Surgical Ablation for Rapid Heartbeat

Recruiting at 24 trial locations

Overseen By John Doty, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AtriCure, Inc.

Disqualifiers: ICDs/Pacemakers, Channelopathies, Congenital heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate procedure

142 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new procedure for individuals with Inappropriate Sinus Tachycardia (IST), a condition that causes a very fast heartbeat and can disrupt daily life. The goal is to determine if a surgical technique called hybrid sinus node sparing ablation, using the AtriCure ISOLATOR Synergy Surgical Ablation System, can safely and effectively treat those whose IST does not improve with medication. Eligible participants include those with IST who have found medications like beta-blockers ineffective or intolerable. As an unphased trial, this study provides patients the opportunity to explore innovative treatment options that might not be available elsewhere.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have a history of drug intolerance or failure, which might imply that you should not be on effective medication for your condition.

What prior data suggests that this surgical ablation system is safe for treating inappropriate sinus tachycardia?

Research has shown that the AtriCure ISOLATOR Synergy Surgical Ablation System has been safely used for heart rhythm problems. The FDA approved this system for treating atrial fibrillation, another heart condition, indicating its general safety for people.

In past studies, patients using this system experienced few serious side effects. Most handled the procedure well, with common issues being minor and manageable, such as temporary discomfort at the procedure site.

Overall, the system has a strong safety record in similar heart treatments. This should reassure participants about its safety in new trials for treating inappropriate sinus tachycardia, a condition that causes a fast heartbeat. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The AtriCure ISOLATOR Synergy Surgical Ablation System is unique because it offers a hybrid sinus node sparing ablation procedure, which is different from the traditional ablation methods that may impact the sinus node, potentially leading to complications like the need for a pacemaker. What sets this treatment apart is its ability to specifically target and isolate the problematic heart tissue responsible for rapid heartbeat without affecting the sinus node, which is crucial for maintaining the heart's natural rhythm. Researchers are excited because this approach could lead to fewer side effects and more precise treatment for patients with rapid heartbeat conditions, improving overall outcomes and quality of life.

What evidence suggests that the AtriCure ISOLATOR Synergy Surgical Ablation System is effective for inappropriate sinus tachycardia?

Research has shown that the AtriCure ISOLATOR Synergy Surgical Ablation System effectively treats atrial fibrillation, a type of irregular heartbeat. In studies, about 77.1% of patients maintained a stable heart rhythm without needing additional medication or procedures one year after treatment. The device uses bipolar radiofrequency energy to target and modify specific heart tissue, helping to normalize heartbeats. While primarily used for atrial fibrillation, its mechanism suggests potential benefits for individuals with inappropriate sinus tachycardia (IST), a condition with limited treatment options. This trial will evaluate the system's effectiveness for IST through a hybrid sinus node sparing ablation procedure. ^{1 3 4 6 7}

Who Is on the Research Team?

Dhanunjaya Lakkireddy

Principal Investigator

Kansas City Heart Rhythm Institute

Thomas Beaver, MD

Principal Investigator

University of Florida

Mark La Meir, MD, PhD

Principal Investigator

Universitair Ziekenhuis Brussel

Carlo de Asmundis, MD

Principal Investigator

Universitair Ziekenhuis Brussel

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with Inappropriate Sinus Tachycardia (IST) who haven't responded to or can't tolerate certain heart rate control drugs. Participants must be able to consent and commit to follow-up visits. Exclusions include those with pacemakers, previous heart surgery, severe other conditions, drug abuse, BMI ≥ 35, or life expectancy under 2 years.

Inclusion Criteria

I have been diagnosed with IST.

I have a history of not responding well to certain heart medications.

Subject is willing and able to provide written informed consent

Exclusion Criteria

I have a condition like anemia or severe asthma that could cause a fast heart rate.

You are not expected to live more than 2 years.

You have a history of drug or alcohol abuse.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System

Immediate procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6-, 12-, and 24-months post-procedure

24 months

Multiple visits (in-person and virtual)

Long-term Monitoring

Participants' heart rate variability and other health metrics are monitored using 7-day continuous monitoring and implantable loop recorders

12 months

What Are the Treatments Tested in This Trial?

