NCT01731210TerminatedPhase 2
Clinical Evaluation Of The Nano Lv Lead System In Chronic Situation
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- LivaNova
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Freedom from left ventricular lead related complications through 1 month
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Freedom from left ventricular lead related complications through 1 month
Time Frame: 1 month
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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