Status:
COMPLETED
Conduction System Pacing Optimized Therapy
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 ve...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04905290
Start Date
November 27 2021
End Date
November 2 2023
Last Update
April 15 2025
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
University of South Florida
Tampa, Florida, United States, 33606
2
The University of Chicago Medicine
Chicago, Illinois, United States, 60637
3
Cardiovascular Institute of the South
Houma, Louisiana, United States, 70360
4
Medtronic Inc
Mounds View, Minnesota, United States, 55112