Interventions

• AtriCure ISOLATOR Synergy Surgical Ablation System

Trial Overview The HEAL-IST IDE Trial is testing the AtriCure ISOLATOR Synergy Surgical Ablation System's safety and effectiveness in treating symptomatic IST that doesn't improve with medication. The procedure aims to preserve the sinus node while addressing rapid heartbeat issues.

How Is the Trial Designed?

Group I: Hybrid sinus node sparing ablation procedure Experimental Treatment 1 Intervention

Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System

Who Is Running the Clinical Trial?

AtriCure, Inc.

Lead Sponsor

Trials

43

Recruited

22,800+

Published Research Related to This Trial

Intraoperative adverse events (iAEs) are often underreported in surgical literature, leading to a significant gap in understanding their impact on patient outcomes, which this study aims to address by developing the ICARUS Guidelines for standardized reporting.

The ICARUS Guidelines will be created through a consensus-based approach involving expert surgeons and will be disseminated widely to improve the consistency and quality of reporting iAEs across surgical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Protocol for the Development of the Intraoperative Complications Assessment and Reporting With Universal Standards Criteria: The ICARUS Project. Cacciamani, G., Sholklapper, T., Sotelo, R., et al.[2022]

The Maze procedure for surgical ablation of atrial fibrillation (AF) has a high success rate of over 90% in curing the arrhythmia, making it the most effective treatment option available.

Recent advancements in surgical techniques and technologies allow for safer and more efficient ablation procedures, including the ability to perform these surgeries through minimally invasive approaches, which can benefit patients with isolated AF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical ablation of atrial fibrillation. Gillinov, AM., Wolf, RK.[2005]

The Atricure Synergy device successfully created reliable and chronic transmural lesions in a porcine model of atrial fibrillation, demonstrating its safety and efficacy without the need for cardiopulmonary bypass.

All six pigs in the study survived the procedure, showed electrical isolation of key heart areas, and did not develop complications like thrombus formation, indicating the device's potential for effective treatment of atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of a novel dual-electrode bipolar radiofrequency ablation device: a chronic porcine study. Voeller, RK., Zierer, A., Schuessler, RB., et al.[2012]

The Cardioblate surgical ablation system utilizes saline-irrigated radiofrequency energy to create electrically isolating lines in atrial tissue, which is crucial for treating atrial fibrillation effectively.

This system provides a comprehensive approach to surgical ablation, showing promising results when compared to other energy sources and traditional methods like the Cox-Maze procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardioblate surgical ablation system. Wahba, A.[2009]

The study reviewed 2957 articles but found only 7 that proposed or validated intraoperative adverse event (iAE) severity grading systems, highlighting a significant gap in standardized assessment methods for surgical complications.

Despite the critical need for grading systems to improve patient safety, only 56.9% of clinical studies that cited these systems actually used them, indicating poor adoption and the necessity for a uniform grading system to enhance data comparability and reduce adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severity Grading Systems for Intraoperative Adverse Events. A Systematic Review of the Literature and Citation Analysis. Sayegh, AS., Eppler, M., Sholklapper, T., et al.[2023]

A review of 384 reports on the PEAK PlasmaBlade 3.0 and 4.0 revealed that 82.1% of adverse events were due to device malfunctions, with the most common issues being delaminated coating and ignition or fire.

While the device is useful in surgeries, it has been linked to patient and operator injuries, highlighting the need for better education on its risks and standardized reporting protocols to improve safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications associated with PEAK PlasmaBlade from 2010 to 2020 from MAUDE. Lee, E., Elzomor, A., Boulos, S., et al.[2022]

The EnCompass™ radiofrequency bipolar device successfully achieved complete transmural isolation of the left atrial posterior wall in all tested cases, indicating its effectiveness for surgical ablation in atrial fibrillation treatment.

Compared to a reference device, the EnCompass™ clamp produced lesions that were 1.5 times wider and delivered 5 times more energy, suggesting it may simplify the surgical ablation process and enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Novel Bipolar Radiofrequency Clamp: An Acute Porcine Model. Yates, TA., McGilvray, M., Razo, N., et al.[2022]

In a study of 1835 patients undergoing various surgical procedures, adverse events from the intraoperative injection of isosulfan blue occurred in 1.5% of cases, with 0.75% classified as major events, including potentially life-threatening hypotension.

