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

This study is currently recruiting participants.
Verified November 2012 by Sorin Group
Sponsor:
Information provided by (Responsible Party):
Sorin Group
ClinicalTrials.gov Identifier:
NCT01731210
First received: November 15, 2012
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

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 Intervention 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
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation Of The Nano Lv Lead System In Chronic Situation

Further study details as provided by Sorin Group:

Primary Outcome Measures:
  • Freedom from left ventricular lead related complications through 1 month [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 128
Study Start Date: November 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731210

Contacts
Contact: Frédéric Mr ANSELME, MD + 33 (0)2 32 88 86 25 frederic.anselme@chu-rouen.fr
Contact: Ghislaine Mrs GESTIN +33 1 46 01 36 06 ghislaine.gestin@sorin.com

Locations
France
CHU Charles Nicolle Recruiting
Rouen, France, 76000
Sponsors and Collaborators
Sorin Group
  More Information

No publications provided

Responsible Party: Sorin Group
ClinicalTrials.gov Identifier: NCT01731210     History of Changes
Other Study ID Numbers: LCNA02 - LENEA
Study First Received: November 15, 2012
Last Updated: November 20, 2012
Health Authority: France: National agency of health and medecine
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: ministery of health
Italy: ministery of health

ClinicalTrials.gov processed this record on April 17, 2014