Smart Pass Feature for S-ICD Performance

Overseen By Kavin Panneerselvam

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Hemodynamic instability, Orthopedic issues, Cognitive impairment

Compensation: Varies

Number of Visits: 1

Duration: 1 visit

71 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates how well the Smart Pass feature detects muscle movements in individuals with an S-ICD, a heart device placed under the skin. The goal is to determine if Smart Pass can distinguish between normal muscle activity and irregular heart signals during simple arm exercises. Participants will perform exercises with the Smart Pass feature both activated and deactivated to compare results. This trial suits those with a specific S-ICD model who can perform basic exercises without orthopedic issues. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve device functionality and patient care.

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 seems unlikely since the study focuses on testing a feature of an implanted device during a routine check-up.

What prior data suggests that this feature is safe for use in S-ICD devices?

Research shows that the S-ICD device, a type of defibrillator placed under the skin, is quite safe. Studies indicate it has fewer issues with the device and its wires compared to other types. Specifically, only about 5.9% of people experienced device-related problems, and just 1.4% had issues with the wires.

The Smart Pass feature acts like a filter, reducing unnecessary shocks from the device. It can better distinguish between normal movements and irregular heart signals without increasing the risk of missing a real need for a shock.

Most people with the S-ICD device don't experience complications. In fact, 93.4% had no issues with the device itself, and 99.3% had no problems with the wire over the long term. This suggests the Smart Pass feature is well-tolerated and safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Smart Pass feature because it may enhance the performance of subcutaneous implantable cardioverter-defibrillators (S-ICDs) during exercise. Unlike traditional ICDs, which can sometimes misinterpret heart signals during physical activity, the Smart Pass filter aims to refine signal detection, potentially reducing false alarms and unnecessary shocks. This advancement could improve patient comfort and confidence during exercise, offering a more tailored approach to managing heart rhythm issues.

What evidence suggests that the Smart Pass feature is effective for differentiating muscle movement from irregular heart signals?

Research has shown that the Smart Pass feature in under-the-skin heart devices (S-ICDs) reduces unnecessary shocks. One study found that the Smart Pass filter prevented 97.6% of these unnecessary shocks over a year. Another study noted that advanced programming like Smart Pass improved device performance. In this trial, participants will be assigned to different groups where the Smart Pass filter will be either ON or OFF during exercise testing. These findings suggest that the Smart Pass feature effectively distinguishes between normal body movements and irregular heart signals, potentially enhancing the patient experience with fewer false alarms. ^{5 6 7 8 9}

Who Is on the Research Team?

Michael R Gold, MD, PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for adults over 18 with an EMBLEM S-ICD (specific models A209 or A219) from Boston Scientific. It's not suitable for those who are hemodynamically unstable, unable to do simple arm exercises due to orthopedic or cognitive issues.

Inclusion Criteria

Implanted EMBLEM S-ICD (Model A 209 and Model A 219, Boston Scientific, St Paul, MN, USA)

Exclusion Criteria

I am under 18 years old.

My blood pressure and heart rate are not stable.

I cannot do certain physical tests due to joint problems or thinking issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants perform arm exercises while the Smart Pass filter is turned on or off, and device data is collected.

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Smart Pass

Trial Overview The study tests a feature in the S-ICD device that distinguishes muscle movements from heart signals during arm exercises. Participants will have this 'Smart Pass' feature turned on and off in random order during one clinic visit.

How Is the Trial Designed?

Group I: Smart Pass ON Active Control 1 Intervention

Smart Pass filter will be programmed ON in the S-ICD while performing exercise testing.

Group II: Smart Pass OFF Placebo Group 1 Intervention

Smart Pass filter will be programmed OFF in the S-ICD while performing exercise testing.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Boston Scientific Corporation

Industry Sponsor

Trials

758

Recruited

867,000+

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

Yuji Ishida, MD

Collaborator

Trials

1

Recruited

70+

Published Research Related to This Trial

In a study of 75 patients with various coronary conditions, the S-ICD sensing algorithm showed significantly lower screening success rates in patients with STEMI (5%) compared to those with NSTE-ACS (56.7%) and CCS (81%), indicating potential challenges in its performance during acute ischemic events.

After revascularization, the screening success rate for STEMI patients improved dramatically from 5% to 81%, suggesting that timely intervention may enhance the S-ICD's effectiveness, but STEMI remained a strong predictor of initial screening failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential impact of acute coronary syndromes on automatic sensing system in Subcutaneous-ICDs. Narducci, ML., Scacciavillani, R., Pinnacchio, G., et al.[2022]

In a study of 348 patients with subcutaneous internal cardiac defibrillators (S-ICD), deactivation of the SMART Pass™ algorithm was found to significantly increase the risk of inappropriate therapy (IT), with a hazard ratio of 5.36, indicating a strong association between SP deactivation and IT events.

