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

Trial Summary

What is the purpose of this trial?

This study is enrolling participants who are already implanted with a S-ICD device ( subcutaneous ICD), and are undergoing a routine outpatient clinic follow up appointment to have their S-ICD checked. The aim of the study is to see if a feature in the device can recognize muscle movement and differentiate movement from irregular heart signals. The study involves doing some simple arm exercises while collecting device data, both with this feature turn on and then with it turned off. Participants will be randomized to either have the feature turned on or off initially then it will be programmed the alternative way and the same exercise testing will be repeated. The study will involve just one visit.

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 data supports the effectiveness of the Smart Pass treatment for S-ICD performance?

Research suggests that the Smart Pass algorithm, which is a filter used in subcutaneous implantable cardioverter-defibrillators (S-ICDs), can help reduce inappropriate therapies (unnecessary treatments) by minimizing false alarms. This is supported by findings that device updates, including Smart Pass, have successfully reduced issues like T-wave oversensing, which can lead to inappropriate shocks in patients. ^{1 2 3 4 5}

Research Team

Michael R Gold, MD, PhD

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

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

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

References

1. United States 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. [2020]

2. Ireland pubmed.ncbi.nlm.nih.gov

The potential impact of acute coronary syndromes on automatic sensing system in Subcutaneous-ICDs. [2022]

3. Mexico pubmed.ncbi.nlm.nih.gov

[Primary and secondary prevention of sudden cardiac death in the ICD Registry-Latin America]. [2018]

4. England 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. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Device updates successfully reduce T‑wave oversensing and inappropriate shocks in subcutaneous ICD patients. [2020]