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R Wave Sensing After VT Ablation (RASA-VT)

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ClinicalTrials.gov Identifier: NCT03779165
Recruitment Status : Not yet recruiting
First Posted : December 18, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Ivan Zeljkovic, University Hospital "Sestre Milosrdnice"

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.


Condition or disease
Tachycardia, Ventricular Catheter Ablation Follow-Up Studies Electrodes

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: R Wave Sensing After Radiofrequency Ablation of Ventricular Tachycardia Substrate in Patients With Structural Heart Disease
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. R wave sensing change [ Time Frame: immediately after the ablation procedure ]
    R wave sensing drop > 30% after RF ablation of VT substrate in left and/or right ventricle assessed by ventricular electrode of the CIED


Secondary Outcome Measures :
  1. R wave sensing change 24h follow-up [ Time Frame: 24 hours after ablation procedure ]
    R wave sensing drop > 30% after RF ablation of VT substrate in left and/or right ventricle assessed by ventricular electrode of the CIED

  2. R wave sensing change 3-6 month follow-up [ Time Frame: 3-6 months after ablation procedure ]
    R wave sensing drop > 30% after RF ablation of VT substrate in left and/or right ventricle assessed by ventricular electrode of the CIED

  3. R wave sensing change 9-12 month follow-up [ Time Frame: 9-12 months after the ablation procedure ]
    R wave sensing drop > 30% after RF ablation of VT substrate in left and/or right ventricle assessed by ventricular electrode of the CIED

  4. Incidence of VT recurrence after the ablation procedure [ Time Frame: 12 months after the ablation procedure ]
    Assessing the VT recurrence after the ablation procedure by ICD or CRT-D interrogation adn function testing

  5. Risk factors for R wave sensing change after the RF ablation of VT substrate [ Time Frame: 12 months ]
    assessing risk factors for R wave sensing drop after the RF ablation of VT substrate



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03779165


Contacts
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Contact: Ivan Zeljkovic, MD 0038513787733 ivanzeljkov@gmail.com
Contact: Nikola Pavlovic, MD 0038513787111 nikolap12@yahoo.com

Locations
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Croatia
University Hospital Rijeka Not yet recruiting
Rijeka, Croatia, 51000
Contact: Sandro Brusich, MD    0038551658111    sandro.brusich@gmail.com   
University Hospital Sestre milosrdnice Not yet recruiting
Zagreb, Croatia, 10000
Contact: Ivan Zeljkovic, MD    0038513787733    ivanzeljkov@gmail.com   
Switzerland
University Hospital Basel Not yet recruiting
Basel, Switzerland, 4031
Contact: Christian Sticherling, MD    +41 61 265 44 44    christian.sticherling@usb.ch   
University Hospital Bern
Bern, Switzerland, 3012
Sponsors and Collaborators
University Hospital "Sestre Milosrdnice"
Investigators
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Principal Investigator: Ivan Zeljkovic, MD University Hospital "Sestre Milosrdnice"

Additional Information:

Publications of Results:
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Responsible Party: Ivan Zeljkovic, Principal Investigator, University Hospital "Sestre Milosrdnice"
ClinicalTrials.gov Identifier: NCT03779165     History of Changes
Other Study ID Numbers: ZAPSA01
UTN U1111-1223-2331 ( Other Identifier: Universal Trial Number - World Health Organization )
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ivan Zeljkovic, University Hospital "Sestre Milosrdnice":
ventricular tachycardia
R wave; sensing
radiofrequency ablation
follow-up
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes