Non-paroxysmal Atrial FibrillationNCT02656537
EnSite™ HD Grid Catheter AF/AT Mapping Study
A study testing EnSite™ HD Grid Catheter mapping system in people with Non-paroxysmal Atrial Fibrillation and Left Atrial Tachycardia, run by Abbott Medical Devices at 7 sites in 5 countries.
Trial summary
In this clinical investigation, the safety, feasibility and performance of the novel EnSite™ HD Grid Catheter mapping system for advanced high-density three-dimensional mapping will be studied in patients undergoing catheter ablation procedures for the treatment of non-paroxysmal atrial fibrillation (AF) or left… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-paroxysmal Atrial Fibrillation, Left Atrial Tachycardia
- What is being tested?
- EnSite™ HD Grid Catheter mapping system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 7 sitesin 5 countries
- Study dates
- Aug 2015to Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of non-paroxysmal atrial fibrillation (AF) or left atrial tachycardia (AT) referred for catheter ablation
- Age of 18 years of age or older at time of Enrollment
- On continuous anticoagulation (INR 2-3) for >4 weeks prior to the ablation
- Able and willing to provide written informed consent to participate in this clinical investigation
Who cannot join
- Secondary atrial fibrillation (AF)
- Presence of a prosthetic valve(s) or hemodynamically significant valvular heart disease as determined by Study Investigator
- Active systemic infection (e.g. sepsis)
- Presence of left atrial thrombus (i.e., positive TEE) or myxoma, or interatrial baffle or patch via the transseptal approach
- Contraindication to systemic anticoagulation (i.e., heparin, warfarin, or a direct thrombin inhibitor)
- History of cerebrovascular accidents (Stroke, TIA)
Show all 15Show fewer
- Previous myocardial infarction, unstable angina pectoris or coronary artery by-pass <180 days at Enrollment or cardiovascular intervention expected in the 180 days post-Enrollment
- Left atrial size >55mm
- NYHA (New York Heart Association Classification) functional class III or IV heart failure
- Left ventricular ejection fraction <35%
- Uncontrolled Hyperthyroidism
- Pregnant or of childbearing potential and not using adequate contraceptive methods or nursing
- Participating in another clinical investigation that may confound the results of this clinical investigation
- Life expectancy less than 12 months, as determined by Study Investigator
- Severe clinical condition (e.g. active carcinoma) that, in the opinion of the Study Investigator, excludes the participation in the study
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
Australia3 sites
Royal Adelaide Hospital
Adelaide
Ashford Hospital
Ashford, 5035
Royal Melbourne Hospital
Parkville, 3050
About this study
Official title: EnSite™ HD Grid Catheter Mapping System for Advanced High Density Three-Dimensional Mapping in Non-Paroxysmal Atrial Fibrillation and Atrial Tachycardia
In this clinical investigation, the safety, feasibility and performance of the novel EnSite™ HD Grid Catheter mapping system for advanced high-density three-dimensional mapping will be studied in patients undergoing catheter ablation procedures for the treatment of non-paroxysmal atrial fibrillation (AF) or left atrial tachycardia (AT).
Read the detailed description
Catheter ablation for non-paroxysmal AF is more complex as triggers, if present at all, are not immediately apparent, but the abnormal atrial substrates are the likely predominant mechanisms. Additional catheter ablation strategies targeting for atrial substrate modification have been introduced. The common strategies involve either application of empirical linear lesion sets in the atrial areas or ablation of atrial areas with complex fractionated atrial electrograms in addition to pulmonary vein isolation. Nevertheless, the corresponding success rates in long-term sinus rhythm maintenance are modest.
Non-paroxysmal AF and left AT are characterized by fast and regular atrial activities, complex fractionated atrial electrograms, consistent direction of wave front propagation, and low peak-to-peak voltage. Advanced high-density three-dimensional catheter mapping strategies to target the evaluation of these characteristics and mechanisms responsible for the AF and left AT, identification of atrial areas with low peak-to-peak voltages and determination of the "critical" atrial targets for catheter ablation during the procedures would be essential.
In this clinical investigation, the safety, feasibility and performance of the novel EnSite™ HD Grid Catheter mapping system for advanced high-density three-dimensional mapping will be studied in patients undergoing catheter ablation procedures for the treatment of non-paroxysmal AF or left AT.
- Being tested
- EnSite™ HD Grid Catheter mapping system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnSite™ HD Grid Catheter mapping systemDevice
| Study group | Role | What they receive |
|---|---|---|
| EnSite™ HD Grid Catheter AF/AT Mapping | Experimental | Not described Receives: Device: EnSite™ HD Grid Catheter mapping system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events associated with the use of the EnSite™ HD (High-Density)Grid Catheter mapping system.
To evaluate the safety of the novel EnSite™ HD Grid Catheter mapping system by collecting intra- and post-Procedure (within 48 hours from Procedure) adverse events.
Measured: Within 48 hours from Procedure
Number of subjects with the electrophysiological characteristics of non-paroxysmal AF and left AT pre-catheter ablation studied using the EnSite™ HD Grid Catheter mapping system.
