Left Atrial Arrhythmia Substrate Identification After Confirmed durABLE Pulmonary Vein Isolation

NCT04111731 | Completed

• 1 other identifier: 1200
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Atrial Fibrillation; Persistent Atrial Fibrillation

Keywords

Radiofrequency catheter ablation; Cryoballoon pulmonary vein isolation; Rhythmia; Orion catheter; Posterior wall isolation; Electrophysiological study; Omron device

Outcome Measures

Primary Outcomes (1)

• Number of late pulmonary vein re-connections

  Number of late pulmonary vein re-connections at repeat electrophysiological study as identified by ultra-high density mapping: comparison between the 80 pulmonary veins in each group

  Up to 2 months after index ablation procedure

Secondary Outcomes (9)

• Amount of radiofrequency energy needed to re-isolate the veins

  2 months after the index ablation procedure

• Area of low voltage

  2 months after the index ablation procedure

• Incidence of arrhythmia inducibility before and after left atrial posterior wall isolation

  2 months after the index ablation procedure

• Incidence of peri-procedural complications

  From index procedure to after repeat procedure

• Incidence of renal function impacting on left atrial electrical properties

  At the index procedure and 2 months after the index procedure

Study Arms (2)

Group one

ACTIVE COMPARATOR

Cryoballoon pulmonary vein isolation

Procedure: Cryoballoon pulmonary vein isolation; Procedure: Repeat electrophysiological study

Group two

ACTIVE COMPARATOR

Radiofrequency pulmonary vein isolation

Procedure: Radiofrequency pulmonary vein isolation; Procedure: Repeat electrophysiological study; Procedure: Left atrial posterior wall isolation

Interventions

Cryoballoon pulmonary vein isolation PROCEDURE

Catheter ablation using cryoballoon pulmonary vein isolation. Utilisation of a 'cold balloon' (Cryoenergy or cryoballoon ablation) to freeze the bases of the 4 pulmonary veins to achieve electrical isolation.

Group one

Radiofrequency pulmonary vein isolation PROCEDURE

Catheter ablation using radiofrequency energy to achieve pulmonary vein isolation. Radiofrequency energy is delivered through the tip of a catheter to make tiny burns (ablation lesions) around the outlines of the 4 pulmonary veins at their bases

Group two

Repeat electrophysiological study PROCEDURE

All participants will receive a repeat electrophysiological study 2 months after the index procedure during which radiofrequency catheter ablation guided by ultra-high density mapping will be used to identify regions of reconnection that need re-isolation; other tests will be carried out including testing for arrhythmia inducibility

Also known as: Repeat catheter ablation

Group one; Group two

Left atrial posterior wall isolation PROCEDURE

The left atrial posterior wall will be isolated in Group 2 participants (those who received radiofrequency ablation at the index procedure) during the repeat electrophysiological study in 2 months

Also known as: Posterior wall isolation

Group two

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 80 years
• Evidence of persistent Atrial Fibrillation

You may not qualify if:

• Any previous catheter (or surgical) ablation for atrial fibrillation or cryoballoon pulmonary vein isolation
• 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
• Recent stroke/Transient Ischaemic Attack within 3 months
• Inability, unwillingness or absolute contraindication to taking oral anticoagulant medication
• Severe kidney impairment (estimated Glomerular Filtration Rate \< 30ml/min)
• Morbid obesity (Body Mass Index ≥40)
• Extreme frailty
• Severe valvular heart disease of any kind as assessed by the investigator, with or without prosthetic valve in place
• Pregnancy

Sponsors & Collaborators

• Liverpool Heart and Chest Hospital NHS Foundation Trust: lead
• Boston Scientific Corporation: collaborator

Study Sites (3)

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, L14 3PE, United Kingdom

Location

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

The Newcastle Upon Tyne Hospital NHS Foundation Trust, Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dhiraj Gupta, MBBS MD FRCP

  Liverpool Heart and Chest Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomised, controlled multi-centre pilot study. Forty participants with persistent atrial fibrillation will have an equal chance of being randomised to receive either of two treatment techniques of pulmonary vein isolation: Cryoballoon (Group 1) or Radiofrequency ablation (Group 2). Subsequently, all patients will undergo a repeat procedure 2 months later to assess for reconnections requiring further treatment. In Group 2 participants, there will also be lesions made to the back wall of the heart (left atrial posterior wall isolation).

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: October 1, 2019
• Study Start: March 3, 2020
• Primary Completion: March 11, 2024
• Study Completion: December 22, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)