Paroxysmal Atrial FibrillationWAVE-MAP AFNCT03882021
High-Density (HD) Wave Mapping in Subjects With Atrial Fibrillation as a Predictor of Recurrence After a Single Ablation Procedure Using a PVI-Only Strategy
A study testing A specific electrophysiology mapping protocol is applicable with the GRID catheter. in people with Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, run by Abbott Medical Devices at 15 sites in 9 countries.
Trial summary
The aim is to use the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ to characterize the atrial substrate and develop a model for predicting recurrence rates after a single procedure using a PVI only approach and a contact catheter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Cardiac Arrhythmia
- What is being tested?
- A specific electrophysiology mapping protocol is applicable with the GRID catheter.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 15 sitesin 9 countries
- Study dates
- 26 Aug 2019to 13 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented atrial fibrillation with planned endocardial ablation procedure
- Age 18 years or older
- Able and willing to provide written informed consent prior to any clinical investigation related procedure
- Able and willing to complete all required study procedures through 12 months
Who cannot join
- Long-standing persistent atrial fibrillation defined as continuous AF greater than 12 months in duration
- Previous ablation or surgery in the left atria
- Implanted left atrial appendage occluder
- Implanted mitral or tricuspid valve replacement
- Implanted cardiac defibrillator (ICD)
- Participation in another clinical investigation that may confound the results of this study
Show all 9Show fewer
- Pregnant or nursing
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
- Life expectancy less than 12 months
Trial locations and contacts
15 sites in 9 countries.
15 sites in 9 countries
France3 sites
Hôpital Privé du Confluent
Nantes, Paysdel, 44200
CHR de La Reunion - Site du CHFG
Saint-Denis, ILE, 97405
Médipôle Lyon-Villeurbanne
Villeurbanne, Rhone, 69626
Germany3 sites
Herz- u. Gefäßzentrum Bad Bevensen
Bad Bevensen, L Saxon, 29549
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, 32545
Klinikum Ingolstadt GmbH
Ingolstadt, Bavaria, 85049
Italy2 sites
Ospedale San Raffaele
Milan, Lombard, 20132
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, 56126
Spain2 sites
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Complexo Hospitalario Universitario de Santiago
Santiago de Compostela, Galicia, 15706
Netherlands1 site
Universitair Medische Centrum Groningen
Groningen, 9713 GZ
About this study
The aim is to use the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ to characterize the atrial substrate and develop a model for predicting recurrence rates after a single procedure using a PVI only approach and a contact catheter.
Read the detailed description
This clinical investigation is intended to characterize the left atrial substrate using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ in an HD Wave configuration and correlate different factors with 12-month success after a single ablation procedure using a pulmonary vein isolation (PVI) approach without further substrate modification.
This is a post-market, single-arm, multi-center, prospective interventional study of the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™. This study is aimed at determining correlations between pre-ablation mapping characteristics and outcomes after catheter ablation of atrial fibrillation.
Approximately 300 subjects at up to 20 sites worldwide will be enrolled.
Subjects will be followed until they complete their 12-month visit. Clinical Investigation visits will occur at Baseline (confirmation of eligibility), Index Procedure, 3 months, 6 months, and 12 months. Endpoints will be analyzed when all subjects have completed their 12-month follow up visits.
- Being tested
- A specific electrophysiology mapping protocol is applicable with the GRID catheter.
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A specific electrophysiology mapping protocol is applicable with the GRID catheter.Procedure or surgery
The procedure will be done according to a standard ablation approach. During the electrophysiology study, additional mapping data will be collected to support the study endpoints using the GRID catheter.
| Study group | Role | What they receive |
|---|---|---|
| Mapping protocol with Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (GRID) catheter | Other | All patient will undergo a protocol required mapping protocol using the GRID catheter. Receives: Procedure: A specific electrophysiology mapping protocol is applicable with the GRID catheter. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With One-year Success
Defined as freedom from atrial fibrillation, atrial flutter and atrial tachycardia after removal from the antiarrhythmic drug therapy as assesses from the end of the 3-month blanking period to 12 months following a single ablation procedure. Kaplan-Meier survival analysis will be conducted to analyze time-to-event variables.
Measured: the end of the 3-month blanking period to 12 months following a single ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start26 Aug 2019
- Primary completion30 Nov 2021
- Study completion13 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects enrolled will undergo the same mapping and ablation protocol.
