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

January 31, 2019 updated by: Medtronic Cardiac Rhythm and Heart Failure

Model 4296 Left Ventricular Lead Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Implant to one-month post implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Investigators

  • Principal Investigator: M. Biffi, M.D., Policlinico S. Orsola-Malpighi in Bologna, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

June 23, 2009

First Submitted That Met QC Criteria

June 23, 2009

First Posted (Estimate)

June 24, 2009

Study Record Updates

Last Update Posted (Actual)

February 18, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4296

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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