CalmiGo Device for Cardiovascular Disease

(CalmiGo Trial)

Overseen By Diana Albers

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Bipolar, Psychosis, Substance abuse, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a stress management device called CalmiGo to determine its impact on heart health after a heart attack or certain heart procedures. Participants will use the device alongside their standard heart care for 12 weeks, while others will continue with only their regular care. The researchers aim to discover if the device improves heart function. This trial may suit individuals who have recently experienced a heart attack or undergone procedures like stenting or valve replacement and are beginning cardiac rehab. As an unphased trial, it offers a unique opportunity to explore innovative methods to enhance heart recovery and overall well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the CalmiGo device is safe for cardiovascular disease patients?

Research has shown that the CalmiGo stress management device is easy to use. This wearable device is designed to be safe and effective without interrupting daily life. It provides relief from stress and anxiety without requiring surgery or medication. Studies have found that it significantly reduces anxiety, PTSD (post-traumatic stress disorder), stress, worry, and burnout. These findings suggest that the CalmiGo device is generally safe and typically does not cause harmful side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for cardiovascular disease, which often involve medications and lifestyle modifications, the CalmiGO device focuses on stress management to support cardiac rehabilitation. Researchers are excited about this device because it offers a non-invasive, user-friendly tool that patients can use daily to help manage stress, a key factor in heart health. By integrating this device into standard care, there's potential to enhance overall treatment outcomes, making recovery more holistic and potentially more effective.

What evidence suggests that the CalmiGo device is effective for cardiovascular disease?

Research has shown that the CalmiGo stress management device can significantly reduce anxiety, PTSD, stress, worry, and burnout. These benefits are crucial because stress can harm heart health. In this trial, one group of participants will use the CalmiGo device alongside standard care to determine if it can also enhance blood vessel function, which is vital for a healthy heart. Improved blood vessel function might lower the risk of heart disease. Early results suggest that using the device could enhance blood vessel function, making it a promising addition to regular heart care. ^{1 2 6 7 8}

Who Is on the Research Team?

Amir Lerman, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults who've had a recent heart attack and are starting cardiac rehab. They must be able to use the CalmiGo stress management device for 12 weeks and complete various health tests. It's not open to pregnant individuals, those with certain mental health conditions, unstable heart or lung disease, seizures, cognitive impairments, substance abuse history, or past suicidality.

Inclusion Criteria

I can use the CamliGo device for 12 weeks.

I recently had a heart attack and will be starting cardiac rehab.

Willingness to complete study questionnaires, blood tests, & EndoPat testing at the beginning and end of study

Exclusion Criteria

I have a history of seizures.

You have a history of using drugs or being dependent on them.

Pregnant Patient

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Testing

Baseline testing including EndoPAT testing, mental stress testing, blood tests for cardiovascular disease biomarkers, physical assessments, and survey questionnaires

1 week

Treatment

Participants undergo 12 weeks of cardiac rehabilitation with or without the CalmiGO stress management device

12 weeks

Weekly visits for rehabilitation

Reassessment

Reassessment of baseline tests including EndoPAT testing, mental stress testing, and blood tests

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CalmioGO Stress management device

Trial Overview The study is testing if using the CalmiGo stress management device along with standard care over 12 weeks improves blood vessel function compared to just standard care. Participants will be randomly assigned to either receive the device or not.

How Is the Trial Designed?

Group I: CalmioGo + Standard of care Experimental Treatment 1 Intervention

Use of CalmiGO stress management device once daily + standard of care during the 12 weeks of Cardiac rehabilitation

Group II: Standard of Care Active Control 1 Intervention

Stand of care alone with 12 weeks of Cardiac rehabilitation

CalmioGO Stress management device is already approved in United States, European Union for the following indications:

Approved in United States as CalmiGo for:

• Anxiety relief
• Stress management
• Panic attacks

Approved in European Union as CalmiGo for:

• Anxiety relief
• Stress management
• Panic attacks

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

CalmiGO

Collaborator

Trials

1

Recruited

100+

Published Research Related to This Trial

The meta-analysis of transcatheter aortic valve implantation (TAVI) devices showed that the ACURATE neo valve resulted in significantly fewer cases of new permanent pacemaker implantation compared to both the SAPIEN 3 and EVOLUT R/PRO valves, indicating a potential safety advantage.

