Prophylactic Substrate Ablation in Post-myocardial Patients Undergoing Defibrillator Implantation.
Primary Purpose
Heart Failure, Myocardial Infarction, Ventricular Tachycardia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ventricular tachycardia substrate ablation
Sponsored by
About this trial
This is an interventional prevention trial for Heart Failure focused on measuring Ventricular tachycardia, Ablation, Myocardial Infarction, Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Post-MI patients eligible for ICD implantation in the setting of primary prevention
Exclusion Criteria:
- NYHA IV or ambulatory NYHA IV
- Acute coronary syndrome in the last 40 days
- Stable angina not eligible to revascularization
- Revascularization in the last 3 months (except MI)
- Antiarrhythmic therapy other than b-blockers
- LVEF<20%
- GFR<30ml/min/1.73m2
- Systematic illnesses
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Prophylactic substrate ablation group
Control group
Arm Description
Prophylactic substrate ablation group will undergo substrate mapping and ventricular tachycardia substrate ablation
Control group will undergo substrate mapping
Outcomes
Primary Outcome Measures
Appropriate ICD activation therapies
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02780947
First Posted
May 19, 2016
Last Updated
May 19, 2016
Sponsor
Spyridon Deftereos
Collaborators
Biosense Webster, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02780947
Brief Title
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
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Spyridon Deftereos
Collaborators
Biosense Webster, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Myocardial Infarction, Ventricular Tachycardia
Keywords
Ventricular tachycardia, Ablation, Myocardial Infarction, Heart Failure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prophylactic substrate ablation group
Arm Type
Active Comparator
Arm Description
Prophylactic substrate ablation group will undergo substrate mapping and ventricular tachycardia substrate ablation
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group will undergo substrate mapping
Intervention Type
Procedure
Intervention Name(s)
Ventricular tachycardia substrate ablation
Intervention Description
Study protocol
Baseline programmed ventricular stimulation performed from the LV
High density endocardial LV mapping using CARTO® 3 System
Randomized substrate ablation in half patients. Ablation end-point is considered the elimination of all endocardial late and early potentials (LPs and EPs)
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.
Primary Outcome Measure Information:
Title
Appropriate ICD activation therapies
Description
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.
Time Frame
Within 3 years after ICD implantation
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Post-MI patients eligible for ICD implantation in the setting of primary prevention
Exclusion Criteria:
NYHA IV or ambulatory NYHA IV
Acute coronary syndrome in the last 40 days
Stable angina not eligible to revascularization
Revascularization in the last 3 months (except MI)
Antiarrhythmic therapy other than b-blockers
LVEF<20%
GFR<30ml/min/1.73m2
Systematic illnesses
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Spyros Deftereos, MD
Phone
+306944699901
Email
spdeftereos@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dimitris Tsiachris, MD
Phone
+306944849926
Email
dtsiachris@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Giannopoulos, MD
Organizational Affiliation
Attikon Hospital, University of Athens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charis Kossyvakis, MD
Organizational Affiliation
Athens General Hospital "G. Gennimatas"
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Spyros Deftereos, MD
Organizational Affiliation
Attikon Hospital, University of Athens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dimitris Tsiachris, MD
Organizational Affiliation
Athens Heart Center, Athens Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31698933
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.
Results Reference
derived
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Prophylactic Substrate Ablation in Post-myocardial Patients Undergoing Defibrillator Implantation.
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