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

Phase 2

Terminated

• Conditions: LV Microcable; LV Lead; LV Therapy; LV Treatment

• Registration Number: NCT01731210
• Lead Sponsor: LivaNova

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-31
• Study First Submitted: 2012-11-15
• Study First Submitted QC: 2012-11-15
• Study First Posted: 2012-11-21
• Study Completion: 2013-12-19
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-12
• Last Update Posted: 2018-03-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Freedom from left ventricular lead related complications through 1 month	1 month

Trial Locations

Locations (1)

CHU Charles Nicolle; 🇫🇷 Rouen, France