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.
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
- Type of treatment
- Medical device, Surgery or procedure
- 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
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
- Conditions
- Atrial Fibrillation
- 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 group | Role | What they receive |
|---|---|---|
| Group A - Standard Care | Active comparator | The 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 mapping | Experimental | The 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.
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)
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)
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)
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)
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)
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)
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)
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)
Percentage of patients suffering symptomatic PV stenosis
Proportion of patients coming back within 3 months with symptomatic PV stenosis
Measured: 3 months
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.
- First posted28 Sep 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2018
- 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
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Boon Lim, Principal investigator, Imperial College London
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a High Density Mapping System to Complete Wide Area Circumferential Ablation of the Pulmonary Veins and Avoid Ostial Segmental Ablation
- ClinicalTrials.gov ID
- NCT02917044
- Acronym / sponsor ID
- HD-WACA / 15HH2466
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment issues due to competing studies. Higher than expected PVI on first pass. Sample would have to be increased which was not feasible.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Mar 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - Standard Care | Active comparator | Procedure: Atrial Fibrillation Ablation, Device: Catheters used to isolate pulmonary veinsThe 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. |
| Group B - Rhythmia mapping | Experimental | Device: Catheters used to isolate pulmonary veins, Procedure: Atrial Fibrillation Ablation with HD mapping to isolate PVs, Device: Rhythmia HD mappingThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ECG documented AF
- Listed for AF ablation by referring physician
- Planned ablation includes a first-time PVI.
- Patient signed informed consent form
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atrial Fibrillation AblationProcedure involving catheter ablation to produce pulmonary vein isolation. Pulmonary veins are isolated by assessing electrograms circumferentially around the PV using the Orion catheter. | Procedure or surgery | Group A - Standard Care |
| Catheters used to isolate pulmonary veinsCatheters 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. | Device | Group A - Standard Care, Group B - Rhythmia mapping |
| Atrial Fibrillation Ablation with HD mapping to isolate PVsProcedure 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. | Procedure or surgery | Group B - Rhythmia mapping |
| Rhythmia HD mappingMapping activation patterns using the Rhythmia system in conjunction with the Orion catheter | Device | Group B - Rhythmia mapping |
Primary outcome
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)
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.
Total number of radiofrequency ablation lesions to produce isolation of veins per WACA
Time frame: Procedural - i.e. assessed over procedure duration only (about 3 hours)
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.
8 secondary outcomes
Whether ostial ablation is required in each case (Yes/No)
Time frame: Procedural - i.e. assessed over procedure duration only (about 3 hours)
Number of radiofrequency ablation lesions required within the WACA lesion set
Time frame: Procedural - i.e. assessed over procedure duration only (about 3 hours)
Total radiofrequency ablation time (in mins) within the WACA lesion set
Time frame: Procedural - i.e. assessed over procedure duration only (about 3 hours)
Total number of radiofrequency ablation lesions required to produce PV isolation per patient
Time frame: Procedural - i.e. assessed over procedure duration only (about 3 hours)
Total procedural time (in mins) required to produce PV isolation
Time frame: Procedural - i.e. assessed over procedure duration only (about 3 hours)
Percentage of patients with successful PV isolation
Time frame: Procedural - i.e. assessed over procedure duration only (about 3 hours)
Percentage of patients suffering symptomatic PV stenosis
Time frame: 3 months
Percentage of patients with AF recurrence
Time frame: 3 months
Results and safety
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.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boon Lim principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
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.