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Pacing Lead

Phase 1

Heart Failure | Unknown | Cardiovascular |Medtronic plc.|Last Updated: Oct 12, 2016

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Pacing Lead · 1 trial · 1 indication

Phase 1 1
NCT01365234Model 20066 Left Ventricular (LV) Lead StudyHeart Failure
COMPLETED40 Analytics
PHASE1COMPLETED
Model 20066 Left Ventricular (LV) Lead Study
Heart FailureUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of implant procedure related and lead-related complications in the first month post-implant
One Month

Secondary Endpoints

Success rate of the Model 20066 lead
Within 24 hours of procedure initiation
Cannulation time
Within 24 hours of procedure initiation
Fluoroscopy Time
Within 24 hours of procedure initiation
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
20066 LeadEXPERIMENTALNon-randomized study. Intervention: Device: Pacing Lead

Interventions

NameTypeDescription
Pacing LeadDEVICEImplant and follow up of Model 20066 lead
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

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 investiga...

Countries:CanadaMalaysiaSweden
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Frequently asked questions about Pacing Lead

What is Pacing Lead used for in Heart Failure?

Pacing Lead is an investigational medical device being studied for use in Heart Failure. It is a left ventricular lead, model 20066, intended to deliver pacing therapy to the heart. The device is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes Pacing Lead?

Pacing Lead is developed by Medtronic plc, a medical technology company traded on the New York Stock Exchange under the ticker MDT. The company is conducting clinical research to evaluate the safety and performance of this left ventricular lead for heart failure patients.

What phase is Pacing Lead in?

Pacing Lead is in Phase 1 clinical development. It is an investigational device, meaning it has not yet received regulatory approval and is still being studied in clinical trials. The Phase 1 study has been completed, and the device remains under evaluation for heart failure.

What clinical trials is Pacing Lead in?

Pacing Lead has one completed clinical trial, identified as NCT01365234, titled 'Model 20066 Left Ventricular (LV) Lead Study'. This Phase 1 study enrolled 40 participants with heart failure across Canada, Malaysia, and Sweden. The trial was uncontrolled and not randomized or double-blinded.

Is Pacing Lead FDA approved?

Pacing Lead is not FDA approved. It is an investigational device currently in Phase 1 clinical development for heart failure. The completed clinical trial, NCT01365234, was a Phase 1 study, and the device has not yet received marketing authorization from regulatory agencies.