Cavotricuspid Isthmus Dependent Right Atrial FlutterPhase 1NCT02257060
LINEAR II - LME-159 Evaluation of a Multi-Electrode Linear Type Ablation Catheter
A Phase 1 study testing Endocardial Ablation in people with Cavotricuspid Isthmus Dependent Right Atrial Flutter, run by Biosense Webster, Inc..
Trial summary
The Linear II study is a prospective, single center, non-randomized, interventional feasibility study with the purpose of assessing acute safety of the Multi-Electrode Linear Type Ablation Catheter and the performance of the product when used for the treatment of symptomatic CTI (cavotricuspid isthmus) dependent right… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cavotricuspid Isthmus Dependent Right Atrial Flutter
- What is being tested?
- Endocardial Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to May 2015
- Phase
- Phase 1
- 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
- At least one symptomatic episode of typical CTI dependent right atrial flutter documented by 12 lead ECG, Holter monitor, transtelephonic event monitor, telemetry strip, or implanted device.
- Age 18 years or older.
Who cannot join
- Previous typical CTI dependent right atrial flutter ablation
- Uncontrolled heart failure or NYHA function class 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 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 6 months
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- 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 6 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 catheter, as indicated in the respective Instructions For Use
About this study
Official title: Evaluation of a Multi-Electrode Linear Type Ablation Catheter for Endocardial Ablation of Patients With Right Atrial Flutter
The Linear II study is a prospective, single center, non-randomized, interventional feasibility study with the purpose of assessing acute safety of the Multi-Electrode Linear Type Ablation Catheter and the performance of the product when used for the treatment of symptomatic CTI (cavotricuspid isthmus) dependent right atrial flutter.
- Being tested
- Endocardial Ablation
- Keywords
- Endocardial Ablation, Atrial Flutter, Cavotricuspid Isthmus
- Medical subject headings
- Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endocardial AblationProcedure or surgery
Also called Radiofrequency (RF) ablation with the, - Linear Type Ablation Catheter, - nMARQ™ Multi-Channel RF Generator with Software V2.4.0, - Linear Ablation Connection Cable
| Study group | Role | What they receive |
|---|---|---|
| Endocardial Ablation | Experimental | Not described Receives: Procedure: Endocardial Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Incidence of early onset (within 7 days of ablation procedure) primary AEs
Measured: 7 Days
Acute performance
Acute procedural success as confirmed complete bidirectional conduction block across the CTI (assess ≥30 min following last RF application)
Measured: This outcome measure will be assessed during the procedure but after 30 minutes (or more) of the initial ablation
Secondary outcomes (3)
Safety
Incidence of Serious Adverse Events during follow-up
Measured: Until one-month follow-up
Acute Efficacy
Right atrial flutter recurrence within 30 days
Measured: Within 30 Days
Procedural data
Ablation parameters, including:
- Total RF ablation time
- Temperature
- Contact Force Procedural time Total fluoroscopy time
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 posted6 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionNov 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cavotricuspid Isthmus Dependent Right Atrial FlutterStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosense Webster, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Massimo Grimaldi, Principal investigator, Miulli Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02257060
- Sponsor's protocol ID
- LINEAR II
- Status last verified
- Jan 2025
- First submitted
- 2 Sep 2014
- Last updated
- 3 Feb 2025
- Results posted
- 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 Ablation Catheter for Endocardial Ablation of Patients With Right Atrial Flutter
- ClinicalTrials.gov ID
- NCT02257060
- Acronym / sponsor ID
- LINEAR II
- Keywords
- Endocardial Ablation, Atrial Flutter, Cavotricuspid Isthmus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Biosense Webster, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 6 Oct 2014 (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 Linear II study is a prospective, single center, non-randomized, interventional feasibility study with the purpose of assessing acute safety of the Multi-Electrode Linear Type Ablation Catheter and the performance of the product when used for the treatment of symptomatic CTI (cavotricuspid isthmus) dependent right atrial flutter.
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 | Experimental | Procedure: Endocardial Ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least one symptomatic episode of typical CTI dependent right atrial flutter documented by 12 lead ECG, Holter monitor, transtelephonic event monitor, telemetry strip, or implanted device.
- Age 18 years or older.
Key exclusion criteria (18 listed)
- Previous typical CTI dependent right atrial flutter ablation
- Uncontrolled heart failure or NYHA function class 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 procedure (ie, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
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 AblationAlso: Radiofrequency (RF) ablation with the, - Linear Type Ablation Catheter, - nMARQ™ Multi-Channel RF Generator with Software V2.4.0, - Linear Ablation Connection Cable | Procedure or surgery | Endocardial Ablation |
Primary outcome
Safety
Time frame: 7 Days
Incidence of early onset (within 7 days of ablation procedure) primary AEs
Acute performance
Time frame: This outcome measure will be assessed during the procedure but after 30 minutes (or more) of the initial ablation
Acute procedural success as confirmed complete bidirectional conduction block across the CTI (assess ≥30 min following last RF application)
3 secondary outcomes
Safety
Time frame: Until one-month follow-up
Acute Efficacy
Time frame: Within 30 Days
Procedural data
Time frame: During 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.
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.
Massimo Grimaldi principal investigator
Miulli Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Endocardial Ablation in people with Cavotricuspid Isthmus Dependent Right Atrial Flutter, 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 2 inclusion and 18 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Safety (time frame: 7 Days). 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 3 Feb 2025.