Prophylactic Substrate Ablation in Post-myocardial Patients Undergoing Defibrillator Implantation.
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|ClinicalTrials.gov Identifier: NCT02780947|
Recruitment Status : Not yet recruiting
First Posted : May 24, 2016
Last Update Posted : May 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Myocardial Infarction Ventricular Tachycardia||Procedure: Ventricular tachycardia substrate ablation||Not Applicable|
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 .
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) . Catheter ablation has been considered a plausible curative therapy for VT prevention, especially in patients with VT episodes . 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 .
Aim of the study - Statement of Hypothesis Prophylactic substrate ablation in post-MI patients undergoing defibrillator implantation reduces appropriate defibrillator therapies.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prophylactic Substrate Ablation in Post-myocardial Patients Undergoing Defibrillator Implantation.|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Active Comparator: Prophylactic substrate ablation group
Prophylactic substrate ablation group will undergo substrate mapping and ventricular tachycardia substrate ablation
Procedure: Ventricular tachycardia substrate ablation
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.
No Intervention: Control group
Control group will undergo substrate mapping
- Appropriate ICD activation therapies [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02780947
|Contact: Spyros Deftereos, MDfirstname.lastname@example.org|
|Contact: Dimitris Tsiachris, MDemail@example.com|
|Principal Investigator:||George Giannopoulos, MD||Attikon Hospital, University of Athens|
|Principal Investigator:||Charis Kossyvakis, MD||Athens General Hospital "G. Gennimatas"|
|Principal Investigator:||Spyros Deftereos, MD||Attikon Hospital, University of Athens|
|Principal Investigator:||Dimitris Tsiachris, MD||Athens Heart Center, Athens Medical Center|