AtriCure Devices for Rapid Heart Rate
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to gather safety and performance data on AtriCure devices used to treat Inappropriate Sinus Tachycardia (IST) and Postural Tachycardia Syndrome (POTS). IST causes an abnormally fast heartbeat, while POTS affects blood flow, leading to dizziness or fainting when standing. The trial will collect real-world information from both past and future procedures. Participants may qualify if they are scheduled for, or have already undergone, a procedure using these devices for IST or POTS. As a Phase 4 trial, this research seeks to understand how the FDA-approved and proven effective treatment benefits more patients.
What prior data suggests that these AtriCure devices are safe for treating rapid heart rate?
Research has shown that AtriCure devices, used to treat irregular heartbeats, have some safety information available. Studies reported fluid buildup around the heart as the most common issue, occurring in about 25% of cases. Stroke was another concern, occurring in around 18% of cases. These factors are important to consider when deciding to join a trial involving these devices. However, these devices are already used for other heart conditions, providing some experience with them. Weighing the known risks against the potential benefits is crucial when making a decision.12345
Why are researchers excited about this trial?
Researchers are excited about the Inappropriate Sinus Tachycardia (IST) Registry because it aims to gather comprehensive data on this condition, which could lead to better understanding and treatment options. Currently, treatments for IST, like beta-blockers or calcium channel blockers, often have limited effectiveness and can cause side effects. By collecting detailed patient information, the registry hopes to identify patterns and potential new targets for therapy. This could pave the way for more personalized and effective treatments in the future, addressing a significant gap in current heart rate management strategies.
What evidence suggests that AtriCure devices are effective for rapid heart rate?
Studies have shown that AtriCure devices effectively treat certain heart rhythm problems. One study successfully treated persistent atrial fibrillation (a condition where the heart beats irregularly and often too fast) in 67.7% of patients after one year. Another study found a 66.2% success rate at 12 months, even for patients requiring extra medication. These devices restore normal heart rhythm by destroying small areas of heart tissue and have proven safe and effective in difficult cases. Early research suggests they may also be a promising option for managing fast heart rates in conditions like Inappropriate Sinus Tachycardia (IST) and Postural Tachycardia Syndrome (POTS).678910
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 cardiac ablation procedures using AtriCure devices for IST or POTS
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Find a Clinic Near You
Who Is Running the Clinical Trial?
AtriCure, Inc.
Lead Sponsor
Citations
Hybrid AF Therapy Clinical Data | CONVERGE Trial Results
Hybrid convergent ablation performed in routine clinical practice continues to be safe and effective in a historically difficult-to-treat patient population.
2.
ir.atricure.com
ir.atricure.com/news-releases/news-release-details/atricure-announces-results-converge-ide-clinical-trialAtriCure Announces Results from CONVERGE IDE Clinical ...
Dr. DeLurgio presented the MAE rate of 7.8% in treatment arm, which was lower than the protocol pre-specified performance goal of 12%. There ...
Three-year outcomes of the postapproval study ...
The primary success, which factored in failure due to antiarrhythmic drugs, was 66.2% (184/278) (95% CI, 60.3-71.7) at 12 months; 64.9% (159/245) ...
4.
medtechdive.com
medtechdive.com/news/atricure-treatment-for-persistent-afib-shows-superiority-in-study/577643/AtriCure treatment for persistent AFib shows superiority in ...
The 67.7% success rate demonstrated at one year with the AtriCure device in the 153-patient trial exceeded the 50% effectiveness rate of ...
Efficacy and safety of hybrid epicardial and endocardial ...
We hypothesized hybrid epicardial-endocardial ablation (HA) would have superior effectiveness compared to CA, including repeat (rCA), in PersAF/LSPAF.
summary of safety and effectiveness data (ssed)
The AtriCure Synergy Ablation System is intended to ablate cardiac tissue for the treatment of persistent atrial fibrillation (sustained beyond seven days, or ...
Summary of Safety and Clinical Performance (SSCP) ...
More safety data will be collected in AtriCure's ICE-AFIB and LeAAPs clinical trials, AtriCure's VCLIP post-market study, and investigator ...
Adverse events related to Atricure EPi-Sense Coagulation ...
The most common AE was pericardial effusion, reported in 20 (25.3%) reports, followed by stroke in 14 (17.7%) cases.
9.
atricure.com
atricure.com/healthcare-professionals/therapies/LAAM/atriclip-exclusion-system/atriclip-pro-v-deviceAtriClip PRO-V Device | LAA Exclusion System
Limits on Scan Duration: Whole body averaged SAR of 2-W/kg for 60 minutes of continuous RF exposure (i.e., per pulse sequence or back-to-back sequences/series ...
AtriCure | Atrial Fibrillation Treatment | Pain Management
AtriCure provides innovative atrial fibrillation (Afib) treatment solutions, including the AtriClip device for LAAM and other surgical ablation therapies.
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