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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014