Initial Management of Patients Receiving a Single Shock (IMPRESS)

(IMPRESS Trial)

Overseen By Cheryl Rutherford, RN, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sanjaya Gupta

Disqualifiers: Polymorphic VT/VF, Heart failure, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

Duration: 12 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best treatment for patients who have received a single shock from their heart device (ICD). It uses a special vest and a procedure to see if their heart can be made to beat too fast. If it can, doctors will decide whether medication or a corrective procedure is better. The goal is to reduce future shocks and hospital visits. The ICD has evolved to overcome the limitations of earlier devices and is now implanted similarly to cardiac pacemakers.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It seems like the focus is on testing new treatments, so you might be able to continue your current meds, but it's best to check with the trial organizers.

Is Non-Invasive Programmed Stimulation (NIPS) generally safe for humans?

Non-Invasive Programmed Stimulation (NIPS) is generally considered safe and is used as an alternative to more invasive procedures for assessing heart rhythm issues. It is often used in patients with implantable cardioverter defibrillators (ICDs) to reduce the need for invasive testing, and no significant safety concerns have been reported in the studies. ^{1 2 3 4 5}

How does the Non-Invasive Programmed Stimulation (NIPS) treatment differ from other treatments for ventricular tachycardia?

Non-Invasive Programmed Stimulation (NIPS) is unique because it allows doctors to assess the risk of ventricular tachycardia recurrence without needing invasive procedures. It uses implantable cardioverter-defibrillator (ICD) leads to perform tests, making it a safer and less invasive alternative to traditional methods. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Non-Invasive Programmed Stimulation (NIPS), Standard Medical Therapy, Ventricular Tachycardia Ablation?

Research shows that catheter ablation for ventricular tachycardia (a fast heart rhythm problem) can reduce the recurrence of this condition in patients with implantable cardioverter-defibrillators (ICDs), which are devices that help control irregular heartbeats. ^{6 7 8 9 10}

Who Is on the Research Team?

Sanjaya Gupta, MD

Principal Investigator

Saint Luke's Health System

Are You a Good Fit for This Trial?

Inclusion Criteria

Single or dual chamber ICD or BiVentricular ICD in situ

Ischemic or non-ischemic cardiomyopathy

Receive a single shock from their ICD for monomorphic ventricular tachycardia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Procedure

Participants undergo Non-Invasive Programmed Stimulation (NIPS) to assess the risk of ventricular tachycardia

1 day

1 visit (in-person)

Treatment

Participants are randomized to either antiarrhythmic medication therapy or ventricular tachycardia ablation based on NIPS results

12 months

Regular follow-up visits as per standard care

Follow-up

Participants are monitored for recurrent ICD shocks, hospitalizations, and other outcomes

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Non-Invasive Programmed Stimulation (NIPS)
• Standard Medical Therapy
• Ventricular Tachycardia Ablation

How Is the Trial Designed?

Group I: Ventricular Tachycardia Ablation Experimental Treatment 2 Interventions

Patients who have a positive NIPS study and are randomized to the ablation arm will undergo ventricular tachycardia ablation procedure guided by CardioInsight.

Group II: Negative NIPS/Non-intervention Experimental Treatment 1 Intervention

Patients who had a negative NIPS study will not be assigned to a treatment group and will be followed according to standard of care.

Group III: Standard medical therapy Active Control 2 Interventions

Patients who have a positive NIPS study and are randomized to the medical therapy arm will either be initiated on antiarrhythmic therapy or will have their antiarrhythmic therapy intensified. All medication therapy is considered usual standard therapy.

Who Is Running the Clinical Trial?

Sanjaya Gupta

Lead Sponsor

Trials

3

Recruited

560+

Saint Luke's Health System

Lead Sponsor

Trials

42

Recruited

12,600+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Published Research Related to This Trial

In a study of 34 patients with metastatic melanoma treated with dabrafenib and trametinib, high plasma concentrations of dabrafenib showed only a weak association with progression-free survival, indicating that monitoring these levels may not effectively predict treatment response.

No significant relationship was found between plasma concentrations of dabrafenib and trametinib and the occurrence of common adverse events, suggesting that these measurements may not be useful for assessing safety in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring of plasma concentrations of dabrafenib and trametinib in advanced BRAFV600mut melanoma patients. Raynal, M., Alvarez, JC., Saiag, P., et al.[2022]

Citations

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

Preventive or Deferred Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy and Implantable Defibrillator (BERLIN VT): A Multicenter Randomized Trial. [2021]

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

ICD replacement in patients with intermediate left ventricular dysfunction under optimal medical treatment. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Time to next treatment or death as a candidate surrogate endpoint for overall survival in advanced melanoma patients treated with immune checkpoint inhibitors: an insight from the phase III CheckMate 067 trial. [2022]

4. France pubmed.ncbi.nlm.nih.gov

Monitoring of plasma concentrations of dabrafenib and trametinib in advanced BRAFV600mut melanoma patients. [2022]

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

Treatment-Free Survival After Nivolumab vs Pembrolizumab vs Nivolumab-Ipilimumab for Advanced Melanoma. [2023]

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

Long-term outcome and mode of recurrence following noninducibility during noninvasive programmed stimulation after ventricular tachycardia ablation. [2019]

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

Noninvasive programmed ventricular stimulation early after ventricular tachycardia ablation to predict risk of late recurrence. [2014]

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

Effectiveness of noninvasive programmed stimulation for initiating ventricular tachyarrhythmias in patients with third-generation implantable cardioverter defibrillators. [2019]

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

Noninvasive Programmed Ventricular Stimulation-Guided Management Following Ventricular Tachycardia Ablation. [2020]

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

Noninvasive programmed stimulation in the setting of ventricular tachycardia catheter ablation. [2021]