Heart FailureCORE-CPPNCT06606288
Characterizing Outcomes and Real-World Experience of Cardiac Physiologic Pacing (The CORE-CPP Study)
An observational study of Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- Conduction system pacing and Bi-ventricular pacing
- Type of treatment
- Medical device
- How many people
- 6,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Heart Failure
- Being tested
- Conduction system pacing, Bi-ventricular pacing
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conduction system pacingDevice
Implant with a Medtronic dual-chamber transvenous pacemaker on or after the study data with lead type and placement data indicating conduction system pacing
Bi-ventricular pacingDevice
Implant with a Medtronic bi-ventricular pacemaker (CRT-P) on or after the study date
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: 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. Receives: Device: Bi-ventricular pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 12 months
Secondary outcomes (3)
Device-Related Reintervention Rate
Compare the device-related reintervention rate associated with dual chamber CSP vs. BVP.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start1 Jan 2017
- Primary completion31 Dec 2023
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606288
- Sponsor's protocol ID
- 30489333
- Acronym
- CORE-CPP
- Status last verified
- Apr 2026
- First submitted
- 18 Sep 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Outcomes and Real-World Experience of Cardiac Physiologic Pacing (The CORE-CPP Study)
- ClinicalTrials.gov ID
- NCT06606288
- Acronym / sponsor ID
- CORE-CPP / 30489333
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conduction system pacing | – | Device: Conduction system pacingMedicare 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 | – | Device: Bi-ventricular pacingMedicare 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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.
- Medicare beneficiaries implanted with a Medtronic biventricular pacemaker (CRT-P) on or after the study start date.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conduction system pacingImplant with a Medtronic dual-chamber transvenous pacemaker on or after the study data with lead type and placement data indicating conduction system pacing | Device | Conduction system pacing |
| Bi-ventricular pacingImplant with a Medtronic bi-ventricular pacemaker (CRT-P) on or after the study date | Device | Bi-ventricular pacing |
Primary outcome
Acute complication rate
Time frame: 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
Time frame: 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.
3 secondary outcomes
Device-Related Reintervention Rate
Time frame: 12 months
Heart Failure-All-Cause Mortality Composite
Time frame: 12 months
All-Cause Mortality Rate
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute complication rate (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.