To identify and study the electrophysiological characteristics of non-paroxysmal AF and left AT pre-catheter ablation using a novel EnSite™ HD Grid Catheter mapping system.
Measured: During Procedure
Catheter performance during the mapping portion of the procedure
To assess the HD Grid Catheter mapping system for acceptable geometry creation, map repeatability and electrogram signal quality.
Measured: During Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startAug 2015
- Primary completionFeb 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-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
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlo Pappone, MD, PhD, Principal investigator, San Donato Hospital, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656537
- Sponsor's protocol ID
- CRD772
- Status last verified
- Jan 2019
- First submitted
- 16 Nov 2015
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EnSite™ HD Grid Catheter Mapping System for Advanced High Density Three-Dimensional Mapping in Non-Paroxysmal Atrial Fibrillation and Atrial Tachycardia
- ClinicalTrials.gov ID
- NCT02656537
- Acronym / sponsor ID
- CRD772
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Aug 2015 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 15 Jan 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.
In this clinical investigation, the safety, feasibility and performance of the novel EnSite™ HD Grid Catheter mapping system for advanced high-density three-dimensional mapping will be studied in patients undergoing catheter ablation procedures for the treatment of non-paroxysmal atrial fibrillation (AF) or left atrial tachycardia (AT).
Detailed description
Catheter ablation for non-paroxysmal AF is more complex as triggers, if present at all, are not immediately apparent, but the abnormal atrial substrates are the likely predominant mechanisms. Additional catheter ablation strategies targeting for atrial substrate modification have been introduced. The common strategies involve either application of empirical linear lesion sets in the atrial areas or ablation of atrial areas with complex fractionated atrial electrograms in addition to pulmonary vein isolation. Nevertheless, the corresponding success rates in long-term sinus rhythm maintenance are modest.
Non-paroxysmal AF and left AT are characterized by fast and regular atrial activities, complex fractionated atrial electrograms, consistent direction of wave front propagation, and low peak-to-peak voltage. Advanced high-density three-dimensional catheter mapping strategies to target the evaluation of these characteristics and mechanisms responsible for the AF and left AT, identification of atrial areas with low peak-to-peak voltages and determination of the "critical" atrial targets for catheter ablation during the procedures would be essential.
In this clinical investigation, the safety, feasibility and performance of the novel EnSite™ HD Grid Catheter mapping system for advanced high-density three-dimensional mapping will be studied in patients undergoing catheter ablation procedures for the treatment of non-paroxysmal AF or left AT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EnSite™ HD Grid Catheter AF/AT Mapping | Experimental | Device: EnSite™ HD Grid Catheter mapping system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Presence of non-paroxysmal atrial fibrillation (AF) or left atrial tachycardia (AT) referred for catheter ablation
- Age of 18 years of age or older at time of Enrollment
- On continuous anticoagulation (INR 2-3) for >4 weeks prior to the ablation
- Able and willing to provide written informed consent to participate in this clinical investigation
Key exclusion criteria (15 listed)
- Secondary atrial fibrillation (AF)
- Presence of a prosthetic valve(s) or hemodynamically significant valvular heart disease as determined by Study Investigator
- Active systemic infection (e.g. sepsis)
- Presence of left atrial thrombus (i.e., positive TEE) or myxoma, or interatrial baffle or patch via the transseptal approach
- Contraindication to systemic anticoagulation (i.e., heparin, warfarin, or a direct thrombin inhibitor)
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 |
|---|---|---|
| EnSite™ HD Grid Catheter mapping system | Device | EnSite™ HD Grid Catheter AF/AT Mapping |
Primary outcome
Number of subjects with adverse events associated with the use of the EnSite™ HD (High-Density)Grid Catheter mapping system.
Time frame: Within 48 hours from Procedure
To evaluate the safety of the novel EnSite™ HD Grid Catheter mapping system by collecting intra- and post-Procedure (within 48 hours from Procedure) adverse events.
Number of subjects with the electrophysiological characteristics of non-paroxysmal AF and left AT pre-catheter ablation studied using the EnSite™ HD Grid Catheter mapping system.
Time frame: During Procedure
To identify and study the electrophysiological characteristics of non-paroxysmal AF and left AT pre-catheter ablation using a novel EnSite™ HD Grid Catheter mapping system.
Catheter performance during the mapping portion of the procedure
Time frame: During Procedure
To assess the HD Grid Catheter mapping system for acceptable geometry creation, map repeatability and electrogram signal quality.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
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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.
Carlo Pappone, MD, PhD principal investigator
San Donato Hospital, Italy
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EnSite™ HD Grid Catheter mapping system in people with Non-paroxysmal Atrial Fibrillation and Left Atrial Tachycardia, run by Abbott Medical Devices at 7 sites in 5 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 15 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 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, France, Germany, Hong Kong, Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of subjects with adverse events associated with the use of the EnSite™ HD (High-Density)Grid Catheter mapping system. (time frame: Within 48 hours from Procedure). The study lists 3 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 1 Feb 2019.