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Clinical Trials/NCT02257060
NCT02257060CompletedPhase 1

Evaluation of a Multi-Electrode Linear Type Ablation Catheter for Endocardial Ablation of Patients With Right Atrial Flutter

Biosense Webster, Inc.0 sites12 target enrollmentStarted: September 1, 2014Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
12
Primary Endpoint
Safety
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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 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

Arms & Interventions

Endocardial Ablation

Experimental

Intervention: Endocardial Ablation (Procedure)

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • Safety(Until one-month follow-up)
  • Acute Efficacy(Within 30 Days)
  • Procedural data(During Procedure)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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