Model 4296 Left Ventricular (LV) Lead Study

This study has been completed.
Sponsor:
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00927251
First received: June 23, 2009
Last updated: December 1, 2010
Last verified: June 2010
  Purpose

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 Intervention Phase
Heart Failure
Device: Pacing Lead (Model 4296 LV Lead)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Model 4296 Left Ventricular Lead Study

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Number of Participants With Left Ventricular (LV)Lead Related Complications [ Time Frame: Implant to one-month post implant ] [ Designated as safety issue: No ]
    A LV lead related complication occurs when an invasive procedure is needed to correct an adverse event related to the LV lead.


Enrollment: 90
Study Start Date: June 2009
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Model 4296 LV Lead
Non-randomized study
Device: Pacing Lead (Model 4296 LV Lead)
Implant and follow-up of study device

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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927251

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
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Principal Investigator: M. Biffi, M.D. Policlinico S. Orsola-Malpighi in Bologna, Italy
  More Information

No publications provided

Responsible Party: Model 4296 Left Ventricular (LV) Lead Clinical Trial Leader, Medtronic, Inc.
ClinicalTrials.gov Identifier: NCT00927251     History of Changes
Other Study ID Numbers: 4296
Study First Received: June 23, 2009
Results First Received: June 7, 2010
Last Updated: December 1, 2010
Health Authority: Austria: Agency for Health and Food Safety
Finland: Finnish Medicines Agency
Germany: Bezirksregierung Düsseldorf
India: Central Drugs Standard Control Organization
India: Ministry of Health
Italy: Ministry of Health
Netherlands: Ministry of Health, Welfare and Sport
Norway: Directorate of Health
Slovakia: State Institute for Drug Control

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
heart failure
cardiac pacing
cardiac resynchronization therapy
left ventricular lead

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 21, 2014