NCT04111731Completed
Left Atrial Arrhythmia Substrate Identification After Confirmed durABLE Pulmonary Vein Isolation
Left Atrial Arrhythmia Substrate Identification by Ultra-high Density Mapping After Confirmed durABLE Pulmonary Vein Isolation
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
Under current practice, patients with persistent atrial fibrillation, can be offered one of two types of ablation treatment. Both of these treatments are aimed at electrically isolating the 4 pulmonary veins (PVs) at the back of the heart which connect it to the lungs. These PVs have been identified to serve as the sites where the abnormal heart rhythm is generated. One of the treatments is called radiofrequency (RF) catheter ablation, where 'heat energy' is delivered through the tip of a catheter to make tiny burns (ablation lesions) around the outlines of the 4 PVs at their bases. The other treatment technique utilises a 'cold balloon' (Cryoenergy or cryoballoon ablation) to freeze the bases of the 4 PVs to achieve the electrical isolation. Sometimes the treated tissues develop reconnections that can lead to a recurrence of the abnormal heart rhythm, and thus the need for a repeat procedure. In this study, participants will receive a second treatment 2 months after the first one. During the second treatment, investigators will check to identify areas that have developed reconnections since the first treatment; these will be treated again. This will increase the chances of all participants having a complete treatment. In order to improve understanding of how best to treat this condition, investigators will also carry out some further measurements within the heart during the repeat procedure. During these measurements, investigators will check to see if treatment has succeeded in reducing the occurrence of an abnormal heart rhythm. In the group of participants in whom RF energy is used for the initial procedure, investigators will also treat the back wall of the heart, and repeat these measurements.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 44 (actual)
- First submitted
- 3 Apr 2019
- Start date
- 3 Mar 2020
- Primary completion date
- 11 Mar 2024
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation Trust
- Diseases
- Atrial fibrillation
- NCT number
- NCT04111731
What you commit to
- Study type: Interventional
- Participants enrolled: 44
- From 3 Mar 2020 to the primary completion date, 11 Mar 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any previous catheter (or surgical) ablation for atrial fibrillation or cryoballoon pulmonary vein isolation
- Inability, unwillingness or absolute contraindication to taking oral anticoagulant medication
Other illness
- Recent stroke/Transient Ischaemic Attack within 3 months
- Severe kidney impairment (estimated Glomerular Filtration Rate \< 30ml/min)
- Severe valvular heart disease of any kind as assessed by the investigator, with or without prosthetic valve in place
Other
- An indwelling atrial septal defect (ASD) occluder device or anatomical structure that pre-vents free access to the left atrium
- Left atrial diameter on transthoracic echo (Parasternal long axis, M-mode) \> 5.5cm
- Morbid obesity (Body Mass Index ≥40)
- Extreme frailty
- Pregnancy
Who the study is looking for
- Age 18 to 80 years
- Evidence of persistent Atrial Fibrillation
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Liverpool Heart and Chest Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| Manchester University NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| The Newcastle Upon Tyne Hospital NHS Foundation Trust, Freeman Hospital Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.