NCT07454135

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
14mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Mar 2026Sep 2027

First Submitted

Initial submission to the registry

March 2, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

March 8, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

March 2, 2026

Last Update Submit

March 2, 2026

Conditions

Keywords

hypertrophic cardiomyopathyatrial fibrillation

Outcome Measures

Primary Outcomes (1)

  • Changes in electrophysiological properties of the atria in patients with HCM and AF compared to patients with AF and structurally normal hearts

    At the time of the clinical ablation procedure

Secondary Outcomes (2)

  • Correlatation between the electrophysiological changes in the atria with directly measured left atrial pressure, extent of late gadolinium enhancement and ventricular extracellular volume .

    At the time of clinical ablation procedure

  • Response to various ablation strategies applied in patient specific computational models.

    Based on measurements taken during the clinical ablation procedure

Study Arms (1)

Patients with HCM and AF

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with hypertrophic cardiomyopathy and atrial fibrillation requiring atrial fibrillation ablation.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Cardiomyopathy, HypertrophicAtrial Fibrillation

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2026

First Posted

March 6, 2026

Study Start

March 8, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations