Rhythmia Mapping System for Arrhythmia
(RHAPSODY Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new software features in the Rhythmia Mapping System, used during heart procedures for irregular heartbeats, known as tachyarrhythmias. The goal is to evaluate the performance of these features and enhance future software. It involves patients already scheduled for a standard catheter procedure to map heart rhythms. Individuals dealing with atrial or ventricular tachyarrhythmias (fast or irregular heartbeats) and set for endocardial mapping might be suitable for this trial. As a Phase 2 trial, the research measures the effectiveness of the new software features in an initial, smaller group, offering participants a chance to contribute to advancements in heart rhythm mapping technology.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What prior data suggests that this software is safe for use in catheter-based endocardial mapping?
Research has shown that the Rhythmia Mapping System is generally safe for patients undergoing heart mapping procedures. Studies have found it effective for mapping irregular heartbeats in both the upper and lower parts of the heart.
One study demonstrated its safety and effectiveness in everyday medical settings. Another study confirmed its safety and accuracy, even for children. These studies suggest that the Rhythmia Mapping System typically does not cause serious side effects.
Overall, the evidence supports the safety of the Rhythmia Mapping System for its intended use in heart mapping procedures.12345Why are researchers excited about this trial?
The Rhythmia Mapping System is unique because it offers a more precise and detailed way to map the heart's electrical activity compared to current options. Unlike traditional methods, which can be less detailed, this system uses advanced technology to create high-definition maps of the heart, allowing doctors to better pinpoint areas that cause irregular heartbeats. Researchers are excited about this treatment because it could lead to more accurate diagnoses and improved outcomes for patients with complex arrhythmias.
What evidence suggests that the Rhythmia Mapping System is effective for catheter-based endocardial mapping?
Research has shown that the Rhythmia Mapping System, which all participants in this trial will receive, effectively treats various heart rhythm problems. Studies have reported success rates ranging from 61.5% to 100% in different clinical settings. Specifically, one study found success in up to 95.7% of certain heart rhythm cases, while another reported an 83.3% success rate in 420 patients. These high success rates suggest that the Rhythmia Mapping System is a reliable option for managing heart rhythm issues.678910
Who Is on the Research Team?
Thomas H McElderry, MD
Principal Investigator
University of Alabama at Birmingham
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo standard of care catheter-based endocardial mapping and ablation treatments for tachyarrhythmias using the Rhythmia Mapping System
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Rhythmia Mapping System
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All subjects are included in this cohort and are treated with the Rhythmia Mapping System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Scientific Corporation
Lead Sponsor
Michael F. Mahoney
Boston Scientific Corporation
Chief Executive Officer since 2016
MBA from Wake Forest University, BBA in Finance from the University of Iowa
Kenneth Stein
Boston Scientific Corporation
Chief Medical Officer since 2020
MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology
Citations
Efficacy of Commonly Used 3D Mapping Systems in Acute ...
The acute success rate using the Rhythmia system ranged from 61.5 to 100.0% for different clinical settings. Conclusions: Mapping systems have played a crucial ...
2.
news.bostonscientific.com
news.bostonscientific.com/2018-03-20-Late-breaking-Clinical-Trial-Data-Further-Demonstrate-Safety-and-Effectiveness-of-the-RHYTHMIA-TM-Mapping-SystemLate-breaking Clinical Trial Data Further Demonstrate ...
Depending on the arrhythmia type, study data showed an acute success rate of up to 95.7%. In 222 patients, procedure process included the ...
3.
touchcardio.com
touchcardio.com/arrhythmia/journal-articles/efficacy-of-commonly-used-3d-mapping-systems-in-acute-success-rates-of-catheter-ablation-procedures/Efficacy of Commonly Used 3D Mapping Systems in Acute ...
The acute success rate using the Rhythmia system ranged from 61.5 to 100.0% for different clinical settings. Conclusions. Mapping systems have ...
Acute safety, effectiveness, and real-world clinical usage of ...
Four hundred and twenty treated patients resulted in a successful procedure confirmed by arrhythmia-specific validation techniques (83.3%; 95% ...
A new mapping method with the Rhythmia™ navigation ...
Here, we report on the feasibility and safety of a novel non-fluoroscopic approach (NFA) that uses the Rhythmia ™ mapping system and a novel navigation-enabled ...
6.
bostonscientific.com
bostonscientific.com/en-US/products/capital-equipment--mapping-and-navigation/rhythmia-mapping-system/rhythmia-indications.htmlRHYTHMIA HDx™ Indications, Safety and Warnings
The RHYTHMIA HDx is for catheter-based atrial and ventricular mapping, but not for life-sustaining pacing. Verify catheter position and avoid RF power ...
SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)
The warnings and precautions can be found in the INTELLANAV STABLEPOINT™. Ablation Catheter & Force Sensing System on the RHYTHMIA HDX™ Mapping.
Acute safety, effectiveness, and real-world clinical usage of ...
The objective of this study was to verify acute safety, performance, and usage of a novel ultra-high density mapping system in patients undergoing ablation ...
527Safety and acute effectiveness of the 3D RHYTHMIA ...
This data supports the safety and effectiveness of RHYTHMIA mapping system and the INTELLAMAP ORION mapping catheter. Published on behalf of the ...
Safety and accuracy of the Rhythmia mapping system in ...
The Orion catheter and Rhythmia mapping system were safe and accurate for mapping various arrhythmias in pediatric patients. Detailed geometry and high- ...
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