Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conduction system pacing | Medicare beneficiaries indicated for CRT implanted with a Medtronic dual-chamber transvenous pacemaker on or after the study start date with lead type and placement data indicating conduction system pacing. |
| |
| Bi-ventricular pacing | Medicare beneficiaries indicated for CRT implanted with a Medtronic bi-ventricular pacemaker (CRT-P) on or after the study start date with lead type and placement data not indicating conduction system pacing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conduction system pacing | Device | Implant with a Medtronic dual-chamber transvenous pacemaker on or after the study data with lead type and placement data indicating conduction system pacing |
| Measure | Description | Time Frame |
|---|---|---|
| Acute complication rate | 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). | 30 days |
| Heart Failure Hospitalization Rate | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Device-Related Reintervention Rate | Compare the device-related reintervention rate associated with dual chamber CSP vs. BVP. | 12 months |
| Heart Failure-All-Cause Mortality Composite | 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. |
Not provided
Inclusion Criteria:
Dual-chamber CSP cohort:
BVP comparator cohort:
Exclusion Criteria:
Dual-chamber CSP cohort:
BVP comparator cohort:
Not provided
Not provided
Not provided
Not provided
The study cohort will include all U.S. Medicare beneficiaries enrolled in fee-for-service Medicare implanted with a Medtronic pacemaker between January 1, 2017 and December 1, 2023.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medtronic | Mounds View | Minnesota | 55112 | United States |
Sharing individual participant data is not permitted under the data use agreement with the Centers for Medicare and Medicaid Services (CMS) which allows us to access the Medicare data for research purposes.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Bi-ventricular pacing | Device | Implant with a Medtronic bi-ventricular pacemaker (CRT-P) on or after the study date |
|
| 12 months |
| All-Cause Mortality Rate | Compare the all-cause mortality rate associated with dual-chamber CSP use vs. BVP in the CRT-indicated population. | 12 months |