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

May 19, 2016 updated by: Spyridon Deftereos
Prophylactic substrate ablation in post-MI patients undergoing defibrillator implantation reduces appropriate defibrillator therapies.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 3 years after ICD implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spyridon Deftereos

Collaborators

Biosense Webster, Inc.

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

May 19, 2016

First Submitted That Met QC Criteria

May 19, 2016

First Posted (Estimate)

May 24, 2016

Study Record Updates

Last Update Posted (Estimate)

May 24, 2016

Last Update Submitted That Met QC Criteria

May 19, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREVENT-VT study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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