Model 20066 Left Ventricular (LV) Lead Study - Full Text View

Purpose

Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed. CRT is similar to a pacemaker. It is placed (implanted) under the skin of the upper chest. CRT is delivered as tiny electrical pulses to the right and left ventricles through three leads (flexible insulated wires) that are inserted through the veins to the heart. The purpose of this study is to evaluate a new lead for delivering energy to the left ventricle (bottom left chamber of the heart).

Condition	Intervention	Phase
Heart Failure	Device: Pacing Lead	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Model 20066 Left Ventricular (LV) Lead Study

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

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

Primary Outcome Measures:

Number of implant procedure related and lead-related complications in the first month post-implant [ Time Frame: One Month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Success rate of the Model 20066 lead [ Time Frame: Within 24 hours of procedure initiation ] [ Designated as safety issue: No ]
Cannulation time [ Time Frame: Within 24 hours of procedure initiation ] [ Designated as safety issue: No ]
Fluoroscopy Time [ Time Frame: Within 24 hours of procedure initiation ] [ Designated as safety issue: No ]
Model 20066 Lead Placement Time [ Time Frame: Within 24 hours of procedure initiation ] [ Designated as safety issue: No ]
Total Implant Time [ Time Frame: Within 24 hours of procedure initiation ] [ Designated as safety issue: No ]
Assessment of Lead Handling Characteristics [ Time Frame: Within 24 hours of procedure initiation ] [ Designated as safety issue: No ]
Electrical Performance-Tip Electrode: LV Voltage Threshold [ Time Frame: 12-month ] [ Designated as safety issue: No ]
Electrical Performance -Tip Electrode: Sensing [ Time Frame: 12-month ] [ Designated as safety issue: No ]
Electrical Performance -Tip Electrode: Pacing Impedance [ Time Frame: 12-month ] [ Designated as safety issue: No ]
Electrical Performance -Ring Electrode: LV Voltage Threshold [ Time Frame: 12-month ] [ Designated as safety issue: No ]
Electrical Performance -Ring Electrode: Sensing [ Time Frame: Within 24 hours of procedure initiation ] [ Designated as safety issue: No ]
Electrical Performance -Ring Electrode: Pacing Impedance [ Time Frame: 12-month ] [ Designated as safety issue: No ]
Summarize All Adverse Events [ Time Frame: 12-month ] [ Designated as safety issue: No ]
Summarize Final 20066 Lead Position [ Time Frame: Within 24 hours of procedure initiation ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	July 2011
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 20066 Lead Non-randomized study. Intervention: Device: Pacing Lead	Device: Pacing Lead Implant and follow up of Model 20066 lead

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient meets CRT inclusion criteria as determined by local regulatory and/or hospital policy
Patient has signed and dated the study-specific informed consent form
Patient is 18 years of age or older
Patient is expected to remain available for follow-ups at the investigational center
Patient is willing and able to comply with protocol

Exclusion Criteria:

Patient has a previous complete atrial based biventricular CRT system
Patient has a previous LV lead implanted or previous implant attempt within 30 days of implant or ongoing AEs from previous unsuccessful attempt
Patient has known coronary venous vasculature that is inadequate for lead placement
Patient has unstable angina pectoris or has had an acute myocardial infarction (MI) within the past month
Patient has had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past three months
Patient has chronic (permanent) atrial arrhythmias
Patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right heart valve)
Patient has had a heart transplant (patients waiting for heart transplants are allowed in the study)
Patient is enrolled in any concurrent drug and/or device study that may confound the results of this study
Patient has a terminal illness and is not expected to survive more than three months
Patient meets exclusion criteria required by local law (e.g. age, incompetence, pregnancy, breast feeding, etc).
Patient is unable to tolerate an urgent thoracotomy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01365234

Locations

Canada

London, Canada

Newmarket, Canada
Malaysia

Kuala Lumpur, Malaysia
Sweden

Stockholm, Sweden

Sponsors and Collaborators

Medtronic Cardiac Rhythm Disease Management

Investigators

Principal Investigator:

Raymond Yee, MD

London Health Sciences Centre, London, Ontario, Canada

More Information

No publications provided

Responsible Party:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT01365234 History of Changes
Other Study ID Numbers:	Model 20066
Study First Received:	May 25, 2011
Last Updated:	December 3, 2012
Health Authority:	Canada: Health Canada Sweden: Regional Ethical Review Board Malaysia: Ministry of Health

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013