Heart Failure
Conditions
Brief summary
The purpose of this study is to use real-world evidence to validate that conduction system pacing (CSP), delivered via a Medtronic 3830 catheter-delivered lead and a Medtronic dual-chamber transvenous pacemaker, is a safe and effective alternative to biventricular pacing (BVP) in patients indicated for cardiac resynchronization therapy (CRT) to deliver cardiac physiologic pacing (CPP), as documented in the clinical literature.
Interventions
DEVICEConduction system pacing
Implant with a Medtronic dual-chamber transvenous pacemaker on or after the study data with lead type and placement data indicating conduction system pacing
DEVICEBi-ventricular pacing
Implant with a Medtronic bi-ventricular pacemaker (CRT-P) on or after the study date
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Dual-chamber CSP cohort: * Medicare beneficiaries implanted with a Medtronic dual-chamber transvenous pacemaker on or after the study start date. * Lead type and placement data indicating CSP. * An indication for CRT. BVP comparator cohort: * Medicare beneficiaries implanted with a Medtronic biventricular pacemaker (CRT-P) on or after the study start date.
Exclusion criteria
Dual-chamber CSP cohort: * Evidence of a prior CIED device. * Less than 12 months continuous enrollment in Medicare Part A and Part B prior to implant date. * Non-Medtronic pacemaker (unable to link to Medtronic device registration data). * Missing lead type or placement data. * Lead type and placement data indicating non-CSP placement. BVP comparator cohort: * Evidence of a prior CIED device. * Less than 12 months continuous enrollment in Medicare Part A and Part B prior to implant date. * Non-Medtronic pacemaker (unable to link to Medtronic device registration data). * Missing lead type or placement data.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute complication rate | 30 days | Demonstrate that dual-chamber CSP is non-inferior to BVP on implant safety in patients indicated for CRT. Endpoint: Compare the acute (≤ 30 days) overall complication rate associated with dual chamber CSP vs. BVP. The acute overall complication rate is a composite measure of separate elements of complications (embolism and thrombosis, events at puncture site, cardiac effusion and perforation, device-related complications, and other procedural complications) and reinterventions (lead-related reinterventions, device revisions, replacements, removals, and upgrades to CRT). |
| Heart Failure Hospitalization Rate | 12 months | Demonstrate that dual-chamber CSP is non-inferior to BVP in patients indicated for CRT. Endpoint: Compare the heart failure hospitalization rate associated with CSP vs. BVP in the CRT-indicated population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device-Related Reintervention Rate | 12 months | Compare the device-related reintervention rate associated with dual chamber CSP vs. BVP. |
| Heart Failure-All-Cause Mortality Composite | 12 months | Compare the composite endpoint of heart failure hospitalization or all-cause mortality rate associated with dual=chamber CSP use vs. BVP in the CRT-indicated population. |
| All-Cause Mortality Rate | 12 months | Compare the all-cause mortality rate associated with dual-chamber CSP use vs. BVP in the CRT-indicated population. |
Countries
United States
Outcome results
None listed