Therapies for Ventricular Tachycardia

(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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best treatment for individuals who receive a single shock from an implantable cardioverter defibrillator (ICD), a device that helps control heart rhythm. Participants will wear a special electrode vest to detect the origin of heart rhythm issues and will undergo Non-Invasive Programmed Stimulation (NIPS) to test their heart’s response to stimulation. Based on the results, they may receive standard medication, undergo catheter ablation (ventricular tachycardia ablation), or continue with regular care. The trial seeks to determine which treatment approach—watchful waiting, medication, or ablation—proves most effective. Individuals with an ICD who have received a shock for ventricular tachycardia (a type of fast heart rhythm) might be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance treatment options for future patients.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ventricular tachycardia ablation is generally safe, though it carries some risks. In a large study, 8.5% of patients experienced unwanted side effects, and 3% had major side effects. Additionally, 1.7% of patients died within 30 days after the procedure. Another study found that 18% of patients had died 12 months after the procedure. These findings indicate that while many undergo the procedure without issues, potential risks exist.

Those considering this treatment should discuss these possible outcomes with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the IMPRESS trial because it aims to discover the best initial management for patients who experience a single shock from a defibrillator. Unlike traditional methods that primarily rely on standard medical therapy with antiarrhythmic drugs, this trial explores the potential of Non-Invasive Programmed Stimulation (NIPS) and Ventricular Tachycardia Ablation. NIPS offers a non-invasive way to assess the heart's electrical system, potentially leading to more personalized treatment plans. In contrast, Ventricular Tachycardia Ablation directly targets and eliminates areas in the heart responsible for abnormal rhythms using advanced mapping techniques. This trial could reshape how we approach treatment for ventricular tachycardia by identifying which methods provide the most effective outcomes with fewer side effects.

What evidence suggests that this trial's treatments could be effective for patients with heart rhythm abnormalities?

Research shows that catheter ablation, studied in this trial as part of the Ventricular Tachycardia Ablation arm, can effectively treat ventricular tachycardia, a type of fast heart rhythm. One study found the procedure successful for 88.3% of patients with non-ischemic heart disease and 79.3% of those with ischemic heart disease. However, the condition can return, with recurrence rates between 37% and 58% within a year, depending on the procedure specifics. Additionally, there is a 6.8% chance of patients passing away in the hospital within a year and a 16.9% chance of needing readmission due to recurring issues. Overall, catheter ablation can significantly help manage ventricular tachycardia, but it carries some risks. ^{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. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.034814

Ten‐Year Outcomes and Predictors of Mortality Following ... Estimated 10‐year all‐cause mortality following hospital discharge after catheter ablation of ventricular tachycardia was 39.4% in an all‐comer ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0972629225000932

Long-term outcomes of ventricular tachycardia ablation in ... Complete procedure success was higher in patients from the NICMP group (88.3 % in NICMP compared to 79.3 % in ICMP). VT recurrence occurred in ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40086656

Mortality and readmissions after ventricular tachycardia ... The 1-year in-hospital mortality rate, all-cause readmission rate, and recurrent VT readmission rate were 6.8%, 43.4%, and 16.9%, respectively, and were broadly ...

4. heartrhythmopen.com heartrhythmopen.com/article/S2666-5018(24)00373-8/fulltext

Clinical outcomes after ventricular tachycardia ablation ... VT induction was attempted in 63% of patients. The 1-year incidence of recurrent VT was 37% and 58% in the noninduction and induction groups, ...

5. jacc.org jacc.org/doi/10.1016/j.jacep.2022.10.024

Causes of Early Mortality After Ventricular Tachycardia ... The overall early mortality (≤30 days) rate after catheter ablation of VT in patients with reduced LVEF was 5.0%, but the death rate directly due to a ...

6. jacc.org jacc.org/doi/10.1016/j.jacep.2020.07.028

Safety and Outcomes of Ventricular Tachycardia Substrate ... Outcomes: early and late mortality. Thirty-day mortality after the first VT ablation procedure was 1.7% (n = 7). Of these, 3 patients died ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9893573/

Safety of Ventricular Tachycardia Ablation in Clinical Practice Of 9699 hospitalizations with VT ablations (age 56.5±17.6; 60.1% male), AEs were reported in 825 (8.5%), MAEs in 295 (3.0%) and death in 110 ( ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2666501824003738

Clinical outcomes after ventricular tachycardia ablation ... Short-term safety outcomes included immediate postprocedural complications, AKI, transfer to the cardiac intensive care unit (CCU), time to discharge, death or ...

9. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(23)00755-5/fulltext

MP-453083-11 SAFETY AND OUTCOMES OF ... In this large, real-world database study, we found no significant differences in procedure related complications or hospital length of stay across all age ...

10. ahajournals.org ahajournals.org/doi/10.1161/JAHA.117.007045

Ablation Outcomes and Predictors of Mortality Following ... The 12‐month mortality rate in the Multicenter Thermocool Ventricular Tachycardia Ablation Trial was 18%. Interestingly, the mortality rate in ...