Prophylactic Substrate Ablation in Post-myocardial Patients Undergoing Defibrillator Implantation.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2020-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Prophylactic substrate ablation in post-MI patients undergoing defibrillator implantation reduces appropriate defibrillator therapies.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators

NCT01557842

Ventricular Tachycardia Ischemic

TERMINATED PHASE4

Preventive VT Substrate Ablation in Ischemic Heart Disease

NCT04675073

Ventricular Tachycardia Ventricular Arrythmia Sudden Cardiac Death +4 more

RECRUITING PHASE3

Substrate Modification in Stable Ventricular Tachycardia in Addition to Implantable Cardioverter Defibrillator (ICD) Therapy

NCT00919373

Ventricular Tachycardia Coronary Artery Disease Left Ventricular Dysfunction

COMPLETED NA

Late Potentials and Ablation Index in Ventricular Tachycardia Ablation

NCT03437408

Ventricular Tachycardia

COMPLETED NA

Cardiac Sympathetic Denervation for Prevention of Ventricular Tachyarrhythmias

NCT01013714

Sudden Cardiac Death Ventricular Tachycardia Ventricular Fibrillation +1 more

RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Background In patients with Ventricular Tachycardia (VT) and structural heart disease, the Implanted Cardioverter Defibrillator (ICD), provides a significant protection against the risk of sudden death, however it does not prevent arrhythmia recurrences \[1-7\]. ICD therapies, especially shocks, pose several risks, including decreased quality of life, increased mortality among patients who suffer ICD shock compared with patients who do not and clinically significant anxiety and depression as a result of recurrent ICD shocks, which has been found to occur in more than 50% of patients \[8-12\]. Furthermore, ICD implantation has been found not to protect against sudden cardiac death in 3-7% of patients \[13\].

The benefit of novel ICD programming in reducing inappropriate ICD therapy and mortality was demonstrated in Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT) \[14\]. Catheter ablation has been considered a plausible curative therapy for VT prevention, especially in patients with VT episodes \[15\]. The Substrate Mapping and Ablation in Sinus Rhythm to Halt Ventricular Tachycardia (SMASH-VT) and the Ventricular Tachycardia Ablation in Coronary Heart Disease (VTACH) found that prophylactic catheter ablation reduces the incidence of appropriate ICD therapy in patients who had undergone ICD implantation as a means of secondary prevention and had a history of myocardial infarction (MI) \[16,17\]. It was also shown in a small retrospective study that prophylactic catheter ablation for induced VT reduced the incidence of appropriate ICD therapy in primary prevention post-MI patients \[18\].

Aim of the study - Statement of Hypothesis Prophylactic substrate ablation in post-MI patients undergoing defibrillator implantation reduces appropriate defibrillator therapies.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure Myocardial Infarction Ventricular Tachycardia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prophylactic substrate ablation group

Prophylactic substrate ablation group will undergo substrate mapping and ventricular tachycardia substrate ablation

Group Type ACTIVE_COMPARATOR

Ventricular tachycardia substrate ablation

Intervention Type PROCEDURE

Study protocol

1. Baseline programmed ventricular stimulation performed from the LV
2. High density endocardial LV mapping using CARTO® 3 System
3. Randomized substrate ablation in half patients. Ablation end-point is considered the elimination of all endocardial late and early potentials (LPs and EPs)
4. Final programmed ventricular stimulation performed from the LV

Programmed ventricular stimulation with up to 4 extrastimuli from LV is performed and repeated at the end of the procedure in patients undergoing substrate ablation.

Control group

Control group will undergo substrate mapping

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ventricular tachycardia substrate ablation

Study protocol

1. Baseline programmed ventricular stimulation performed from the LV
2. High density endocardial LV mapping using CARTO® 3 System
3. Randomized substrate ablation in half patients. Ablation end-point is considered the elimination of all endocardial late and early potentials (LPs and EPs)
4. Final programmed ventricular stimulation performed from the LV

Programmed ventricular stimulation with up to 4 extrastimuli from LV is performed and repeated at the end of the procedure in patients undergoing substrate ablation.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Post-MI patients eligible for ICD implantation in the setting of primary prevention

Exclusion Criteria

1. NYHA IV or ambulatory NYHA IV
2. Acute coronary syndrome in the last 40 days
3. Stable angina not eligible to revascularization
4. Revascularization in the last 3 months (except MI)
5. Antiarrhythmic therapy other than b-blockers
6. LVEF\<20%
7. GFR\<30ml/min/1.73m2
8. Systematic illnesses

Eligible Sex

ALL

Accepts Healthy Volunteers

No