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'Understanding the Electrophysiological Substrate Underlying Persistent Atrial Fibrillation Study II (USURP AF- Study II)' (USURPAF)

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ClinicalTrials.gov Identifier: NCT04041778
Recruitment Status : Recruiting
First Posted : August 1, 2019
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
University of Leicester

Brief Summary:

Atrial fibrillation (AF) is the most common type of chronic heart rhythm disease worldwide, with significant associated co-morbidities. Although there have been advances in understanding the mechanisms of AF, the underlying cause of AF and factors which perpetuate it remain incompletely understood. This is particularly the case for persistent AF (persAF). Drug treatments for persAF have a role but can have undesirable side effects with relatively limited efficacy. Furthermore, current invasive therapies for persAF remain suboptimal, requiring significant resources, and with potentially serious complications for patients.

Catheter ablation is an effective treatment for paroxysmal AF. For persistent AF (persAF), however, catheter ablation does not provide similar results. This is because there remains a poor understanding of the electrophysiological mechanisms driving persAF. Part of this study aims to further explore the specific locations that represent important substrates which would guide more effective catheter ablation. There have been several different ablation approaches explored in the past (see below), however, these did not improve the outcome post procedure compared with pulmonary vein isolation alone. A pilot study has already been carried out and I aim to expand this further with a larger cohort of patients (10-20) over 2 years. In this study the investigators want to explore whether stable high dominant frequency (HDF) sites (with a high organisation index) act as potential drivers of Atrial Fibrillation. Thus, targeting these sites may results in prolongation of the cycle length and thus possible termination of the arrhythmia.


Condition or disease Intervention/treatment
Atrial Fibrillation Mechanisms Persistent Atrial Fibrillation Substrate Ablation Pulmonary Vein Isolation Non-contact Mapping Other: Catheter ablation

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Understanding the Electrophysiological Substrate Underlying Persistent Atrial Fibrillation Study II (USURP AF- Study II)'
Actual Study Start Date : July 25, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Catheter ablation
    Substrate ablation. Pulmonary vein isolation.


Primary Outcome Measures :
  1. Termination to sinus rhythm [ Time Frame: in procedure ]
  2. Slowing of cycle length by greater than or equal to 20milliseconds [ Time Frame: in procedure ]
  3. Termination of AF in to an organised atrial tachyarrhythmia [ Time Frame: in procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will have been diagnosed with Persistent Atrial Fibrillation (persAF). They will have been listed for a first time persAF ablation as part of standard routine care.
Criteria

Inclusion Criteria:

  • Must be aged 18 years or over
  • Must be able to communicate in written and spoken English
  • Must be able to give signed informed consent.
  • All patients must be defined as having persistent atrial fibrillation (AF > 7 days) and must be in AF at the start of the procedure.
  • The patient preferably should be undergoing AF ablation for the first time, however repeat ablations can be permitted.
  • The patient must be listed for persistent AF ablation as part of standard clinical care.

Exclusion Criteria:

  • Symptoms secondary to ischaemic or valvular heart disease
  • Congenital heart disease
  • Previous history of a cardiac arrhythmia (other than AF, atrial tachycardia, atrial flutter).
  • Previous cardiothoracic surgery
  • Underlying severe respiratory disease (i.e. patient on long term oxygen therapy)
  • Medical conditions which will affect cardiac rhythm, even if treated (e.g. thyroxine, etc.)
  • Presence of chest deformity.
  • Left atrial dilatation (L or R atrial end-diastolic dimension > 4.5cm in any conventional plane of measurement on 2D transthoracic echocardiography).
  • Presence of implantable cardiac defibrillator or pacemaker (including cardiac resynchronisation devices).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04041778


Contacts
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Contact: Ghulam Andre Ng, MBChB, PhD. 0116 250 2438 ext 2438 andre.ng@leicester.ac.uk
Contact: Bharat Sidhu, MBChB 0116 250 2366 ext 2366 bs283@le.ac.uk

Locations
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United Kingdom
University Hospitals Leicester NHS Foundation Trust, Glenfield Hospital Recruiting
Leicester, United Kingdom, LE3 9QP
Contact: Bharat Sidhu, MBChB    0116 258 2366 ext 2366    bs283@le.ac.uk   
Sponsors and Collaborators
University of Leicester
Investigators
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Principal Investigator: Ghulam Andre Ng, MBChB, PhD. Professor of Electrophysiology University Hospitals Leicester
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Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT04041778    
Other Study ID Numbers: 0689
First Posted: August 1, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes