NCT00927251

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Jun 2009

Shorter than P25 for not_applicable heart-failure

Geographic Reach
8 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 24, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
11 months until next milestone

Results Posted

Study results publicly available

December 29, 2010

Completed
Last Updated

February 18, 2019

Status Verified

January 1, 2019

Enrollment Period

6 months

First QC Date

June 23, 2009

Results QC Date

June 7, 2010

Last Update Submit

January 31, 2019

Conditions

Heart Failure

Keywords

heart failurecardiac pacingcardiac resynchronization therapyleft ventricular lead

Outcome Measures

Primary Outcomes (1)

  • 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.

    Implant to one-month post implant

Study Arms (1)

Model 4296 LV Lead

EXPERIMENTAL

Non-randomized study

Device: Pacing Lead (Model 4296 LV Lead)

Interventions

Pacing Lead (Model 4296 LV Lead)DEVICE

Implant and follow-up of study device

Model 4296 LV Lead

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Unable to tolerate urgent thoracotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Unknown Facility

Linz, Austria

Location

Unknown Facility

Vienna, Austria

Location

Unknown Facility

Oulu, Finland

Location

Unknown Facility

Bad Rothenfelde, Germany

Location

Unknown Facility

Essen, Germany

Location

Unknown Facility

Heidelberg, Germany

Location

Unknown Facility

Lüdenscheid, Germany

Location

Unknown Facility

Ulm, Germany

Location

Unknown Facility

Delhi, India

Location

Unknown Facility

Bologna, Italy

Location

Unknown Facility

Pesaro, Italy

Location

Unknown Facility

Rovigo, Italy

Location

Unknown Facility

Breda, Netherlands

Location

Unknown Facility

Eindhoven, Netherlands

Location

Unknown Facility

Bergen, Norway

Location

Unknown Facility

Košice, Slovakia

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Model 4296 Left Ventricular (LV) Lead Study Sr. CRS
Organization
Medtronic, Bakken Research Center
margriet.kruijshoop@medtronic.com
+31-43-3566602

Study Officials

  • M. Biffi, M.D.

    Policlinico S. Orsola-Malpighi in Bologna, Italy

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2009

First Posted

June 24, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2009

Study Completion

February 1, 2010

Last Updated

February 18, 2019

Results First Posted

December 29, 2010

Record last verified: 2019-01

Locations

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