130 Participants Needed

Management for Ventricular Tachycardia

(MANAGE-VT Trial)

MC
EM
Overseen ByEdward M Burke
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: CorVita Science Foundation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on understanding ventricular tachycardia, a heart rhythm disorder, to help doctors enhance treatment plans. Researchers will collect data from patients to assess condition management and monitor EKG results. Individuals diagnosed with ventricular tachycardia who experience symptoms like irregular heartbeats may be suitable for this study. The goal is to gather information that can lead to improved care and treatment options. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to a potentially groundbreaking treatment.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

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

Previous research has studied the safety of ventricular tachycardia ablation. One study found that 1.7% of patients died within 30 days after the procedure. Another study reported overall complication and death rates of 7.1% and 3.7%, respectively. These studies indicate that while risks exist, the procedure is generally safe for most people. Although adverse outcomes have increased over time, this increase results from patients having more risk factors, not the procedure itself. Evidence suggests that many patients undergo the procedure without serious problems.12345

Why are researchers excited about this trial?

Researchers are excited about the MANAGE-VT trial because it aims to improve how we understand and manage ventricular tachycardia, a serious heart rhythm problem. Unlike traditional treatments like antiarrhythmic drugs or catheter ablation, this trial focuses on gathering comprehensive data about the condition, including EKG results and other health markers. By creating a detailed registry, the trial could help identify more personalized and effective treatment strategies, potentially leading to better patient outcomes and new approaches in managing ventricular tachycardia.

What evidence suggests that ventricular tachycardia ablation is effective for ventricular tachycardia?

This trial will assess the effectiveness of ventricular tachycardia ablation, a procedure that can reduce the chances of ventricular tachycardia (VT), a condition where the heart beats too fast. One study found that 69% of patients did not experience VT episodes one year after the procedure. Ablation stops the electrical signals that cause the heart to beat too quickly. Long-term research suggests that while it may not significantly extend life, it reduces repeated episodes of fast heartbeats, known as VT storms. Early results indicate that the procedure successfully controls symptoms and improves patients' quality of life.46789

Are You a Good Fit for This Trial?

Inclusion Criteria

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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Data Collection

Patient data including anticoagulant medications, VT history, EKGs, echocardiograms, VT ablations, ICDs, S-ICDs, lab results, and comorbidities are collected

Follow-up

Participants are monitored for recurrence of ventricular tachycardia, risk of sudden cardiac death, and risk of stroke

Ongoing since July 20, 2020

What Are the Treatments Tested in This Trial?

Interventions

  • ICD Implant
  • Ventricular Tachycardia Ablation

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: MANAGE-VT PatientsExperimental Treatment6 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

CorVita Science Foundation

Lead Sponsor

Trials
2
Recruited
1,100+

Citations

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 ...

Long-term Outcomes of Ventricular Tachycardia Ablation in ...

Although prior studies have not demonstrated long-term mortality benefit, ablation is effective in reducing long-term VT recurrences, abolishing VT storm and ...

Clinical outcomes after ventricular tachycardia ablation ...

Median follow-up after initial ablation was 16 months. Thirty-nine of 56 patients (70%) in the induction group had VT induced successfully. The prevalence of ...

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 ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/30236386/

Outcomes of Catheter Ablation of Ventricular Tachycardia ...

One-year freedom from VT was 69%, and freedom from VT, heart transplantation, and death was 62%. On unadjusted competing risk analysis, VT ablation in ARVC ...

Safety of Ventricular Tachycardia Ablation in Clinical Practice

Though adverse outcomes associated with VT ablation have increased over time, our data demonstrate concomitant increase in patient risk factors, ...

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 ...

Trends and Outcomes of Catheter Ablation of Ventricular ...

Overall procedural complication and mortality rates after VT ablation were 7.1% and 3.7%, respectively. There were no significant differences ...

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 ...