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristin Ruffner, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882021
- Sponsor's protocol ID
- ABT-CIP-10275
- Acronym
- WAVE-MAP AF
- Status last verified
- Apr 2024
- First submitted
- 7 Mar 2019
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Density (HD) Wave Mapping in Subjects With Atrial Fibrillation as a Predictor of Recurrence After a Single Ablation Procedure Using a PVI-Only Strategy
- ClinicalTrials.gov ID
- NCT03882021
- Acronym / sponsor ID
- WAVE-MAP AF / ABT-CIP-10275
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 13 Jan 2022 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim is to use the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ to characterize the atrial substrate and develop a model for predicting recurrence rates after a single procedure using a PVI only approach and a contact catheter.
Detailed description
This clinical investigation is intended to characterize the left atrial substrate using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ in an HD Wave configuration and correlate different factors with 12-month success after a single ablation procedure using a pulmonary vein isolation (PVI) approach without further substrate modification.
This is a post-market, single-arm, multi-center, prospective interventional study of the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™. This study is aimed at determining correlations between pre-ablation mapping characteristics and outcomes after catheter ablation of atrial fibrillation.
Approximately 300 subjects at up to 20 sites worldwide will be enrolled.
Subjects will be followed until they complete their 12-month visit. Clinical Investigation visits will occur at Baseline (confirmation of eligibility), Index Procedure, 3 months, 6 months, and 12 months. Endpoints will be analyzed when all subjects have completed their 12-month follow up visits.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects enrolled will undergo the same mapping and ablation protocol.
| Arm | Type | Receives |
|---|---|---|
| Mapping protocol with Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (GRID) catheter | Other | Procedure: A specific electrophysiology mapping protocol is applicable with the GRID catheter.All patient will undergo a protocol required mapping protocol using the GRID catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Documented atrial fibrillation with planned endocardial ablation procedure
- Age 18 years or older
- Able and willing to provide written informed consent prior to any clinical investigation related procedure
- Able and willing to complete all required study procedures through 12 months
Key exclusion criteria (9 listed)
- Long-standing persistent atrial fibrillation defined as continuous AF greater than 12 months in duration
- Previous ablation or surgery in the left atria
- Implanted left atrial appendage occluder
- Implanted mitral or tricuspid valve replacement
- Implanted cardiac defibrillator (ICD)
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 |
|---|---|---|
| A specific electrophysiology mapping protocol is applicable with the GRID catheter.The procedure will be done according to a standard ablation approach. During the electrophysiology study, additional mapping data will be collected to support the study endpoints using the GRID catheter. | Procedure or surgery | Mapping protocol with Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (GRID) catheter |
Primary outcome
Percentage of Subjects With One-year Success
Time frame: the end of the 3-month blanking period to 12 months following a single ablation procedure
Defined as freedom from atrial fibrillation, atrial flutter and atrial tachycardia after removal from the antiarrhythmic drug therapy as assesses from the end of the 3-month blanking period to 12 months following a single ablation procedure. Kaplan-Meier survival analysis will be conducted to analyze time-to-event variables.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Paroxysmal Atrial Fibrillation
Recruiting
Renal Denervation in Patients With Atrial Fibrillation and Hypertension
Atrial Fibrillation (Paroxysmal), Hypertension
Recruiting
Conscious Sedation Versus General Anesthesia for Pulsed Field Ablation in Paroxysmal Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Recruiting
Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation
Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation
Not yet recruiting
A Global Randomized Trial Evaluating the FARAFLEX™ Mapping and Pulsed Field Ablation System With Electrographic Flow Mapping in Patients Undergoing Repeat Ablation for Atrial Fibrillation
Atrial Fibrillation (AF), Persistent Atrial Fibrillation (PersAF)
Recruiting
Feasibility Study of the FARAFLEX Mapping and PFA System
Atrial Fibrillation, Persistent Atrial Fibrillation
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.
Kristin Ruffner study director
Abbott
15 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A specific electrophysiology mapping protocol is applicable with the GRID catheter. in people with Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, run by Abbott Medical Devices at 15 sites in 9 countries.
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 9 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France, Germany, Italy, Spain, Austria and 4 more countries. 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?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Subjects With One-year Success (time frame: the end of the 3-month blanking period to 12 months following a single ablation procedure). 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 19 Sep 2024.