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

LV Lead Clinical Trial

— LENEA  

Official title:

Clinical Evaluation Of The Nano Lv Lead System In Chronic Situation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01731210
• Other study ID #: LCNA02 - LENEA
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: November 15, 2012
• Last updated: March 12, 2018
• Start date: October 31, 2012
• Est. completion date: December 19, 2013

Study information

• Verified date: March 2018
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: December 19, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• LV Lead
• LV Microcable
• LV Therapy
• LV Treatment

Intervention

Device:
• implantation of the new LV lead: NANO system.

Locations

Country	Name	City	State
France	CHU Charles Nicolle	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
LivaNova

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from left ventricular lead related complications through 1 month		1 month