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N/A N=90 Treatment

Model 4296 Left Ventricular (LV) Lead Study

Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT00927251 ↗
Enrolled (actual)
90
Serious AEs
17.8%
Results posted
Dec 2010
Primary outcome: Primary: Number of Participants With Left Ventricular (LV)Lead Related Complications — 1 participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Pacing Lead (Model 4296 LV Lead) (Device)
Age
Pediatric, Adult, Older Adult
Sex
All
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Primary completion
Dec 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Left Ventricular (LV)Lead Related Complications		 1 —

Summary

This study is designed to show that a new lead, which paces the left bottom chamber (left ventricle) of the heart, is safe. Using a lead on the left side of the heart has been shown to potentially improve heart failure symptoms. The shape and size of this new lead may make it a good choice for patients or physicians.

Eligibility Criteria

Inclusion Criteria

  • Cardiac Resynchronization Therapy (CRT)/Cardiac Resynchronization Therapy-Defibrillator (CRT-D) indications according to the European Society of Cardiology/American College of Cardiology/American Heart Association (ESC/ACC/AHA) guidelines
  • On optimal medical treatment according to investigator opinion
  • Indicated for implantable cardioverter defibrillator (ICD) if CRT-D is implanted
  • Patient consent
  • Geographically stable

Exclusion Criteria

  • Left Ventricular (LV) lead implant attempt in last 30 days
  • Unstable angina or acute myocardial infarction (MI) in past 30 days
  • Coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) in past 90 days
  • Contraindicated for transvenous pacing
  • Heart transplant
  • Contraindicated for less than 1 milligram (mg) dexamethasone acetate
  • Enrolled or intends to participate in concurrent drug and/or device study which would confound results
  • Life expectancy shorter than duration of the study
  • Exclusion criteria required by local law
  • Unable to tolerate urgent thoracotomy
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00927251). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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