of pacing configurations and for each pacing configuration several delay settings, as defined in Assigned Interventions. For each intervention, defined as a unique combination of pacing configuration and delay setting, the protocol will alternate for several heartbeats between AV pacing and intervention (5 sections of AV pacing and 4 sections of intervention). For each set of 9, Left Ventricular dP/dt max will be calculated continuously, and Standard Deviation of Activation Time will be selected from one of the sections for atrial-only pacing and one of the intervention sections. Device implant (step 3) will be with either a CRT-D or CRT-P. Each patient's device will be programmed to CSPOT pacing. Patients will be followed for 6 months.

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

Interventions

Left ventricular coronary sinus (BiV) configuration DEVICE

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. During the acute protocol, the five AV delays for this intervention include the default AV delay setting, default + 30 milliseconds (ms) AV delay, default + 60 ms AV delay, default - 30ms AV delay, default - 60ms AV delay. Patients with a defibrillator will receive two additional delays LV precedes default by 30ms and LV precedes default by 60ms.

Single Arm

Conduction system pacing-only configuration DEVICE

Conduction System Pacing (CSP) of the left bundle branch. During the acute protocol, the five AV delays for this intervention include the default AV delay setting, default + 30 milliseconds (ms) AV delay, default + 60 ms AV delay, default - 30ms AV delay, and default - 60ms AV delay.

Single Arm

Conduction System Pacing Optimized Therapy (CSPOT) configuration DEVICE

A combination of Left Ventricle pacing and Conduction System Pacing of the left bundle branch. During the acute protocol, the eight delays for this intervention include the default AV delay setting, default + 30 milliseconds (ms) AV delay, default + 60 ms AV delay, default - 30ms AV delay, default - 60ms AV delay, CSP precedes default by 30ms, LV precedes default by 30ms and LV precedes default by 60ms.

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (12)

University of South Florida

Tampa, Florida, 33606, United States

Location

The University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

Medtronic Inc

Mounds View, Minnesota, 55112, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Beacon Hospital

Dublin, D18 Ak68, Ireland

Location

Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach

Katowice, 40-635, Poland

Location

Szpital Uniwersytecki w Krakowie

Krakow, 30-688, Poland

Location

Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

Great Western Hospital

Swindon, SN3 6BB, United Kingdom

Location

Related Publications (1)

• Jastrzebski M, Foley P, Chandrasekaran B, Whinnett Z, Vijayaraman P, Upadhyay GA, Schaller RD, Gardas R, Richardson T, Kudlik D, Stadler RW, Zimmerman P, Burrell J, Waxman R, Cornelussen RN, Lyne J, Herweg B. Multicenter Hemodynamic Assessment of the LOT-CRT Strategy: When Does Combining Left Bundle Branch Pacing and Coronary Venous Pacing Enhance Resynchronization?: Primary Results of the CSPOT Study. Circ Arrhythm Electrophysiol. 2024 Nov;17(11):e013059. doi: 10.1161/CIRCEP.124.013059. Epub 2024 Oct 23.

  PMID: 39440428 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: James Burrell, Senior Statistician
• Organization: Medtronic

burrej3@medtronic.com

18006338766

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: May 27, 2021
• Study Start: November 27, 2021
• Primary Completion: April 18, 2023
• Study Completion: November 2, 2023
• Last Updated: April 15, 2025
• Results First Posted: January 17, 2025

Record last verified: 2023-10

Locations

IE (1); GB (2); US (7); PL (2)