Left Atrial Arrhythmia Substrate Identification After Confirmed durABLE Pulmonary Vein Isolation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-03

Study Completion Date

2024-03-11

Brief Summary

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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.

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Detailed Description

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Persistent atrial fibrillation (PeAF) is defined as continuous atrial fibrillation for 7 days or more. Approximately 10% of people are diagnosed with atrial fibrillation (AF) by age 80 years; and among people of European descent, 26% of men and 23% of women have a lifetime risk of developing AF after age 40.

Catheter ablation by pulmonary vein isolation is the usual approach employed for PeAF. This involves making lesions within the pulmonary veins to achieve electrical isolation. Electrical isolation cuts off abnormal electrical triggers originating from the pulmonary veins. However, treatment outcomes are less than optimal with a lot of variability in success rates for different techniques. Hence, the optimal treatment strategy for patients with PeAF is not clear.

In this pilot study, investigators aim to study two different treatment modalities of catheter ablation: cold balloon (cryoballoon, Group 1) and hot tip (radiofrequency ablation, Group 2) used in (electrically) isolating the pulmonary veins. There will be 1:1 randomisation to either of the two modalities. All participants will subsequently undergo a repeat procedure 2 months later to identify reconnections and to re-isolate the veins using the hot tip (radiofrequency ablation) guided by an ultra-high density mapping technology. During the repeat procedure, investigators will perform further electrophysiological studies including assessing arrhythmia inducibility and measuring the extent of isolated areas. For participants in Group 2, investigators will also make some lesions in the back wall of the heart (posterior wall isolation) and recheck arrhythmia inducibility.

All participants will be given a handheld ECG recording (Omron) device. Participants will be shown how to use the device to make daily 30-second recordings and when they have symptoms, to be reviewed. Follow up will be at 3, 6 and 12 months.

Conditions

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Atrial Fibrillation Persistent Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group one

Cryoballoon pulmonary vein isolation

Group Type ACTIVE_COMPARATOR

Cryoballoon pulmonary vein isolation

Intervention Type 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.

Repeat electrophysiological study

Intervention Type 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

Group two

Radiofrequency pulmonary vein isolation

Group Type ACTIVE_COMPARATOR

Radiofrequency pulmonary vein isolation

Intervention Type 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

Repeat electrophysiological study

Intervention Type 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

Left atrial posterior wall isolation

Intervention Type 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

Interventions

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Cryoballoon pulmonary vein isolation

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.

Intervention Type PROCEDURE

Radiofrequency pulmonary vein isolation

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

Intervention Type PROCEDURE

Repeat electrophysiological study

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

Intervention Type PROCEDURE

Left atrial posterior wall isolation

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

Intervention Type PROCEDURE

Other Intervention Names

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Repeat catheter ablation Posterior wall isolation

Eligibility Criteria

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Inclusion Criteria

1. Age 18 to 80 years
2. Evidence of persistent Atrial Fibrillation

Exclusion Criteria

1. Any previous catheter (or surgical) ablation for atrial fibrillation or cryoballoon pulmonary vein isolation
2. An indwelling atrial septal defect (ASD) occluder device or anatomical structure that pre-vents free access to the left atrium
3. Left atrial diameter on transthoracic echo (Parasternal long axis, M-mode) \> 5.5cm
4. Recent stroke/Transient Ischaemic Attack within 3 months
5. Inability, unwillingness or absolute contraindication to taking oral anticoagulant medication
6. Severe kidney impairment (estimated Glomerular Filtration Rate \< 30ml/min)
7. Morbid obesity (Body Mass Index ≥40)
8. Extreme frailty
9. Severe valvular heart disease of any kind as assessed by the investigator, with or without prosthetic valve in place
10. Pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No