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Procedure

Lead Placement for Cardiac Resynchronization in Heart Failure (POLAR Trial)

N/A
Waitlist Available
Research Sponsored by Sergio Thal, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation
Be older than 18 years old
Must not have
Subject had previous cardiac resynchronization therapy, a previous coronary venous lead, or meets the general indications for anti-bradycardia pacing defined as ventricular pacing > 40% by pacemaker interrogation
Subject has a neuromuscular, orthopedic, or other non-cardiac condition that prevents normal, unsupported walking
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether or not placing a lead in the lateral wall of the left ventricle in patients who need cardiac resynchronization therapy affects myocardial function and the severity of mitral regurgitation.

Who is the study for?
This trial is for adults with severe heart failure (NYHA Class III-IV) who've been stable on heart failure medication for at least 30 days, have a left ventricular ejection fraction ≤ 35%, and meet criteria for an implantable defibrillator. They should not be pregnant, involved in other studies that affect results, or have conditions like hypertrophic cardiomyopathy or need dialysis.
What is being tested?
The POLAR Study is testing whether the position of leads on the left ventricle's lateral wall during cardiac resynchronization therapy affects heart muscle function and mitral regurgitation severity in patients with advanced heart failure.
What are the potential side effects?
While specific side effects are not listed here, generally, procedures involving lead placement can include risks such as bleeding, infection at the site of device implantation, dislodgement of leads, and potential worsening of heart failure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing and able to have a device implanted for this study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had heart rhythm treatment or need a pacemaker due to slow heartbeats.
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I cannot walk normally without support due to a condition not related to my heart.
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I have a type of irregular heartbeat that doesn't stop on its own or needs treatment to stop.
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I am currently on dialysis.
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I have severe COPD as confirmed by my doctor.
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I had a heart attack or heart surgery within the last 30 days.
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I have a type of heart disease that causes thickening or abnormal buildup in the heart.
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I am currently receiving IV medication to strengthen my heart.
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I need oxygen for a medical condition not related to heart failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Progression of mitral regurgitation

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Postero-lateralActive Control1 Intervention
Left ventricular lateral wall lead position
Group II: Antero-lateralActive Control1 Intervention
Left ventricular lateral wall lead position

Find a Location

Who is running the clinical trial?

MedtronicIndustry Sponsor
619 Previous Clinical Trials
764,028 Total Patients Enrolled
92 Trials studying Heart Failure
91,911 Patients Enrolled for Heart Failure
Lexington VA Medical CenterFED
Sergio Thal, M.D.Lead Sponsor

Media Library

Antero-Lateral (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT01515761 — N/A
Heart Failure Research Study Groups: Postero-lateral, Antero-lateral
Heart Failure Clinical Trial 2023: Antero-Lateral Highlights & Side Effects. Trial Name: NCT01515761 — N/A
Antero-Lateral (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01515761 — N/A
~4 spots leftby Dec 2025
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