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Not yet recruiting NCT07454135

Mechanisms of Atrial Pathoelectrophysiology in HCM

Observational Hypertrophic Cardiomyopathy (HCM) Atrial Fibrillation (AF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hypertrophic Cardiomyopathy (HCM), Atrial Fibrillation (AF). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • 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]
Secondary outcome measures (2)
  • 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]
  • Reduction in AF inducibility in silico models following simulated ablation [Time frame: Based on measurements taken during the clinical ablation procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United Kingdom · 1 center
  • Guy's and St Thomas' NHS Foundation Trust — London

Identifiers

NCT: NCT07454135 · 339394

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