New treatment option for Ventricular Tachycardia (VT)
Official title Non-Invasive Programmed Stimulation (NIPS) to Guide the Subsequent VT Therapeutic Strategies
ClinicalTrials.gov ID: NCT06669299
What this study is testing
What is Antiarrhythmic Drug Therapy (amiodarone, sotalol, or mexiletine)?
Antiarrhythmic Drug Therapy (amiodarone, sotalol, or mexiletine) is an investigational medicine, being studied as a potential treatment for ventricular tachycardia (vt).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The aim of this study is to define the importance of non-invasive programmed stimulation (NIPS) in risk stratification of ventricular tachycardia (VT) recurrence after catheter ablation and to determine the optimal treatment strategy. The primary objective is to establish whether a new VT ablation based on NIPS inducibility will reduce the risk of VT recurrence compared to antiarrhythmic drug therapy.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with an implanted ICD (all brands)
- Patients who underwent a successful (non-inducibility of any VT) Ventricular Tachycardia Ablation procedure, the "index procedure", supported by...
- Induction of monomorphic VT at NIPS 3-7days after a successful index procedure
- Age 18 years or more
- Able to provide an informed consent to participate to the study and available to respect the assessments described in the protocol.
You likely can't join if
- Inducible VT after index procedure
- Contraindication to anticoagulants
- Presence of thrombi
- Presence of Mitral and Aortic prosthetic valve
- Recent (\<3 months) myocardial infarction or unstable angina or Coronary Artery Bypass
- Pregnant or nursing
See the full eligibility criteria
- Patients with an implanted ICD (all brands)
- Patients who underwent a successful (non-inducibility of any VT) Ventricular Tachycardia Ablation procedure, the "index procedure", supported by EnSite Precision or CARTO 3D mapping systems for the following etiologies...
- Induction of monomorphic VT at NIPS 3-7days after a successful index procedure
- Age 18 years or more
- Able to provide an informed consent to participate to the study and available to respect the assessments described in the protocol.
- Inducible VT after index procedure
- Contraindication to anticoagulants
- Presence of thrombi
- Presence of Mitral and Aortic prosthetic valve
- Recent (\<3 months) myocardial infarction or unstable angina or Coronary Artery Bypass
- Pregnant or nursing
- Ventricular Tachycardia caused by reversible pathology
- \< 1 Year life expectancy according to the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Milan, Italy, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milan, Italy, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.