Model 20066 Left Ventricular (LV) Lead Study

Heart Failure Clinical Trial

Official title:

Model 20066 Left Ventricular (LV) Lead Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365234
• Other study ID #: Model 20066
• Status: Completed
• Phase: Phase 1
• First received: May 25, 2011
• Last updated: October 10, 2016
• Start date: July 2011
• Est. completion date: December 2015

Study information

• Verified date: October 2016
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaSweden: Regional Ethical Review BoardMalaysia: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Adverse Events 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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Pacing Lead
Implant and follow up of Model 20066 lead

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

Canada,  Malaysia,  Sweden, 

References & Publications (1)

Yee R, Gadler F, Hussin A, Bin Omar R, Khaykin Y, Verma A, Lazeroms M, Hine DS, Marquard KR. Novel active fixation mechanism permits precise placement of a left ventricular lead: early results from a multicenter clinical study. Heart Rhythm. 2014 Jul;11(7 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of implant procedure related and lead-related complications in the first month post-implant		One Month	No
Secondary	Success rate of the Model 20066 lead		Within 24 hours of procedure initiation	No
Secondary	Cannulation time		Within 24 hours of procedure initiation	No
Secondary	Fluoroscopy Time		Within 24 hours of procedure initiation	No
Secondary	Model 20066 Lead Placement Time		Within 24 hours of procedure initiation	No
Secondary	Total Implant Time		Within 24 hours of procedure initiation	No
Secondary	Assessment of Lead Handling Characteristics		Within 24 hours of procedure initiation	No
Secondary	Electrical Performance-Tip Electrode: LV Voltage Threshold		12-month	No
Secondary	Electrical Performance -Tip Electrode: Sensing		12-month	No
Secondary	Electrical Performance -Tip Electrode: Pacing Impedance		12-month	No
Secondary	Electrical Performance -Ring Electrode: LV Voltage Threshold		12-month	No
Secondary	Electrical Performance -Ring Electrode: Sensing		Within 24 hours of procedure initiation	No
Secondary	Electrical Performance -Ring Electrode: Pacing Impedance		12-month	No
Secondary	Summarize All Adverse Events		12-month	No
Secondary	Summarize Final 20066 Lead Position		Within 24 hours of procedure initiation	No