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Facilitating Catheter Guidance to Optimal Site for VT Ablation (CPS)

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ClinicalTrials.gov Identifier: NCT03862989
Recruitment Status : Not yet recruiting
First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Collaborators:
Medical Research Council
EPSRC
University Hospitals Bristol NHS Foundation Trust
Information provided by (Responsible Party):
University of Exeter

Brief Summary:

Each year in the UK, approximately 150,000 people have a heart attack when the blood supply to their heart is compromised. As a result, affected regions of the heart can become diseased and scarred. In a healthy person, electrical waves propagate across the heart in a regulated pattern which triggers contraction to pump blood around the body. The scar tissue that forms as a result of a heart attack can disrupt the propagation of the electrical waves. If significant disruptions occur, blood cannot be pumped out of the body effectively, leading to sudden death.

Ablation therapy aims to eliminate areas of diseased tissue that cause disruption to the heart rhythm, by applying radiofrequency using catheters inserted into the heart. The most accurate techniques used to locate the region to ablate require the induction of dangerous heart rhythms, which are only inducible in about 65% of people.

Pace mapping is a technique used to locate regions to ablate, which can be performed during normal heart rhythm. ECG data, which records electrical signals from the heart, is collected when the patient has an abnormal heart rhythm. From this template ECG, a clinician can tell the approximate location of the diseased tissue. A catheter is directed to that location, the heart stimulated, and another ECG, called the paced ECG is recorded. If the paced ECG matches the template ECG, it is assumed that the heart was paced in the location that requires ablation.

Current ablation techniques are difficult, time consuming, and inaccurate. As a result, the procedure may work in only half of all patients, and result in unnecessary damage to healthy tissue, leading to later impairment of heart function.

The CPS project's overall goal is to increase the success rates of ablation therapy by improving the accuracy and efficiency of locating the optimal region of tissue to eliminate during the pace mapping procedure. Increasing ablation therapy success rates will mean that patients will be unlikely to suffer from future heart rhythm disorders as a result of their heart attack, increasing the life expectancy of heart attack patients. Excess damage caused to the heart as a result of unnecessary ablation lesions will be limited, decreasing the likelihood of future complications. In addition, dangerous heart rhythms do not need to be induced in the patient, significantly decreasing the risk of death during the treatment.


Condition or disease Intervention/treatment
Post-myocardial Infarction Ventricular Tachycardia Procedure: Radiofrequency catheter ablation

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiac Positioning System (CPS) - a Navigation System to Guide Pace Mapping of Ischemic Scar During Catheter Ablation Therapy of Post-myocardial Infarction (MI) Ventricular Tachycardia (VT) in Adults
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : November 14, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack


Intervention Details:
  • Procedure: Radiofrequency catheter ablation
    A catheter is inserted into the heart and signals are recorded from the heart whilst at rest or whilst being stimulated by a catheter, in order to determine the site to ablate. Radiofrequency is then delivered to the target site in order to disrupt the pathological electrical activation which is causing the abnormal heart rhythm.


Primary Outcome Measures :
  1. Accuracy of scar region prediction [ Time Frame: 6 weeks ]
    The accuracy with which we can predict the region of the scar using the developed algorithm, in order to direct initial catheter placement to begin pace mapping.

  2. Speed in determining optimal ablation target site [ Time Frame: 6 weeks ]
    The speed with which the optimal target site for ablation is determined by the developed algorithm

  3. Accuracy in determining optimal ablation target site [ Time Frame: 6 weeks ]
    The accuracy with which the optimal target site for ablation is determined by the developed algorithm



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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 scheduled for radiofrequency catheter ablation of post-myocardial infarction ventricular tachycardia at Bristol Heart Institute
Criteria

Inclusion Criteria:

  • post-myocardial infarction ventricular tachycardia diagnosis
  • scheduled to undergo radiofrequency catheter ablation as either emergency or elective case

Exclusion Criteria:

  • Unable to perform pace mapping during ablation procedure
  • Unable to terminate VT thus unable to provide data regarding successful ablation lesion sites
  • Intracardiac thrombus

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): NCT03862989


Contacts
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Contact: Glyn Thomas 0117 342 6578 glyn.thomas@uhbristol.nhs.uk

Locations
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United Kingdom
Bristol Heart Institute
Bristol, United Kingdom, BS2 8HW
Sponsors and Collaborators
University of Exeter
Medical Research Council
EPSRC
University Hospitals Bristol NHS Foundation Trust
Investigators
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Principal Investigator: Yolanda Hill EPSRC Centre for Predictive Modelling in Healthcare, University of Exeter

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Responsible Party: University of Exeter
ClinicalTrials.gov Identifier: NCT03862989     History of Changes
Other Study ID Numbers: 1819/14
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease