Persistent Atrial FibrillationNCT02991313
Evaluation of a Multi-electrode Linear Type Catheter (D-1368-01-SI)
A study testing Endocardial Ablation Procedure in people with Persistent Atrial Fibrillation, run by Biosense Webster, Inc..
Trial summary
The purpose of this trial is to assess acute safety and performance of the Multi-electrode Linear Type Catheter in conjunction with generator software V2.4.0 or above when used for the treatment of Persistent Atrial Fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Endocardial Ablation Procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 30 Nov 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
- Age > 18 years.
- Signed the Patient Informed Consent Form (ICF)
- Documented ongoing or previous symptomatic persistent AF (by physician's note indicating continuous AF ≥ 7 days)
- Failed at least one antiarrhythmic drug (AAD) (class I or III) as evidenced by recurrent symptomatic AF, or intolerable to the AAD.
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements.
Who cannot join
- Previous surgical or catheter ablation for atrial fibrillation
- Current condition of continuous AF > 12 months (1 year) (Longstanding Persistent AF) or previously diagnosed as having Longstanding Persistent AF
- Any carotid stenting or endarterectomy
- Known with Cardioversion refractory history (the inability to restore sinus rhythm for 30 secs or longer following electrical cardioversion.
- LA size > 55 mm
- LVEF <40%
Show all 25Show fewer
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- Significant pulmonary disease (i.e. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms
- Uncontrolled heart failure or NYHA function class III and IV
- MI within the past 2 months
- Any cardiac surgery (i.e. CABG) within the past 2 months
- Subjects that have ever undergone valvular cardiac surgical/ percutaneous procedure (ie, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
- Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
- Documented thromboembolic event (including TIA) within the past 12 months
- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
- Active illness or active systemic infection or sepsis
- Unstable angina
- History of blood clotting or bleeding abnormalities
- Contraindication to anticoagulation (eg, heparin or warfarin)
- Life expectancy less than 12 months
- Presence of intracardiac thrombus, myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation
- Presence of a condition that precludes vascular access
- Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation
- Currently enrolled in another device, biologics, or drug study
- Contraindication for use of the investigational devices , as indicated in the respective Instructions For Use
About this study
Official title: Evaluation of a Multi-electrode Linear Type Catheter (D-1368-01-SI) for Endocardial Ablation of Patients With Persistent Atrial Fibrillation (LME-167)
The purpose of this trial is to assess acute safety and performance of the Multi-electrode Linear Type Catheter in conjunction with generator software V2.4.0 or above when used for the treatment of Persistent Atrial Fibrillation.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Endocardial Ablation Procedure
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endocardial Ablation ProcedureDevice
Also called Linear Type Catheter (D-1368-01-SI), nMARQ TM Multi-channel RF generator (D-1341-07) with Software V2.4.0 or above, Linear Ablation Connection Cable (M-5948-01-I)
| Study group | Role | What they receive |
|---|---|---|
| Endocardial Ablation Procedure | Experimental | ablation with Linear type catheter Receives: Device: Endocardial Ablation Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Onset of Primary Adverse Events
Incidence of early onset (within 7 days of ablation procedure) primary Adverse Events
Measured: Within 7 days
Confirmation of entrance block
Acute procedural success defined as: Confirmation of entrance block in all targeted PVs after adenosine and /or isoproterenol challenge (taking into account a 30 minute waiting period from the last RF application at a PV target before verification)
Measured: Intraoperative
Confirmation of bi-directional block
Acute procedural success defined as: Confirmation of bi-directional block in all linear lesions
Measured: Intraoperative
Secondary outcomes (2)
Incidence of Serious Adverse Device Effects (SADEs)
Incidence of Serious Adverse Device Effects (SADEs) during follow-up
Measured: 1 Year
Freedom from documented Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia
Freedom from documented Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia recurrence at 3, 6 and 12 months post-procedure
Measured: 3, 6 and 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study start1 Oct 2016
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biosense Webster, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991313
- Sponsor's protocol ID
- LME-167
- Status last verified
- Jan 2025
- First submitted
- 28 Nov 2016
- Last updated
- 3 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Multi-electrode Linear Type Catheter (D-1368-01-SI) for Endocardial Ablation of Patients With Persistent Atrial Fibrillation (LME-167)
- ClinicalTrials.gov ID
- NCT02991313
- Acronym / sponsor ID
- LME-167
- Conditions
- Persistent Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Biosense Webster, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 13 Dec 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.
The purpose of this trial is to assess acute safety and performance of the Multi-electrode Linear Type Catheter in conjunction with generator software V2.4.0 or above when used for the treatment of Persistent Atrial Fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endocardial Ablation Procedure | Experimental | Device: Endocardial Ablation Procedureablation with Linear type catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years.
- Signed the Patient Informed Consent Form (ICF)
- Documented ongoing or previous symptomatic persistent AF (by physician's note indicating continuous AF ≥ 7 days)
- Failed at least one antiarrhythmic drug (AAD) (class I or III) as evidenced by recurrent symptomatic AF, or intolerable to the AAD.
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements.
Key exclusion criteria (25 listed)
- Previous surgical or catheter ablation for atrial fibrillation
- Current condition of continuous AF > 12 months (1 year) (Longstanding Persistent AF) or previously diagnosed as having Longstanding Persistent AF
- Any carotid stenting or endarterectomy
- Known with Cardioversion refractory history (the inability to restore sinus rhythm for 30 secs or longer following electrical cardioversion.
- LA size > 55 mm
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 |
|---|---|---|
| Endocardial Ablation ProcedureAlso: Linear Type Catheter (D-1368-01-SI), nMARQ TM Multi-channel RF generator (D-1341-07) with Software V2.4.0 or above, Linear Ablation Connection Cable (M-5948-01-I) | Device | Endocardial Ablation Procedure |
Primary outcome
Early Onset of Primary Adverse Events
Time frame: Within 7 days
Incidence of early onset (within 7 days of ablation procedure) primary Adverse Events
Confirmation of entrance block
Time frame: Intraoperative
Acute procedural success defined as: Confirmation of entrance block in all targeted PVs after adenosine and /or isoproterenol challenge (taking into account a 30 minute waiting period from the last RF application at a PV target before verification)
Confirmation of bi-directional block
Time frame: Intraoperative
Acute procedural success defined as: Confirmation of bi-directional block in all linear lesions
2 secondary outcomes
Incidence of Serious Adverse Device Effects (SADEs)
Time frame: 1 Year
Freedom from documented Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia
Time frame: 3, 6 and 12 months post-procedure
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 3 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Endocardial Ablation Procedure in people with Persistent Atrial Fibrillation, run by Biosense Webster, Inc..
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 5 inclusion and 25 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 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Onset of Primary Adverse Events (time frame: Within 7 days). 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 3 Feb 2025.