Model 4296 Left Ventricular (LV) Lead Study

Heart Failure Clinical Trial

— 4296  

Official title:

Model 4296 Left Ventricular Lead Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00927251
• Other study ID #: 4296
• Status: Completed
• Phase: N/A
• Start date: June 2009
• Est. completion date: February 2010

Study information

• Verified date: January 2019
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Pacing Lead (Model 4296 LV Lead)
Implant and follow-up of study device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

Austria,  Finland,  Germany,  India,  Italy,  Netherlands,  Norway,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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