Clinical Evaluation Of The Nano Lv Lead System In Chronic Situation (LENEA) (LENEA)

March 12, 2018 updated by: LivaNova

Clinical Evaluation Of The Nano Lv Lead System In Chronic Situation

The LENEA study is an international, prospective, open label, non-randomized multicenter clinical research study designed to assess the safety and effectiveness of the NANO LV lead system.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France, 76000
        • CHU Charles Nicolle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D system for treatment of heart failure or life threatening ventricular tachyarrhythmia(s)
  • Receiving a new implant OR undergoing an upgrade from an existing ICD or pacemaker implant with no prior implanted LV lead OR undergoing a new LV implant attempt consecutive to a recent LV lead placement failure not related to coronary sinus cannulation failure
  • Patient receiving the PARADYM RF CRT or PARADYM RF CRT SONR devices
  • Ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion Criteria:

  • Ventricular tachyarrhythmia of transient or reversible causes such as acute myocardial infarction, digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia or sepsis, uncorrected at the time of the enrolment;
  • Incessant Ventricular tachyarrhythmias;
  • Unstable angina, or acute MI , CABG , or PTCA within the past 4 weeks;
  • Correctable valvular disease that is the primary cause of heart failure;
  • Post heart transplant (patients who are waiting for a heart transplant are allowed in the study);
  • Patient who had previously a permanently implanted LV lead;
  • Concurrent implant with another pacemaker or ICD (previously implanted pacemaker or ICD devices should be removed prior to implant with the Paradym RF CRT-D or Paradym RF CRT SONR);
  • Already included in another clinical study that could confound the results of this study;
  • Life expectancy less than 1 year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Freedom from left ventricular lead related complications through 1 month
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LivaNova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2012

Study Completion (Actual)

December 19, 2013

Study Registration Dates

First Submitted

November 15, 2012

First Submitted That Met QC Criteria

November 15, 2012

First Posted (Estimate)

November 21, 2012

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 12, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • LCNA02 - LENEA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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