Clinical trial NCT02917044: Use of a High Density Mapping System to Complete Wide Area Circumferential Ablation of the Pulmonary Veins and Avoid Ostial Segmental Ablation
Official title: Use of a High Density Mapping System to Complete Wide Area Circumferential Ablation of the Pulmonary Veins and Avoid Ostial Segmental Ablation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Lead sponsor: Imperial College Healthcare NHS Trust
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2016-09-28
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, multicentre, randomized single blind, parallel group study to be conducted in the UK (2 sites).Approximately 48 patients will be recruited aiming for 40 eligible for randomization. The study is designed to compare the operator's best attempt at WACA completion with and without Rhythmia guidance

Detailed description: BACKGROUND Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia occurring in 1-2% of the general population. AF can be associated with debilitating symptoms and confers an increased risk of death, stroke, heart failure and hospitalization. As such there is a need for effective therapies for AF. In particularly catheter based therapies, which can limit the need for chronic drug therapy, are becoming more widely accepted.

The development of AF requires both a trigger and susceptible substrate. Ectopic activity originating within the pulmonary veins (PVs) is a widely recognised factor in the genesis of paroxysmal AF, whilst electrical, contractile and structural remodelling of atrial myocardium are each important contributing factors to the arrhythmogenic substrate in AF.

An early strategy in paroxysmal AF (PAF) was to target ectopic triggers coming from the PV via ostial segmental ablation (OSA). Here radiofrequency (RF) ablation was applied close to the PV ostia at sites of early signals, usually until PVs were electrically isolated from the left atrium (LA). This approach resulted in a success rate, with regard to freedom from AF after a single procedure, of 65-90% after 1 year but closer to 50% after 5 years. The recognition of PV stenosis as a complication of RF delivery within a PV, as well as the recognition that initiation sites could be located in the antrum led to a shift in ablation strategy towards wider encirclement of the PVs using wide area circumferential ablation (WACA) using electroanatomical mapping to guide RF delivery. This resulted in improved success rates in a head-to-head comparison with OSA and it is possible that this relates to substrate modification inherent in this approach.

Recurrence of AF remains problematic following ablation. Pulmonary vein reconnection after ablation is thought to contribute to the majority of recurrent episodes of AF in paroxysmal AF. Electrical isolation of the PVs is often not achievable with WACA alone - 95% of patients had residual connections following WACA alone in one study. Most clinicians at this juncture will look for any obvious gaps in the line and ablate if there are early PV signals. If this is unsuccessful then it is often necessary to resort to OSA to achieve PV isolation. In essence a large proportion of PV isolation procedures, which started with a WACA strategy, are in fact a hybrid of WACA and OSA. This both has the potential to increase the complication rate by risking PV stenosis and reducing efficacy through omitting important substrate modification and allowing residual connection of part of the antrum and the LA.

The introduction of Rhythmia, a novel electroanatomical mapping system with the potential to rapidly acquire high density electroanatomical data, may allow an alternative strategy and more efficient targeting of gaps in WACA lines. The pilot data shows that the system is particularly adept in assessing gaps in ablation lines including WACA lines. Mapping and targeting such gaps may hold the key to efficiently completing PV isolation after an initial WACA line is performed.

RATIONALE FOR CURRENT STUDY Research Question: Can ostial segmental ablation be avoided during a wide area circumferential ablation (WACA) by using the Rhythmia high density mapping system? Hypothesis: The current study is designed to test the hypothesis that high density mapping using Rhythmia can enhance the operator's ability to electrically isolate PVs without unnecessary excessive ablation or OSA

Eligibility criteria: Inclusion Criteria:

* ECG documented AF
* Listed for AF ablation by referring physician
* Planned ablation includes a first-time PVI.
* Patient signed informed consent form

Exclusion Criteria:

* Age \<18 or \>80
* LA diameter \>60mm
* AF secondary to transient correctible abnormalits (e.g. electrolyte imbalance, thyrotoxicosis, recent infective or inflammatory process)
* Intra-atrial thrombus or tumour
* Renal failure requiring haemodialysis
* Heart failure with NYHA III-IV or EF\<35%

Primary outcomes:
measure: Total time in minutes required to produce isolation of veins per WACA
timeFrame: Procedural - i.e. assessed over procedure duration only (about 3 hours)
measure: Total number of radiofrequency ablation lesions to produce isolation of veins per WACA
timeFrame: Procedural - i.e. assessed over procedure duration only (about 3 hours)
Secondary outcomes:
measure: Whether ostial ablation is required in each case (Yes/No)
timeFrame: Procedural - i.e. assessed over procedure duration only (about 3 hours)
measure: Number of radiofrequency ablation lesions required within the WACA lesion set
timeFrame: Procedural - i.e. assessed over procedure duration only (about 3 hours)
measure: Total radiofrequency ablation time (in mins) within the WACA lesion set
timeFrame: Procedural - i.e. assessed over procedure duration only (about 3 hours)
measure: Total number of radiofrequency ablation lesions required to produce PV isolation per patient
timeFrame: Procedural - i.e. assessed over procedure duration only (about 3 hours)
measure: Total procedural time (in mins) required to produce PV isolation
timeFrame: Procedural - i.e. assessed over procedure duration only (about 3 hours)
measure: Percentage of patients with successful PV isolation
timeFrame: Procedural - i.e. assessed over procedure duration only (about 3 hours)
measure: Percentage of patients suffering symptomatic PV stenosis
timeFrame: 3 months
measure: Percentage of patients with AF recurrence
timeFrame: 3 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Hospital
state: Please Select Region, State Or Province
Study officials:
affiliation: Imperial College London
name: Boon Lim
role: PRINCIPAL_INVESTIGATOR
References: