Facilitating Catheter Guidance to Optimal Site for VT Ablation
NCT ID: NCT03862989
Last Updated: 2021-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2021-05-01
2021-11-01
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* scheduled to undergo radiofrequency catheter ablation as either emergency or elective case
Exclusion Criteria
* Unable to terminate VT thus unable to provide data regarding successful ablation lesion sites
* Intracardiac thrombus
18 Years
ALL
No
Sponsors
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Medical Research Council
OTHER_GOV
EPSRC
UNKNOWN
University Hospitals Bristol and Weston NHS Foundation Trust
OTHER
University of Exeter
OTHER
Responsible Party
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Principal Investigators
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Yolanda Hill
Role: PRINCIPAL_INVESTIGATOR
EPSRC Centre for Predictive Modelling in Healthcare, University of Exeter
Locations
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Bristol Heart Institute
Bristol, , United Kingdom
Countries
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Other Identifiers
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1819/14
Identifier Type: -
Identifier Source: org_study_id