Surgical Ablation for Rapid Heartbeat

Recruiting in Palo Alto (17 mi)

+25 other locations

Overseen by Thomas Beaver, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: AtriCure, Inc.

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new procedure that treats fast heartbeats without damaging the heart's natural pacemaker. It is aimed at patients with Inappropriate Sinus Tachycardia (IST) who do not respond to or cannot tolerate medications. The procedure works by carefully modifying parts of the heart to correct the abnormal rhythm.

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 data supports the effectiveness of the AtriCure ISOLATOR Synergy Surgical Ablation System treatment 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 heartbeat) by creating precise lesions in heart tissue. This technology has been evaluated in both acute and chronic studies, demonstrating its ability to isolate critical areas of the heart to prevent irregular heartbeats. ^{1 2 3 4 5}

Is surgical ablation for rapid heartbeat generally safe for humans?

The available research does not provide specific safety data for surgical ablation for rapid heartbeat or the AtriCure ISOLATOR Synergy Surgical Ablation System. However, it highlights the importance of standardized reporting of adverse events during surgery to better understand safety outcomes. ^{6 7 8 9 10}

How does the AtriCure ISOLATOR Synergy Surgical Ablation System treatment differ from other treatments for rapid heartbeat?

The AtriCure ISOLATOR Synergy Surgical Ablation System is unique because it uses a novel dual-electrode bipolar radiofrequency device to create precise lesions in heart tissue, which helps isolate problematic areas causing rapid heartbeat. This method is less invasive than traditional surgical procedures and can be performed more quickly and safely, reducing the risk of damage to surrounding heart structures. ^{1 2 3 11 12}

Research Team

Dhanunjaya Lakkireddy

Principal Investigator

Kansas City Heart Rhythm Institute

Thomas Beaver, MD

Principal Investigator

University of Florida

Carlo de Asmundis, MD

Principal Investigator

Universitair Ziekenhuis Brussel

Mark La Meir, MD, PhD

Principal Investigator

Universitair Ziekenhuis Brussel

Eligibility Criteria

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 am between 18 and 75 years old.

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

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.

Trial Timeline

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

Treatment Details

Interventions

• AtriCure ISOLATOR Synergy Surgical Ablation System (Procedure)

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

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]

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]

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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of a Novel Bipolar Radiofrequency Clamp: An Acute Porcine Model. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Atricure bipolar radiofrequency clamp for intraoperative ablation of atrial fibrillation. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Performance of a novel dual-electrode bipolar radiofrequency ablation device: a chronic porcine study. [2012]

4. United States pubmed.ncbi.nlm.nih.gov

Chronic performance of a novel radiofrequency ablation device on the beating heart: Limitations of conduction delay to assess transmurality. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Where does atrial fibrillation surgery fail? Implications for increasing effectiveness of ablation. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Severity Grading Systems for Intraoperative Adverse Events. A Systematic Review of the Literature and Citation Analysis. [2023]

7. England pubmed.ncbi.nlm.nih.gov

A Protocol for the Development of the Intraoperative Complications Assessment and Reporting With Universal Standards Criteria: The ICARUS Project. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Adverse events associated with the intraoperative injection of isosulfan blue. [2014]

9. United States pubmed.ncbi.nlm.nih.gov

Complications associated with PEAK PlasmaBlade from 2010 to 2020 from MAUDE. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Recommendations for Intraoperative Adverse Events Data Collection in Clinical Studies and Study Protocols. An ICARUS Global Surgical Collaboration Study. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Surgical ablation of atrial fibrillation. [2005]

12. England pubmed.ncbi.nlm.nih.gov

Cardioblate surgical ablation system. [2009]