The most common adverse event was skin reactions, but significant risk factors for adverse events included injections in the vulvar area and chronic use of certain blood pressure medications, highlighting the need for anesthesiologists to be vigilant and prepared with antiallergy medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events associated with the intraoperative injection of isosulfan blue. Daley, MD., Norman, PH., Leak, JA., et al.[2014]

The ICARUS Global Surgical Collaboration has developed a comprehensive system for collecting data on intraoperative adverse events (iAEs), addressing the lack of standardized reporting in surgical literature.

This study provides essential tools, including core-set variables and guidelines for reporting iAEs, which are based on globally validated criteria, aiming to improve patient safety and outcomes in surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations for Intraoperative Adverse Events Data Collection in Clinical Studies and Study Protocols. An ICARUS Global Surgical Collaboration Study. Cacciamani, GE., Eppler, M., Sayegh, AS., et al.[2023]

The Atricure bipolar radiofrequency system was evaluated in 120 patients for the intraoperative treatment of atrial fibrillation (AF), demonstrating no device-related complications, which highlights its safety in clinical use.

The system effectively creates transmural lesions for pulmonary vein isolation, although careful application is crucial to avoid incomplete isolation due to tissue folding, which can be resolved with reapplication of the clamp.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atricure bipolar radiofrequency clamp for intraoperative ablation of atrial fibrillation. Gillinov, AM., McCarthy, PM.[2019]

The AtriCure Coolrail device, designed for epicardial ablation, was only able to create transmural lesions in 76% of cases, indicating inconsistent effectiveness in achieving complete tissue ablation.

Despite showing acute conduction delay immediately after ablation, the lesions did not maintain this effect after 4 weeks, suggesting that the device fails to provide reliable long-term results for atrial myocardium ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic performance of a novel radiofrequency ablation device on the beating heart: Limitations of conduction delay to assess transmurality. Lee, AM., Aziz, A., Clark, KL., et al.[2021]

The classic maze procedure showed the highest success rate for maintaining freedom from atrial fibrillation at 90%, while high-intensity focused ultrasound had a significantly lower success rate of only 43%, indicating that the choice of surgical technique greatly impacts outcomes.

In cases of atrial fibrillation recurrence, the right atrium was identified as a common source of failure, particularly in patients who underwent left atrial maze procedures or pulmonary vein isolation, suggesting that comprehensive mapping and targeted ablation strategies are crucial for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Where does atrial fibrillation surgery fail? Implications for increasing effectiveness of ablation. McCarthy, PM., Kruse, J., Shalli, S., et al.[2022]

Citations

1. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf10/P100046b.pdf

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 ...

2. atricure.com atricure.com/patients-caregivers/clinical-evidence/trials-results

Trials with Results | Atrial Fibrillation Treatment This page contains information about clinical trials that are sponsored by AtriCure, Inc. If you wish to learn more, please visit ClinicalTrials.gov.

3. withpower.com withpower.com/trial/phase-inappropriate-sinus-tachycardia-5-2022-4d790

Surgical Ablation for Rapid Heartbeat Research shows that the AtriCure Synergy device, which uses bipolar radiofrequency energy, is effective in treating atrial fibrillation (a type of irregular ...

4. europe.atricure.com europe.atricure.com/sites/default/files/devices-ifu/CEM-278.D%20Isolator%20Synergy%20Clamps%20SSCP_EN.pdf

Summary of Safety and Clinical Performance (SSCP) ... This prospective, open label, multi-center, observational, single arm registry was designed to monitor the AtriCure Synergy Ablation System.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0010865017300486

Middle-term results of hybrid atrial fibrillation ablation using ... Twelve months after the procedure, 77.1% of patients had a stable SR without any anti-arrhythmic medication or re-ablation. If we included those on anti- ...

6. ir.atricure.com ir.atricure.com/news-releases/news-release-details/atricure-announces-first-patient-treated-boxx-noaf-clinical

AtriCure Announces the First Patient Treated in the BoxX- ... “We expect results of these trials to demonstrate that use of AtriCure devices can safely and effectively improve outcomes for cardiac surgery ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01174745

NCT01174745 | ABLATE Post Approval Study - Synergy ... This single arm registry is designed to monitor the AtriCure Synergy Ablation System for continued safety and efficacy during the peri-procedural and long term ...