Clinical trial NCT02780947: Prophylactic Substrate Ablation in Post-myocardial Patients Undergoing Defibrillator Implantation.
Official title: Prophylactic Substrate Ablation in Post-myocardial Patients Undergoing Defibrillator Implantation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Myocardial Infarction
Ventricular Tachycardia
Keywords: Ventricular tachycardia
Ablation
Myocardial Infarction
Heart Failure
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
First posted: 2016-05-24
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Appropriate ICD activation therapies
timeFrame: Within 3 years after ICD implantation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Attikon Hospital, University of Athens
name: George Giannopoulos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Athens General Hospital "G. Gennimatas"
name: Charis Kossyvakis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Attikon Hospital, University of Athens
name: Spyros Deftereos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Athens Heart Center, Athens Medical Center
name: Dimitris Tsiachris, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kheiri B, Barbarawi M, Zayed Y, Hicks M, Osman M, Rashdan L, Kyi HH, Bachuwa G, Hassan M, Stecker EC, Nazer B, Bhatt DL. Antiarrhythmic Drugs or Catheter Ablation in the Management of Ventricular Tachyarrhythmias in Patients With Implantable Cardioverter-Defibrillators: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Circ Arrhythm Electrophysiol. 2019 Nov;12(11):e007600. doi: 10.1161/CIRCEP.119.007600. Epub 2019 Nov 8.