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

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: LV Lead; LV Therapy; LV Treatment; LV Microcable
• Intervention / Treatment: Device: implantation of the new LV lead: NANO system.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

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

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	1 month

Collaborators and Investigators

• Sponsor: LivaNova

Study record dates

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