Utility of ICD Electrograms During Ventricular Tachycardia Ablation

NCT ID: NCT02274168

Last Updated: 2022-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2022-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional RF catheter ablation

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

Group Type: OTHER

Conventional RF catheter ablation

Intervention Type: 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).

Investigational RF Catheter Ablation using ICD-EG information

RF Catheter Ablation will be performed using ICD-EG information

Group Type: OTHER

Investigational RF Catheter Ablation using ICD-EG information

Intervention Type: 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.

Interventions

Conventional RF catheter ablation

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).

Intervention Type: PROCEDURE

Investigational RF Catheter Ablation using ICD-EG information

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Hospital de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jesus Almendral, MD

Role: STUDY_DIRECTOR

HM hospitales

Locations

Hospital General Universitario

Alicante, , Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Hospital del Mar

Barcelona, , Spain

Hospital Universitario de Basurto

Bilbao, , Spain

Hospital Universitario de Burgos

Burgos, , Spain

Hospital Universitario Virgen de las Nieves

Granada, , Spain

Hospital Universitario Insular de Gran Canaria

Las Palmas, , Spain

HM Hospitales

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Hospital Universitario Virgen de la Arrixaca

Murcia, , Spain

Hospital Universitario Nuestra Señora de Valme

Seville, , Spain

Hospital Virgen de la Salud

Toledo, , Spain

Hospital Clínico Universitario

Valencia, , Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 20828650 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20828651 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22151407 (View on PubMed)

Other Identifiers

AIDEG-VTA

Identifier Type: -

Identifier Source: org_study_id