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Conduction System Pacing Optimized Therapy | Clinical Trials | Clareo Health

COMPLETEDNA

Conduction System Pacing Optimized Therapy

Conduction System Pacing Optimized Therapy Study

NCT04905290•Medtronic Cardiac Rhythm and Heart Failure

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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
+6 more criteria

Locations (12)

University of South Florida

Tampa, Florida, 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

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Beacon Hospital

Dublin, Ireland

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

Katowice, Poland

Szpital Uniwersytecki w Krakowie

Krakow, Poland

Key Dates

Start Date

November 27, 2021

Primary Completion Date

April 18, 2023

Completion Date

November 2, 2023

Last Updated

April 15, 2025

Enrollment

ACTUAL participants

Conditions

Heart Failure

Interventions

Left ventricular coronary sinus (BiV) configuration

DEVICE

Conduction system pacing-only configuration

DEVICE

Conduction System Pacing Optimized Therapy (CSPOT) configuration

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Conduction System Pacing Optimized Therapy

Inclusion Criteria

Exclusion Criteria

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