Corrective interventions, such as reprogramming the device or changing the sensing vector, successfully prevented further IT in 59% of cases, suggesting that proactive management of SP deactivation can effectively reduce the risk of inappropriate shocks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploiting SMART pass filter deactivation detection to minimize inappropriate subcutaneous implantable cardioverter defibrillator therapies: a real-world single-centre experience and management guide. Monkhouse, C., Wharmby, A., Carter, Z., et al.[2023]

In a study of 507 patients in Latin America, those receiving implantable cardioverter-defibrillators (ICDs) for primary prevention were generally older and had lower left ventricular ejection fractions (LVEF) compared to those receiving ICDs for secondary prevention.

Despite differences in patient characteristics, the rates of mortality and hospitalizations were similar between primary and secondary prevention groups, although secondary prevention patients experienced a higher rate of appropriate ICD therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Primary and secondary prevention of sudden cardiac death in the ICD Registry-Latin America]. Ramos, JL., Muratore, C., Pachón Mateos, JC., et al.[2018]

The study of 146 subcutaneous ICD patients showed that the second-generation device (Emblem-S-ICD) significantly reduced the incidence of T-wave oversensing (TWOS) and inappropriate shocks (IS) compared to the first-generation device (SQ1010), with rates of 4.2% versus 15.4%, respectively.

A software update (SMR8) for the SQ1010 device also indicated a trend towards reduced TWOS/IS, with rates dropping from 13.4% to 4.6% after the update, suggesting that both device advancements and software improvements can enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device updates successfully reduce T‑wave oversensing and inappropriate shocks in subcutaneous ICD patients. Larbig, R., Motloch, LJ., Bettin, M., et al.[2020]

The study involved 1116 patients with a left ventricular ejection fraction (LVEF) of 35% or less, and the subcutaneous implantable cardioverter-defibrillator (S-ICD) was successfully implanted in 99.6% of cases, demonstrating high procedural success rates.

The S-ICD showed a 30-day complication-free rate of 95.8%, indicating low perioperative risks, and it effectively converted induced ventricular fibrillation in 99.2% of patients during defibrillation testing, even in a higher-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding Outcomes with the EMBLEM S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED): Clinical characteristics and perioperative results. Boersma, LV., El-Chami, MF., Bongiorni, MG., et al.[2020]

Citations

1. academic.oup.com academic.oup.com/europace/article/25/5/euad040/7084165

Exploiting SMART pass filter deactivation detection to ... The SMART Pass™ (SP) algorithm is a high-pass filter that aims to reduce inappropriate therapy (IT) in subcutaneous internal cardiac ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/pace.15049

Device programing and SMART pass algorithm activation ... The S-ICD's performance has seen improvement over the years, owing to advancements in device programing strategies and to the progression of its ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.120.048728

Primary Results From the Understanding Outcomes With ... Patients were followed for 18 months. The primary end point was the IAS-free rate compared with a 91.6% performance goal, derived from the ...

4. news.bostonscientific.com news.bostonscientific.com/2020-05-08-Late-Breaking-Clinical-Trial-Data-Underscore-Safety-And-Efficacy-Of-Boston-Scientific-S-ICD-System

Late-Breaking Clinical Trial Data Underscore Safety And ... Data also demonstrated a 97.6% inappropriate shock-free rate at one year for patients who had the SMART Pass sensing filter – an advanced ...

5. jacc.org jacc.org/doi/10.1016/j.jacc.2023.05.037

Long-Term Safety and Efficacy of the Subcutaneous ... Complication-free rates were observed in 93.4% for the S-ICD device and 99.3% for the S-ICD lead, rates that exceeded the 85% performance goals.

6. bostonscientific.com bostonscientific.com/content/dam/bostonscientific/Rhythm%20Management/portfolio-group/EMBLEM_S-ICD/PDF/S-ICD_Clinical_Report_9.pdf

S-ICD: CONFIRMING SAFETY AND EFFICACY S-ICD is non-inferior to TV-ICD, with fewer device-related complications (5.9% vs 9.8%), and fewer lead-related complications (1.4% vs 6.6%).

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1547527124032351

Defibrillators SMART Pass automatic deactivation of ... SMART Pass, a high-pass filter, reduces inappropriate shocks by S-ICDs due to oversensing, without affecting the appropriate shock rate.2. Conclusion. Automatic ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10227655/

Exploiting SMART pass filter deactivation detection to ... The SMART Pass™ (SP) algorithm is a high-pass filter that aims to reduce inappropriate therapy (IT) in subcutaneous internal cardiac ...

9. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(18)30477-6/fulltext

Prospective blinded evaluation of a novel sensing ... Figure 1 Signal processing in the EMBLEM S-ICD using SMART Pass technology. The ECG is sent through the high-pass filter and through several ...