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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
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Spyridon Deftereos, National and Kapodistrian University of Athens

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

Condition or disease Intervention/treatment Phase
Heart Failure Myocardial Infarction Ventricular Tachycardia Procedure: Ventricular tachycardia substrate ablation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Prophylactic substrate ablation group
Prophylactic substrate ablation group will undergo substrate mapping and ventricular tachycardia substrate ablation
Procedure: 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.


No Intervention: Control group
Control group will undergo substrate mapping



Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02780947


Contacts
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Contact: Spyros Deftereos, MD +306944699901 spdeftereos@gmail.com
Contact: Dimitris Tsiachris, MD +306944849926 dtsiachris@gmail.com

Sponsors and Collaborators
Spyridon Deftereos
Biosense Webster, Inc.
Investigators
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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

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Responsible Party: Spyridon Deftereos, Associate Professor of Cardiology, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT02780947     History of Changes
Other Study ID Numbers: PREVENT-VT study
First Posted: May 24, 2016    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Spyridon Deftereos, National and Kapodistrian University of Athens:
Ventricular tachycardia
Ablation
Myocardial Infarction
Heart Failure
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Heart Failure
Myocardial Infarction
Infarction
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease