Clinical trial NCT04905290: Conduction System Pacing Optimized Therapy
Official title: Conduction System Pacing Optimized Therapy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2021-05-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Electrical Synchronization Response
timeFrame: At implant during acute protocol
measure: Hemodynamic Response
timeFrame: At implant during acute protocol
Secondary outcomes:
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: Baseline and 6 months
measure: Left Ventricular End Systolic Volume (LVESV)
timeFrame: Baseline and 6 months
measure: Clinical Composite Score (CCS)
timeFrame: 6 months
measure: Absolute Percent Change in SDAT by QRS Subgroup
timeFrame: At Implant during acute protocol
measure: Absolute Percent Change in SDAT Split by Subjects With Pure LBBB and With Other Conduction Disorders
timeFrame: At Implant during acute protocol
measure: Absolute Percent Change in SDAT Split by Subjects With Ischemic Cardiomyopathy and Those With Non-Ischemic Cardiomyopathy
timeFrame: At Implant during acute protocol
measure: Percent Change in LV dP/dt Max Split by Subjects With Ischemic Cardiomyopathy and Those With Non-Ischemic Cardiomyopathy
timeFrame: At Implant during acute protocol
measure: Percent Change in LV dP/dt Max Split by Subjects With Pure Left Bundle Branch Block (LBBB) and With Other Conduction Disorders (NIVCD)
timeFrame: At Implant during acute protocol
measure: Improvement in LV dP/dt Max by QRS Subgroup
timeFrame: At Implant during acute protocol
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Chicago
country: United States
facility: The University of Chicago Medicine
state: Illinois
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Mounds View
country: United States
facility: Medtronic Inc
state: Minnesota
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dublin
country: Ireland
facility: Beacon Hospital
city: Katowice
country: Poland
facility: Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
city: Kraków
country: Poland
facility: Szpital Uniwersytecki w Krakowie
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: Swindon
country: United Kingdom
facility: Great Western Hospital
Study officials:
References: