CompletedPhase 1

LINEAR II - LME-159 Evaluation of a Multi-Electrode Linear Type Ablation Catheter

12 participantsStarted 2014-09

Plain-language 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 atrial flutter.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 * 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 clinic…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety

Timeframe: 7 Days

Acute performance

Timeframe: This outcome measure will be assessed during the procedure but after 30 minutes (or more) of the initial ablation

Trial details

NCT IDNCT02257060

SponsorBiosense Webster, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-11

View on ClinicalTrials.gov More Cavotricuspid Isthmus Dependent Right Atrial Flutter trials