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Official title Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices
ClinicalTrials.gov ID: NCT06937658
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- Participation in another study related to novel CIED technology or remote monitoring.
See the full eligibility criteria
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.