PacemakerRAPTOR - MAINNCT07352657
Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices: The RAPTOR-CIED Study (Main Phase)
A study testing Alert-based care and Guideline-based Care in people with Pacemaker and Implantable Defibrillator, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
he Remote Alert Pathway to Optimize Care of Cardiac Implantable Electrical Devices (RAPTOR-CIED) Study is a pragmatic, multi-center, randomized trial with 1:1 patient-level randomization comparing the safety and effectiveness of alert-driven care versus guideline-based care for patients with wireless cardiac… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacemaker, Implantable Defibrillator
- What is being tested?
- Alert-based care and Guideline-based Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 31 Jan 2031
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult aged > 18 years
- Clinically stable by investigator assessment
- Has a newly implanted or existing wireless CIED: single, dual-chamber, biventricular, subcutaneous/extravascular, and leadless systems are all eligible, including pacemakers or implantable cardioverter-defibrillators (ICDs)
- CIED is from one of the 4 major CIED manufacturers in the US market (99% of implants in the US): Medtronic, Boston Scientific, Abbott, Biotronik
- Currently enrolled in remote monitoring as part of standard of care
- Primary clinical electrophysiology follow-up at the enrolling center
- Understands spoken and written English, Spanish, or Portuguese
- Has sufficient cognitive function to answer standardized questions about study rationale and procedures.
Who cannot join
- Presence of insertable cardiac monitor, either in isolation or in combination with any other CIED
- Listed for cardiac transplantation prior to enrollment (N.B. if a patient becomes listed for transplantation during the study, they may continue study participation)
- Participation in another study related to novel CIED technology or remote monitoring.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
he Remote Alert Pathway to Optimize Care of Cardiac Implantable Electrical Devices (RAPTOR-CIED) Study is a pragmatic, multi-center, randomized trial with 1:1 patient-level randomization comparing the safety and effectiveness of alert-driven care versus guideline-based care for patients with wireless cardiac implantable electrical devices (CIEDs).
The study will be conducted in 2 phases: a Feasibility Phase and a Main Phase. This registration outlines the goals and design features of the Main Phase of the study.
- Conditions
- Pacemaker, Implantable Defibrillator
- Being tested
- Alert-based care, Guideline-based Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alert-based careOther
Alert-based care is an alternative strategy for longitudinal management of patients with wireless pacemakers and implantable defibrillators
Guideline-based CareOther
Remote monitoring programming scheduled for alert transmissions, patient-initiated transmissions, and routine transmissions (scheduled to occur every 90 days from the date of enrollment in the study); in-office interrogations on at least an annual basis
| Study group | Role | What they receive |
|---|---|---|
| Guideline-based Care | Active comparator | Remote monitoring programming scheduled for alert transmissions, patient-initiated transmissions, and routine transmissions (scheduled to occur every 90 days from the date of enrollment in the study); in-office interrogations on at least an annual basis Receives: Other: Guideline-based Care |
| Alert-based care | Active comparator | Alert-based care is an alternative strategy for longitudinal management of patients with wireless pacemakers and implantable defibrillators Receives: Other: Alert-based care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events
Incidence of MACE (i.e., death, stroke or systemic embolism, and unplanned cardiac device procedure)
Measured: 2 years
Effectiveness
Proportion of total device related encounters that are actionable (e.g., changes in programming or treatment)
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PacemakerStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Daniel B. Kramer, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352657
- Sponsor's protocol ID
- 2025P001064
- Acronym
- RAPTOR - MAIN
- Status last verified
- Feb 2026
- First submitted
- 12 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices: The RAPTOR-CIED Study (Main Phase)
- ClinicalTrials.gov ID
- NCT07352657
- Acronym / sponsor ID
- RAPTOR - MAIN / 2025P001064
- Conditions
- Pacemaker, Implantable Defibrillator
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Jan 2031 (estimated)
- First posted
- 20 Jan 2026 (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.
he Remote Alert Pathway to Optimize Care of Cardiac Implantable Electrical Devices (RAPTOR-CIED) Study is a pragmatic, multi-center, randomized trial with 1:1 patient-level randomization comparing the safety and effectiveness of alert-driven care versus guideline-based care for patients with wireless cardiac implantable electrical devices (CIEDs).
The study will be conducted in 2 phases: a Feasibility Phase and a Main Phase. This registration outlines the goals and design features of the Main Phase of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guideline-based Care | Active comparator | Other: Guideline-based CareRemote monitoring programming scheduled for alert transmissions, patient-initiated transmissions, and routine transmissions (scheduled to occur every 90 days from the date of enrollment in the study); in-office interrogations on at least an annual basis |
| Alert-based care | Active comparator | Other: Alert-based careAlert-based care is an alternative strategy for longitudinal management of patients with wireless pacemakers and implantable defibrillators |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult aged > 18 years
- Clinically stable by investigator assessment
- Has a newly implanted or existing wireless CIED: single, dual-chamber, biventricular, subcutaneous/extravascular, and leadless systems are all eligible, including pacemakers or implantable cardioverter-defibrillators (ICDs)
- CIED is from one of the 4 major CIED manufacturers in the US market (99% of implants in the US): Medtronic, Boston Scientific, Abbott, Biotronik
- Currently enrolled in remote monitoring as part of standard of care
Key exclusion criteria (3 listed)
- Presence of insertable cardiac monitor, either in isolation or in combination with any other CIED
- Listed for cardiac transplantation prior to enrollment (N.B. if a patient becomes listed for transplantation during the study, they may continue study participation)
- Participation in another study related to novel CIED technology or remote monitoring.
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 |
|---|---|---|
| Alert-based careAlert-based care is an alternative strategy for longitudinal management of patients with wireless pacemakers and implantable defibrillators | Other | Alert-based care |
| Guideline-based CareRemote monitoring programming scheduled for alert transmissions, patient-initiated transmissions, and routine transmissions (scheduled to occur every 90 days from the date of enrollment in the study); in-office interrogations on at least an annual basis | Other | Guideline-based Care |
Primary outcome
Major adverse cardiac events
Time frame: 2 years
Incidence of MACE (i.e., death, stroke or systemic embolism, and unplanned cardiac device procedure)
Effectiveness
Time frame: 2 Years
Proportion of total device related encounters that are actionable (e.g., changes in programming or treatment)
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 6 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alert-based care and Guideline-based Care in people with Pacemaker and Implantable Defibrillator, run by Beth Israel Deaconess Medical Center 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 8 inclusion and 3 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: opening soon, as of the sponsor's last update on 6 Feb 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?
Contact Daniel B Kramer, MD, MPH (617-667-8800, dkramer@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac events (time frame: 2 years). 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 6 Feb 2026.