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Atrial FibrillationHD-WACANCT02917044

Use of a High Density Mapping System to Complete Wide Area Circumferential Ablation of the Pulmonary Veins and Avoid Ostial Segmental Ablation

A study testing Atrial Fibrillation Ablation, Catheters used to isolate pulmonary veins and Atrial Fibrillation Ablation with HD mapping to isolate PVs in people with Atrial Fibrillation, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Atrial Fibrillation
What is being tested?
Atrial Fibrillation Ablation, Catheters used to isolate pulmonary veins and Atrial Fibrillation Ablation with HD mapping to isolate PVs
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited Kingdom
Study dates
Mar 2016to Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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%

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Hammersmith Hospital

    London, Please Select Region, State Or Province, W120HS

Other trials in United Kingdom

About this study

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

Read the 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

Being tested
Atrial Fibrillation Ablation, Catheters used to isolate pulmonary veins, Atrial Fibrillation Ablation with HD mapping to isolate PVs, Rhythmia HD mapping
Keywords
Atrial Fibrillation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atrial Fibrillation AblationProcedure or surgery

    Procedure involving catheter ablation to produce pulmonary vein isolation. Pulmonary veins are isolated by assessing electrograms circumferentially around the PV using the Orion catheter.

  • Catheters used to isolate pulmonary veinsDevice

    Catheters transiently inserted into body via femoral veins in order to produce pulmonary vein isolation. These catheters are the same in each arm and comprise the Orion catheter (Boston Scientific) and the Tacticath (St Jude) which are used to produce pulmonary vein isolation and which are approved for use in standard EP procedures by the relevant authorities (CE marked). It is merely the protocol by which they are used that iffers in the two arms.

  • Atrial Fibrillation Ablation with HD mapping to isolate PVsProcedure or surgery

    Procedure involving catheter ablation to produce pulmonary vein isolation. Pulmonary veins are isolated by use of electroanatomical mapping with the Orion catheter around the sites ablation in order to target points of breakthrough.

  • Rhythmia HD mappingDevice

    Mapping activation patterns using the Rhythmia system in conjunction with the Orion catheter

Study groups in NCT02917044
Study groupRoleWhat they receive
Group A - Standard CareActive comparatorThe operator will attempt to complete the WACA lesion set using standard techniques. These include ablating any obvious gaps in the lesion set, ablating at the WACA line in a location radial to the earliest PV signal measured by the Orion catheter situated within the PV, and guided by amplitude and dV/dt of signals along the WACA lesion set measured using the mapping catheter. If this fails the operator will resort to OSA as per their usual practice.
Receives: Procedure: Atrial Fibrillation Ablation; Device: Catheters used to isolate pulmonary veins
Group B - Rhythmia mappingExperimentalThe operator will form Rhythmia maps focussing on the region of the WACA line surrounding the non-isolated vein(s) whilst pacing from CS. This will be used as a means of targeting RF ablation to gaps in the WACA line (in addition to use of standard observation of signals as per group A). If this fails then the operator will resort to OSA as per their usual practice.
Receives: Device: Catheters used to isolate pulmonary veins; Procedure: Atrial Fibrillation Ablation with HD mapping to isolate PVs; Device: Rhythmia HD mapping

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total time in minutes required to produce isolation of veins per WACA

    Following first pass ablation with WACA, if either vein is not isolated the patient will be randomized into group A or B. The total RF time taken to isolate the veins for that WACA will be measured as one of 2 joint primary outcome measures.

    Measured: Procedural - i.e. assessed over procedure duration only (about 3 hours)

  2. Total number of radiofrequency ablation lesions to produce isolation of veins per WACA

    Following first pass ablation with WACA, if either vein is not isolated the patient will be randomized into group A or B. The total number of lesions (each lesion being 30s in duration) to isolate the veins for that WACA will be measured as one of two joint primary outcome measures.

    Measured: Procedural - i.e. assessed over procedure duration only (about 3 hours)

Secondary outcomes (8)
  1. Whether ostial ablation is required in each case (Yes/No)

    This is a measure of whether ostial ablation (undesirable) will be required (yes/no). It is assessed during procedure.

    Measured: Procedural - i.e. assessed over procedure duration only (about 3 hours)

  2. Number of radiofrequency ablation lesions required within the WACA lesion set

    The number of oostial lesions required in each case (number of ablation lesions)

    Measured: Procedural - i.e. assessed over procedure duration only (about 3 hours)

  3. Total radiofrequency ablation time (in mins) within the WACA lesion set

    This is the total ablation time (in mins) within the WACA required to produce PV isolation

    Measured: Procedural - i.e. assessed over procedure duration only (about 3 hours)

  4. Total number of radiofrequency ablation lesions required to produce PV isolation per patient

    As per primary endpoint but on a per patient rather than per vein basis

    Measured: Procedural - i.e. assessed over procedure duration only (about 3 hours)

  5. Total procedural time (in mins) required to produce PV isolation

    Whether procedure time (in mins) is different in group A vs group B

    Measured: Procedural - i.e. assessed over procedure duration only (about 3 hours)

  6. Percentage of patients with successful PV isolation

    Proportion of veins successfully isolated with the contrasting techniques

    Measured: Procedural - i.e. assessed over procedure duration only (about 3 hours)

  7. Percentage of patients suffering symptomatic PV stenosis

    Proportion of patients coming back within 3 months with symptomatic PV stenosis

    Measured: 3 months

  8. Percentage of patients with AF recurrence

    Proportion of patients remaining AF free at 3 months as analysed per Kaplan-Meier format

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionMar 2018
  4. Study completionJun 2018

Why it stopped: Recruitment issues due to competing studies. Higher than expected PVI on first pass. Sample would have to be increased which was not feasible.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02917044
Sponsor's protocol ID
15HH2466
Acronym
HD-WACA
Status last verified
Oct 2019
First submitted
5 Aug 2016
Last updated
8 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Atrial Fibrillation Ablation, Catheters used to isolate pulmonary veins and Atrial Fibrillation Ablation with HD mapping to isolate PVs in people with Atrial Fibrillation, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Recruitment issues due to competing studies. Higher than expected PVI on first pass. Sample would have to be increased which was not feasible.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total time in minutes required to produce isolation of veins per WACA (time frame: Procedural - i.e. assessed over procedure duration only (about 3 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2019.

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