Pacemaker DDDRAPTOR-CIEDNCT06937658
Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices
A study testing Alert-based care and Guideline-based care in people with Pacemaker DDD and Implantable Defibrillator User, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The 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 DDD, Implantable Defibrillator User
- What is being tested?
- Alert-based care and Guideline-based care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
The 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 Feasibility Phase of the study.
- Conditions
- Pacemaker DDD, Implantable Defibrillator User
- 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 careDevice
Alert-based care is an alternative strategy for longitudinal management of patients with wireless pacemakers and implantable defibrillators
Guideline-based careDevice
Guideline-based care is the current typical standard for longitudinal management of patients with wireless pacemakers and implantable defibrillators
| 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: Device: Guideline-based care |
| Alert-based Care | Active comparator | Remote monitoring programming scheduled for alert transmissions and patient-initiated transmissions only Receives: Device: Alert-based care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment
Number of patients enrolled and randomized per site and per month, and cumulatively
Measured: 6 months
Adherence
Proportion of cross-over
Measured: 6 months
Secondary outcomes (9)
Major adverse cardiac events
Incidence of MACE (i.e., death, stroke or systemic embolism, and unplanned cardiac device procedure)
Measured: 6 months
Major adverse cardiac events
Incidence of arrhythmia events, individual components of MACE, and health services use (i.e., hospital presentations)
Measured: 6 months
Effectiveness
Total number and type of device related encounters
Measured: 6 months
Effectiveness
Proportion of total device related encounters that are actionable (e.g., changes in programming or treatment)
Measured: 6 months
Connectivity
- Proportion of 24-, 48-, and 72-hour periods with versus without connected wireless monitoring
Measured: 6 months
Quality of Life and Health Status
EuroQol 5-dimensional questionnaire, five-level version (EQ-5D-5L) - 5 questions are scored from 1 to 5, with higher scores indicating worse outcomes
Measured: Baseline, 3 months, and 6 months
Quality of Life and Health Status
Cardiac Anxiety Questionnaire (CAQ) - scored from 0 to 72, with a higher score corresponding to higher cardiac anxiety
Measured: Baseline, 3 months, and 6 months
Quality of Life and Health Status
Patient Health Questionnaire depression scale (PHQ-8) - scored from 0 to 24, with a higher score indicating worse symptoms
Measured: Baseline, 3 months, and 6 months
Quality of Life and Health Status
Patient Activation Measure (PAM) - scored from 0 to 100, with a higher score indicating better outcomes
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start1 May 2025
- Primary completion1 Aug 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pacemaker DDDStudies 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
- 120 participants (actual)
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
- NCT06937658
- Sponsor's protocol ID
- PLACER-2023C3-34968
- Acronym
- RAPTOR-CIED
- Status last verified
- Oct 2026
- First submitted
- 8 Apr 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 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
- ClinicalTrials.gov ID
- NCT06937658
- Acronym / sponsor ID
- RAPTOR-CIED / PLACER-2023C3-34968
- Conditions
- Pacemaker DDD, Implantable Defibrillator User
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 22 Apr 2025 (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 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 Feasibility 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 | Device: 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 | Device: Alert-based careRemote monitoring programming scheduled for alert transmissions and patient-initiated transmissions only |
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 | Device | Alert-based Care |
| Guideline-based careGuideline-based care is the current typical standard for longitudinal management of patients with wireless pacemakers and implantable defibrillators | Device | Guideline-based Care |
Primary outcome
Enrollment
Time frame: 6 months
Number of patients enrolled and randomized per site and per month, and cumulatively
Adherence
Time frame: 6 months
Proportion of cross-over
9 secondary outcomes
Major adverse cardiac events
Time frame: 6 months
Major adverse cardiac events
Time frame: 6 months
Effectiveness
Time frame: 6 months
Effectiveness
Time frame: 6 months
Connectivity
Time frame: 6 months
Quality of Life and Health Status
Time frame: Baseline, 3 months, and 6 months
Quality of Life and Health Status
Time frame: Baseline, 3 months, and 6 months
Quality of Life and Health Status
Time frame: Baseline, 3 months, and 6 months
Quality of Life and Health Status
Time frame: Baseline, 3 months, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Pacemaker DDD
RecruitingObservational study
Prospective Database for Prediction of Atrial Fibrillation in Pacemaker and ICD Patients
Atrial Fibrillation, Pacemaker Ddd
RecruitingObservational study
Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy
Heart Failure, Pacemaker DDD
RecruitingObservational study
Left Bundle Branch Area Mapping for Conduction System Pacing
Left Bundle-Branch Block, Pacemaker DDD
Active, not recruitingPhase 4
The Leadless AV Versus DDD Pacing Study
Cardiac Pacemaker, Arrhythmias, Cardiac
Active, not recruiting
Danish Randomized Trial on Leadless vs Transvenous Pacing
AV Block
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?
A study testing Alert-based care and Guideline-based care in people with Pacemaker DDD and Implantable Defibrillator User, 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: finished, as of the sponsor's last update on 30 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Enrollment (time frame: 6 months). 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 30 Oct 2026.