- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07454135
Mechanisms of Atrial Pathoelectrophysiology in HCM (MAP HCM)
This study aims to learn why atrial fibrillation (AF), a type of irregular heartbeat, happens more often and is harder to treat in people with hypertrophic cardiomyopathy (HCM). HCM is an inherited condition where the heart muscle is thicker than usual.
Researchers will study electrical signals from the heart and advanced heart imaging. By doing this, they hope to better understand how AF behaves in people with HCM and why treatments may not work as well for them.
The information from this study may help improve future treatments for people who have both HCM and AF.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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London, United Kingdom
- Guy's and St Thomas' NHS Foundation Trust
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Contact:
- Magdalena Klis
- Phone Number: 02071887188
- Email: magda.klis@kcl.ac.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Paroxysmal or persistent atrial fibrillation
- Diagnosis of hypertrophic cardiomyopathy
- Patient planning to proceed to atrial fibrillation ablation following clinical consultation
- Age 18-80 years
- Able and willing to provide written informed consent
- Able and willing to comply with study follow up requirements
Exclusion Criteria:
- Any clinical contra-indication to ablation
- Any disease limiting life expectancy to <1 year
- Potential participant currently pregnant or breast feeding
- Contraindication to MRI including renal dysfunction (eGFR<30ml/min)
- Unable to understand verbal or written explanations given in English
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patients with HCM and AF
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Changes in bipolar voltage, conduction velocity, refractory periods and conduction divergence of the atria in patients with HCM and AF compared to patients with AF and structurally normal hearts
Time Frame: At the time of the clinical ablation procedure
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At the time of the clinical ablation procedure
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Correlatation between the bipolar voltage in the atria with directly measured left atrial pressure, extent of late gadolinium enhancement and ventricular extracellular volume .
Time Frame: At the time of clinical ablation procedure
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At the time of clinical ablation procedure
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Reduction in AF inducibility in silico models following simulated ablation
Time Frame: Based on measurements taken during the clinical ablation procedure
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Based on measurements taken during the clinical ablation procedure
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 339394
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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