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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 has moderate or severe heart failure, defined as NYHA Class III-IV for at least 90 days prior to enrollment
Subject has optimal pharmacological heart failure therapy for at least 30 days prior to enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks, 3 and 6 months
Awards & highlights

POLAR Trial 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.Check my eligibility
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.See study design
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.

POLAR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had serious heart failure (Class III-IV) for at least 3 months.
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I have been on heart failure medication for at least 30 days.
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My recent ECG shows a heart rate over 50 bpm and a normal PR interval.
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My heart's pumping ability is below 35% as shown in a recent heart scan.
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I am willing and able to have a device implanted for this study.
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My creatinine level is below 2.5 mg/dL, tested within the last 30 days.
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I am at least 18 years old or of legal age to consent where I live.

POLAR Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change (reduction) in left ventricular end systolic volume (LVESV)
Change in 6 minute walk tests
Secondary outcome measures
Chronic heart failure hospitalizations
Minnesota living heart failure survey
Myocardial performance as measured by myocardial performance index (MPI)
+2 more

POLAR 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
605 Previous Clinical Trials
828,251 Total Patients Enrolled
90 Trials studying Heart Failure
90,789 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any participants being enrolled in this experiment at the present time?

"Clinicaltrials.gov confirms that this investigation, which was initially posted on the 1st of September 2010 and later revised on 23rd January 2012, is not currently looking for participants. Nonetheless, there are 702 other medical trials accepting enrolment at present."

Answered by AI
~4 spots leftby Mar 2025