Conversely, the SAPIEN 3 valve was associated with a significantly lower occurrence of moderate to severe paravalvular leak compared to the ACURATE neo valve, suggesting it may provide better efficacy in preventing this complication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the new generation transcatheter aortic valve in the real life studies. Review and meta-analysis. Acconcia, MC., Caretta, Q., Monzo, L., et al.[2020]

In a study of 39 patients aged around 80 years undergoing transcatheter aortic valve implantation (TAVI) with the Navitor device, all patients experienced successful device and procedural outcomes, indicating high efficacy of this third-generation technology.

At one-month follow-up, there were no cases of moderate or severe aortic regurgitation, and only one patient required a permanent pacemaker, suggesting a favorable safety profile for the Navitor device in treating severe aortic stenosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter aortic valve implantation with the novel-generation Navitor device: Procedural and early outcomes. Corcione, N., Berni, A., Ferraro, P., et al.[2022]

Transcatheter aortic valve implantation (TAVI) has become a safe and effective alternative to traditional surgical aortic valve replacement for severe aortic stenosis, suitable for patients regardless of their predicted surgical risk.

The review focuses on various commercially available TAVI devices and provides guidance on selecting the appropriate prosthesis based on individual patient anatomy and clinical factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prosthesis Tailoring for Patients Undergoing Transcatheter Aortic Valve Implantation. Leone, PP., Scotti, A., Ho, EC., et al.[2023]

Transcatheter aortic valve implantation (TAVI) is a key treatment for patients with severe aortic stenosis, but it carries a risk of cerebrovascular events, including silent embolic cerebral infarcts that may lead to cognitive decline.

Embolic protection devices like Embrella and Claret can reduce the volume of cerebral lesions detected by MRI, but their effectiveness in preventing clinical events such as stroke or cognitive decline remains unproven and needs further investigation in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Embolic Protection Devices During TAVI: Current Evidence and Uncertainties. Abdul-Jawad Altisent, O., Puri, R., Rodés-Cabau, J.[2017]

Transcatheter aortic valve implantation (TAVI) is a well-established treatment for patients who cannot undergo traditional surgery, but first-generation devices have issues like valve malpositioning and vascular complications.

Second-generation TAVI devices are being developed to address these problems and are either CE marked or in the process of evaluation, indicating advancements in safety and efficacy for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New-generation TAVI devices: description and specifications. Tchetche, D., Van Mieghem, NM.[2020]

Citations

1. withpower.com withpower.com/trial/phase-infarction-8-2021-e187c

CalmiGo Device for Cardiovascular Disease Trial Overview The study is testing if using the CalmiGo stress management device along with standard care over 12 weeks improves blood vessel function compared ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04521699/examination-of-the-impact-of-calmigos-stress-management-device-on-vascular-heath-and-cardiovascular-disease-risk

Examination of the Impact of CalmiGo's Stress ... The primary purpose of this study is to determine if there are significant differences with respect to baseline between those randomized to ...

3. calmigo.com calmigo.com/pages/clinical-studies?srsltid=AfmBOooU2R0dwvI9dLEEUnWtuFnaswHoeiv6aOgzChF9o_NPkkZsVdt3

Clinical studies CalmIGo's efficacy has been validated in a number of independent trials that showed a significant reduction in anxiety, PTSD, stress, worry, and burnout ...

4. clinconnect.io clinconnect.io/trials/NCT04521699

Examination of the Impact of CalmiGo's Stress Management This clinical trial is studying the effects of a stress management device called CalmiGo on heart health, specifically looking at how it may improve blood ...

5. app.trialscreen.org app.trialscreen.org/trials/myocardial-infarction-examination-impact-calmigo-s-stress-management-device-trial-nct04521699

Examining the Impact of CalmiGo's Stress Management ... Participants may benefit from improved vascular function and reduced cardiovascular disease risk if the CalmiGo device is effective. They will also receive ...

6. calmigo.com calmigo.com/pages/clinical-studies?srsltid=AfmBOopK_DfbubOfjhq9CK4dHnLM22SOKbxb7wWyMQbuz1gLmq_MevVp

Clinical studies CalmIGo's efficacy has been validated in a number of independent trials that showed a significant reduction in anxiety, PTSD, stress, worry, and burnout ...

7. seed.nih.gov seed.nih.gov/sites/default/files/2024-07/Device-Reimbursement-Case-Study-3.pdf

Device Reimbursement Case Study #3 General Wellness ... As a wearable device, it is designed to be minimally disruptive while providing safe, effective, non-invasive, and non-pharmacologic relief. • The system has ...

8. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06614634

NCT06614634 No information is available for this page.