Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT05539040

The Role of Right Atrial Ectopy Triggering Ganglionated Plexuses in AF

Led by Imperial College London · Updated on 2023-09-28

116

Participants Needed

1

Research Sites

249 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Atrial fibrillation (AF) is the most common rhythm disturbance of the heart. It can affect people of any age but usually happens as we get older. It can cause palpitations, breathlessness, lethargy, and fainting attacks. It is also associated with an increased risk of strokes. The best treatment for it at the moment involves burning or freezing (ablation) the heart muscle in a part of the heart called the left atrium. The ablation injures the heart muscle around the so-called pulmonary veins and the procedure is called a 'pulmonary vein isolation'. This procedure work in about 60% of people. The study team have found that there are nerve endings in the heart that also cause AF and have shown that ablating these nerve endings also prevents AF. These Nerve endings are known as ganglionated plexuses (GPs). The study team would now like to perform a trial in people who still have AF after the usual pulmonary vein procedure. The study team hope that ablating the nerve endings that cause AF (GPs), we will stop their AF coming back. The study team will compare this procedure to the normal approach of doing the pulmonary vein isolation again

CONDITIONS

Official Title

The Role of Right Atrial Ectopy Triggering Ganglionated Plexuses in AF

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males or females from 18 to 85 years old
  • Symptomatic paroxysmal atrial fibrillation
  • Suitable candidate for catheter ablation
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Contraindication to catheter ablation
  • Contraindication for general anaesthetic
  • Presence of a left ventricular thrombus
  • Valvular disease that is grade moderate or greater
  • Any form of cardiomyopathy
  • Severe cerebrovascular disease
  • Active gastrointestinal bleeding
  • Serum Creatinine >200umol/L, on dialysis, or at risk of dialysis
  • Active infection or fever
  • Life expectancy shorter than the duration of the trial
  • Allergy to contrast
  • Moderate to severe heart failure and/or NYHA Class III-IV
  • Bleeding or clotting disorders or inability to receive heparin
  • Uncontrolled diabetes (HbA1c ≥73mmol/mol or HbA1c ≥64mmol/mol and Fasting Blood Glucose ≥9.2mmol/L)
  • Malignancy needing therapy
  • Pregnancy or women of childbearing potential not using a highly effective method of contraception
  • Unable to give informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hammersmith Hospital

London, United Kingdom, W12 0HS

Actively Recruiting

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Research Team

J

Jamie Kay, MBBS BMedSci

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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