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

Trial Summary

What is the purpose of this trial?

The primary purpose of this study is to determine if there are significant differences with respect to baseline between those randomized to CGo and standard-of-care versus standard-of-care alone after completing 12-weeks of therapy in terms of peripheral endothelial function measured by EndoPAT.

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.

How is the CalmiGo device treatment for cardiovascular disease different from other treatments?

The CalmiGo device is unique because it focuses on stress management, which is not a standard approach for treating cardiovascular disease. Unlike traditional treatments that may involve medication or surgery, CalmiGo uses a non-invasive method to help manage stress, potentially benefiting heart health indirectly. ^{1 2 3 4 5}

Research Team

Amir Lerman, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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 am 18 years old or older.

I can use the CamliGo device for 12 weeks.

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

Exclusion Criteria

I have a history of seizures.

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

Pregnant Patient

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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]

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]

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 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]

References

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

Transcatheter aortic valve implantation with the novel-generation Navitor device: Procedural and early outcomes. [2022]

2. Spain pubmed.ncbi.nlm.nih.gov

Embolic Protection Devices During TAVI: Current Evidence and Uncertainties. [2017]

3. Italy pubmed.ncbi.nlm.nih.gov

Effectiveness of the new generation transcatheter aortic valve in the real life studies. Review and meta-analysis. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Prosthesis Tailoring for Patients Undergoing Transcatheter Aortic Valve Implantation. [2023]

5. France pubmed.ncbi.nlm.nih.gov

New-generation TAVI devices: description and specifications. [2020]