R Wave Sensing After VT Ablation

NCT03779165 | Unknown

• 2 other identifiers: ZAPSA01UTN U1111-1223-2331
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 4

Brief Summary

Sustained, monomorphic ventricular tachycardia (VT) is most commonly encountered in patients with structural heart disease, usually with ischemic aetiology. It has been proven that repeated episodes of sustained VT contribute to the mortality of patients with structural heart disease. These patients are usually implanted with implantable cardioverter defibrillator without (ICD) or with cardiac resynchronisation therapy (CRT-D). According to the current guidelines 3D mapping with radiofrequency (RF) ablation of the tachycardia substrate is an established therapeutic option. As part of the clinical follow-up of patients implanted with cardiac implantable electronic devices (CIED), CIED function parameters are monitored every 6 months, which is always done before and after any procedure involving RF ablation. Furthermore, a transient drop of R wave sensing has been demonstrated after the atrioventricular (AV) node ablation in patients with single-chamber pacemakers and fast atrial fibrillation. The aim of this study is to assess the change in R wave sensing after the RF ablation of VT substrate. This study will be performed as a clinical, prospective, multi-centre, observational cohort study with a structured follow-up period of 12 months. All consecutive patients with sustained VT implanted with ICD or CRT-D undergoing RF ablation procedure of myocardial substrate, who are able to understand and sign informed consent, will be enrolled. Primary objective is a R wave sensing drop \> 30% after VT substrate ablation procedure. Recruiting should not exceed 12 months with the minimal follow-up period of 12 months (24 months in total). Standardized statistical methods and test will be done using SPSS Software Version 22.0 or newer. This unique study offers the possibility to show the impact of RF ablation on short-term and long-term R wave sensing change assessed by ICD or CRT-D's ventricle electrode in patients with sustained VT and structural heart disease undergoing ablation procedure. This observational data is needed to further refine the treatment of these patients and to prevent possible ICD/CRT-D dysfunction which could endanger this patient population.

Conditions

Tachycardia, Ventricular; Catheter Ablation; Follow-Up Studies; Electrodes

Keywords

ventricular tachycardia; R wave; sensing; radiofrequency ablation; follow-up

Outcome Measures

Primary Outcomes (1)

• R wave sensing change

  R wave sensing drop \> 30% after RF ablation of VT substrate in left and/or right ventricle assessed by ventricular electrode of the CIED

  immediately after the ablation procedure

Secondary Outcomes (5)

• R wave sensing change 24h follow-up

  24 hours after ablation procedure

• R wave sensing change 3-6 month follow-up

  3-6 months after ablation procedure

• R wave sensing change 9-12 month follow-up

  9-12 months after the ablation procedure

• Incidence of VT recurrence after the ablation procedure

  12 months after the ablation procedure

• Risk factors for R wave sensing change after the RF ablation of VT substrate

  12 months

Eligibility Criteria

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

Study Population

Patients with structural heart disease (ischemic and non-ischemic aetiology) implanted with implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy cardioverter defibrillator (CRT-D) and recurrent, sustained, monomorphic ventricular tachycardia, who are, according to their cardiologist, planned for 3D mapping and radiofrequency ablation of ventricular tachycardia myocardial substrate.

You may qualify if:

• patients with recurrent, sustained ventricular tachycardia
• patients implanted with implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy cardioverter defibrillator (CRT-D)
• patients planned for 3D mapping and radiofrequency ablation of ventricular tachycardia myocardial substrate
• patients who are able to understand and sign informed consent

You may not qualify if:

• Patients with combined mechanical aortic and mitral valve prostheses
• Patients with RF ablation of VT done in the last 12 months
• Patients with known damaged ICD/CRT-D electrode or battery
• Patients undergoing VT ablation who have not been implanted with ICD or CRT-D
• Patients not willing or able to undergo clinical follow-up of ICD/CRT-D device
• Patients with life expectancy \< 1 year
• Not able to understand or willing to sign informed consent
• Age \< 18 years

Sponsors & Collaborators

• University Hospital Sestre Milosrdnice: lead

Study Sites (4)

University Hospital Rijeka

Rijeka, 51000, Croatia

Location

University Hospital Sestre milosrdnice

Zagreb, 10000, Croatia

Location

University Hospital Basel

Basel, 4031, Switzerland

Location

University Hospital Bern

Bern, 3012, Switzerland

Location

Related Publications (2)

• Darrat YH, Agarwal A, Morales GX, Thompson J, Abdel-Latif A, Waespe K, DI Biase L, Natale A, Patwardan A, Elayi CS. Radiofrequency and Cryo-Ablation Effect on Transvenous Pacing and Defibrillatory Lead Integrity: An In Vitro Study. J Cardiovasc Electrophysiol. 2016 Aug;27(8):976-80. doi: 10.1111/jce.13007. Epub 2016 Jun 14.

  PMID: 27138905 RESULT

• Priori SG, Blomstrom-Lundqvist C, Mazzanti A, Blom N, Borggrefe M, Camm J, Elliott PM, Fitzsimons D, Hatala R, Hindricks G, Kirchhof P, Kjeldsen K, Kuck KH, Hernandez-Madrid A, Nikolaou N, Norekval TM, Spaulding C, Van Veldhuisen DJ; Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC)Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC). Europace. 2015 Nov;17(11):1601-87. doi: 10.1093/europace/euv319. Epub 2015 Aug 29. No abstract available.

  PMID: 26318695 RESULT

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ivan Zeljkovic, MD

  University Hospital Sestre Milosrdnice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivan Zeljkovic, MD

CONTACT

0038513787733; ivanzeljkov@gmail.com

Nikola Pavlovic, MD

CONTACT

0038513787111; nikolap12@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 19, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: December 20, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2); CR (2)