Model 4296 Left Ventricular (LV) Lead Study
This study has been completed.
Sponsor:
Medtronic Cardiac Rhythm Disease Management
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
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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
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 Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013