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Model 4296 Left Ventricular (LV) Lead Study (4296)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00927251
Recruitment Status : Completed
First Posted : June 24, 2009
Results First Posted : December 29, 2010
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Pacing Lead (Model 4296 LV Lead) Not Applicable

Detailed Description:
This study is a prospective, multi-center, non-randomized design trial. All consented patients who meet all inclusion and no exclusion criteria may receive the investigational lead. The study design has statistical power to show safety at one-month after implant.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Model 4296 Left Ventricular Lead Study
Study Start Date : June 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Experimental: Model 4296 LV Lead
Non-randomized study
 Device: Pacing Lead (Model 4296 LV Lead)
Implant and follow-up of study device


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Left Ventricular (LV)Lead Related Complications [ Time Frame: Implant to one-month post implant ]
    A LV lead related complication occurs when an invasive procedure is needed to correct an adverse event related to the LV lead.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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): NCT00927251


Locations
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Austria
Linz, Austria
Wien, Austria
Finland
Oulu, Finland
Germany
Bad Rothenfelde, Germany
Essen, Germany
Heidelberg, Germany
Luedenscheid, Germany
Ulm, Germany
India
Delhi, India
Italy
Bologna, Italy
Pesaro, Italy
Rovigo, Italy
Netherlands
Breda, Netherlands
Eindhoven, Netherlands
Norway
Bergen, Norway
Slovakia
Kosice, Slovakia
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
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Principal Investigator: M. Biffi, M.D. Policlinico S. Orsola-Malpighi in Bologna, Italy
More Information
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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT00927251    
Other Study ID Numbers: 4296
First Posted: June 24, 2009    Key Record Dates
Results First Posted: December 29, 2010
Last Update Posted: February 18, 2019
Last Verified: January 2019
Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
heart failure
cardiac pacing
cardiac resynchronization therapy
left ventricular lead
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases