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

Not Applicable

• Conditions: Heart Failure; Myocardial Infarction; Ventricular Tachycardia
• Interventions: Procedure: Ventricular tachycardia substrate ablation

• Registration Number: NCT02780947
• Lead Sponsor: Spyridon Deftereos

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2016-05
• Study First Submitted: 2016-05-19
• Study First Submitted QC: 2016-05-19
• Last Update Submitted: 2016-05-19
• Study First Posted: 2016-05-24
• Last Update Posted: 2016-05-24
• Study Start: 2016-06
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prophylactic substrate ablation group	Ventricular tachycardia substrate ablation	Prophylactic substrate ablation group will undergo substrate mapping and ventricular tachycardia substrate ablation

Primary Outcome Measures

Name	Time	Method
Appropriate ICD activation therapies	Within 3 years after ICD implantation	All post-MI patients will undergo ICD implantation and electroanatomical substrate mapping of the left ventricle. Half patients will also undergo prophylactic VT ablation aiming to late and early potentials elimination.; Post-MI patients who underwent ICD implantation in the setting of primary prevention and prophylactic substrate ablation will have significant less appropriate ICD therapies.