Utility of ICD Electrograms During Ventricular Tachycardia Ablation

NCT02274168 | Completed DMC

• 1 other identifier: AIDEG-VTA
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 14

Brief Summary

With the increasing use of implantable cardioverter defibrillators (ICD) for primary prevention in patients with structural heart disease, an increasing number of patients are expected to develop their first episode of monomorphic ventricular tachycardia (VT) after an ICD is in place and the only documentation of the clinical arrhythmia will be the ICD electrogram (EG). The absence of a 12-lead ECG in patients with an ICD and sustained monomorphic VT represents a limitation when performing treatment with radiofrequency (RF) ablation. The analysis of ICD-EG during a RF ablation procedure is expected to provide a reference "model" of VT with clinical expression consisting of the electrical signal of the ICD during VT (which otherwise is not generally possible to obtain in ICD patients). This will allow for a more targeted approach to the substrate of the VT with clinical expression because: 1) if VT is induced by programmed stimulation, one can tell whether it is with clinical expression or not, and 2) if VT is not induced, ventricular pacing could be performed based on the comparative analysis of morphology and activation times of ICD-EG. These approaches will result in improved outcomes of the ablation procedure.

Conditions

Sustained Monomorphic Ventricular Tachycardia

Outcome Measures

Primary Outcomes (1)

• Percentage of patients free of VT recurrence

  6 months

Secondary Outcomes (4)

• Reduction in number of VT recurrence

  6 months

• Reduction in the proportion of patients free of VT recurrence

  6 months

• Reduction in the proportion of patients free of recurrence in patients in whom 12-lead ECG of the spontaneous VT is not available and in those in whom hemodinamically tolerated VT is not induced

  6 months and total follow-up

• Improvement of spatial resolution of the ICD-EG after information from local ventricular endocardial acceleration is added

  6 months

Study Arms (2)

Conventional RF catheter ablation

OTHER

Conventional RF ablation will be performed without using ICD-EG information

Procedure: Conventional RF catheter ablation

Investigational RF Catheter Ablation using ICD-EG information

OTHER

RF Catheter Ablation will be performed using ICD-EG information

Procedure: Investigational RF Catheter Ablation using ICD-EG information

Interventions

Conventional RF catheter ablation PROCEDURE

RF catheter ablation will be performed as usually done by each center. No ICD EGMs will be obtained and used during the ablation procedure (do not place the programming head over the ICD generator).

Conventional RF catheter ablation

Investigational RF Catheter Ablation using ICD-EG information PROCEDURE

RF ablation procedure will be performed with the programming head over the ICD generator. ICD EGMs will be registered every time VT is induced and during ventricular pacing. ICD EGMs obtained during ablation procedure will be compared with the EGMs of the registered spontaneus VT and used to locate appropriate ablation sites.

Investigational RF Catheter Ablation using ICD-EG information

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Clinical indication for RF catheter ablation
• Presence of an implanted ICD
• At least 1 episode of spontaneous sustained monomorphic VT documented with ICD electrogram
• Presence of structural heart disease
• Able to obtain signed informed consent and willing to comply with study activity requirements

You may not qualify if:

• It is anticipated that data can not be obtained during follow-up
• Unwilling or unable to provide informed consent
• Women who are or may potentially be pregnant
• Patients who are participating in another clinical trial

Sponsors & Collaborators

• Fundación Hospital de Madrid: lead

Study Sites (14)

Hospital General Universitario

Alicante, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Hospital Universitario de Basurto

Bilbao, Spain

Location

Hospital Universitario de Burgos

Burgos, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, Spain

Location

Hospital Universitario Insular de Gran Canaria

Las Palmas, Spain

Location

HM Hospitales

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Hospital Universitario Virgen de la Arrixaca

Murcia, Spain

Location

Hospital Universitario Nuestra Señora de Valme

Seville, Spain

Location

Hospital Virgen de la Salud

Toledo, Spain

Location

Hospital Clínico Universitario

Valencia, Spain

Location

Related Publications (3)

• Yoshida K, Liu TY, Scott C, Hero A, Yokokawa M, Gupta S, Good E, Morady F, Bogun F. The value of defibrillator electrograms for recognition of clinical ventricular tachycardias and for pace mapping of post-infarction ventricular tachycardia. J Am Coll Cardiol. 2010 Sep 14;56(12):969-79. doi: 10.1016/j.jacc.2010.04.043.

  PMID: 20828650 BACKGROUND

• Almendral J, Marchlinski F. Is it the same or a different ventricular tachycardia?: an additional use for defibrillator electrograms. J Am Coll Cardiol. 2010 Sep 14;56(12):980-2. doi: 10.1016/j.jacc.2010.03.081. No abstract available.

  PMID: 20828651 BACKGROUND

• Almendral J, Atienza F, Everss E, Castilla L, Gonzalez-Torrecilla E, Ormaetxe J, Arenal A, Ortiz M, Sanroman-Junquera M, Mora-Jimenez I, Bellon JM, Rojo JL. Implantable defibrillator electrograms and origin of left ventricular impulses: an analysis of regionalization ability and visual spatial resolution. J Cardiovasc Electrophysiol. 2012 May;23(5):506-14. doi: 10.1111/j.1540-8167.2011.02233.x. Epub 2011 Dec 8.

  PMID: 22151407 BACKGROUND

Study Officials

• Jesus Almendral, MD

  HM hospitales

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2014
• First Posted: October 24, 2014
• Study Start: April 1, 2011
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: December 13, 2022

Record last verified: 2022-12

Locations

ES (14)