NCT02780947

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable heart-failure

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 24, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

May 24, 2016

Status Verified

May 1, 2016

Enrollment Period

4 years

First QC Date

May 19, 2016

Last Update Submit

May 19, 2016

Conditions

Heart FailureMyocardial InfarctionVentricular Tachycardia

Keywords

Ventricular tachycardiaAblationMyocardial InfarctionHeart Failure

Outcome Measures

Primary Outcomes (1)

  • 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.

    Within 3 years after ICD implantation

Study Arms (2)

Prophylactic substrate ablation group

ACTIVE COMPARATOR

Prophylactic substrate ablation group will undergo substrate mapping and ventricular tachycardia substrate ablation

Procedure: Ventricular tachycardia substrate ablation

Control group

NO INTERVENTION

Control group will undergo substrate mapping

Interventions

Ventricular tachycardia substrate ablationPROCEDURE

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.

Prophylactic substrate ablation group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Post-MI patients eligible for ICD implantation in the setting of primary prevention

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 31698933DERIVED

MeSH Terms

Conditions

Heart FailureMyocardial InfarctionTachycardia, Ventricular

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesMyocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisTachycardiaArrhythmias, CardiacCardiac Conduction System Disease

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Spyros Deftereos, MD

CONTACT

+306944699901spdeftereos@gmail.com

Dimitris Tsiachris, MD

CONTACT

+306944849926dtsiachris@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Cardiology

Study Record Dates

First Submitted

May 19, 2016

First Posted

May 24, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

May 24, 2016

Record last verified: 2016-05