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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Pacing Lead (Model 4296 LV Lead)
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring heart failure, cardiac pacing, cardiac resynchronization therapy, left ventricular lead

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Model 4296 LV Lead

Arm Description

Non-randomized study

Outcomes

Primary Outcome Measures

Number of Participants With Left Ventricular (LV)Lead Related Complications
A LV lead related complication occurs when an invasive procedure is needed to correct an adverse event related to the LV lead.

Secondary Outcome Measures

Full Information

First Posted
June 23, 2009
Last Updated
January 31, 2019
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT00927251
Brief Title
Model 4296 Left Ventricular (LV) Lead Study
Acronym
4296
Official Title
Model 4296 Left Ventricular Lead Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, cardiac pacing, cardiac resynchronization therapy, left ventricular lead

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Model 4296 LV Lead
Arm Type
Experimental
Arm Description
Non-randomized study
Intervention Type
Device
Intervention Name(s)
Pacing Lead (Model 4296 LV Lead)
Intervention Description
Implant and follow-up of study device
Primary Outcome Measure Information:
Title
Number of Participants With Left Ventricular (LV)Lead Related Complications
Description
A LV lead related complication occurs when an invasive procedure is needed to correct an adverse event related to the LV lead.
Time Frame
Implant to one-month post implant

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Biffi, M.D.
Organizational Affiliation
Policlinico S. Orsola-Malpighi in Bologna, Italy
Official's Role
Principal Investigator
Facility Information:
City
Linz
Country
Austria
City
Wien
Country
Austria
City
Oulu
Country
Finland
City
Bad Rothenfelde
Country
Germany
City
Essen
Country
Germany
City
Heidelberg
Country
Germany
City
Luedenscheid
Country
Germany
City
Ulm
Country
Germany
City
Delhi
Country
India
City
Bologna
Country
Italy
City
Pesaro
Country
Italy
City
Rovigo
Country
Italy
City
Breda
Country
Netherlands
City
Eindhoven
Country
Netherlands
City
Bergen
Country
Norway
City
Kosice
Country
Slovakia

12. IPD Sharing Statement

Learn more about this trial

Model 4296 Left Ventricular (LV) Lead Study

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