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

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ClinicalTrials.gov Identifier: NCT01731210
Recruitment Status : Terminated (Study stopped due to investigational device deficiency)
First Posted : November 21, 2012
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
LV Lead LV Therapy LV Treatment LV Microcable Device: implantation of the new LV lead: NANO system. Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Intervention Model Description: NANO LV lead
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation Of The Nano Lv Lead System In Chronic Situation
Actual Study Start Date : October 31, 2012
Actual Study Completion Date : December 19, 2013



Primary Outcome Measures :
  1. Freedom from left ventricular lead related complications through 1 month [ Time Frame: 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01731210


Locations
France
CHU Charles Nicolle
Rouen, France, 76000
Sponsors and Collaborators
LivaNova

Responsible Party: LivaNova
ClinicalTrials.gov Identifier: NCT01731210     History of Changes
Other Study ID Numbers: LCNA02 - LENEA
First Posted: November 21, 2012    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018