Cardiac Resynchronization TherapyPOLARNCT01515761
POsition of Leads in Advanced heaRt Failure: the POLAR Study
A study testing Postero-lateral and Antero-Lateral in people with Cardiac Resynchronization Therapy and Heart Failure, run by Sergio Thal, M.D. at 2 sites in United States.
Trial summary
The primary objective is to determine if lead positioning in the lateral wall of the left ventricle in patients meeting criteria for cardiac resynchronization therapy plays a role in determining myocardial function and affects the severity of mitral regurgitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Resynchronization Therapy, Heart Failure
- What is being tested?
- Postero-lateral and Antero-Lateral
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2010to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject meets the general indications for an implantable cardioverter defibrillator (ICD) with LV systolic function ≤ 35% as defined by echocardiography.
- 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.
- Subject has a 12-lead electrocardiogram (ECG) obtained no more than 90 days prior to enrollment documenting a sinus rate > 50 bpm and PR interval < 320 ms measured from any two leads.
- 12 lead ECG with left bundle brunch block morphology and a QRS duration of at least 120 msec.
- Subject has creatinine < 2.5 mg/dL obtained no more than 30 days prior to enrollment.
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- Subject has left ventricular ejection fraction < 35% by echocardiogram no more than 1 year prior to enrollment.
- Subject is willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation.
- Subject has a life expectancy of more than 180 days, per physician discretion.
- Subject is age 18 or above, or of legal age to give informed consent specific to state and national law.
Who cannot join
- Subject has right bundle branch block morphology on a 12-lead ECG obtained no more than 90 days prior to enrollment.
- 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.
- Subject has an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) or persistent (i.e., can be terminated with medical intervention, but does not terminate spontaneously) within 30 days prior to enrollment.
- Subject currently requires dialysis.
- Subject has severe chronic obstructive pulmonary disease (COPD), defined as FEV1/FVC < 60%, or as defined by a physician.
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- Subject has had a myocardial infarction within 30 days prior to enrollment or coronary artery disease (CAD) in which surgical or percutaneous correction was performed within 30 days prior to enrollment.
- Subject has hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis).
- Subject is on IV inotropic agents.
- Subject has any mitral valve prosthesis, or a mechanical aortic or tricuspid prosthesis
- Subject is enrolled in any concurrent study, without Medtronic written approval, which may confound the results of this study.
- Subject is pregnant or planning to get pregnant.
- Subject requires oxygen for medical reasons other than CHF.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Lexington VA Medical Center
Lexington, Kentucky, 40502
Samy Elayi, M.D., 859-233-4511
Samy Elayi, M.D.
- Recruiting
Southern Arizona VA Health Care System
Tucson, Arizona, 85723
Sergio Thal, M.D., 520-792-1450 ext. 4624, sergio.thal@va.gov
Elizabeth Juneman, M.D., 520-792-1450 ext. 4624, elizabeth.juneman@va.gov
About this study
Official title: POsition of Leads in Advanced heaRt Failure: the POLAR Study - A 6 Month, Observational, Mult-centered, Blinded, Randomized Study to Determine if Lead Positioning in the Lateral Wall of LV in Patients Meeting Criteria for CRT Plays a Role in Determining Myocardial Function and Affect the Severity of Mitral Regurgitation
The primary objective is to determine if lead positioning in the lateral wall of the left ventricle in patients meeting criteria for cardiac resynchronization therapy plays a role in determining myocardial function and affects the severity of mitral regurgitation.
Read the detailed description
This is a 6 month, multi-centered, blinded, randomized study. Approximately 60 patients will join this study. Two groups, based on lead position, will be studied with thirty (30) patients randomized into each group.
- Conditions
- Cardiac Resynchronization Therapy, Heart Failure
- Being tested
- Postero-lateral, Antero-Lateral
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postero-lateralProcedure or surgery
A device implant procedure will be performed under the standard of care technique with the right ventricular lead at the right ventricular apex and the left ventricular lead targeting or postero-lateral area of the LV based on pre-procedure randomization.
Antero-LateralProcedure or surgery
A device implant procedure will be performed under the standard of care technique with the right ventricular lead at the right ventricular apex and the left ventricular lead targeting or antero-lateral area of the LV based on pre-procedure randomization.
| Study group | Role | What they receive |
|---|---|---|
| Postero-lateral | Active comparator | Left ventricular lateral wall lead position Receives: Procedure: Postero-lateral |
| Antero-lateral | Active comparator | Left ventricular lateral wall lead position Receives: Procedure: Antero-Lateral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change (reduction) in left ventricular end systolic volume (LVESV)
Measured: 3 and 6 months
Change in 6 minute walk tests
Measured: 6 weeks, 3 and 6 months
Secondary outcomes (5)
Myocardial performance as measured by myocardial performance index (MPI)
Measured: 6 months
Papillary muscle velocity as determined by tissue doppler
Measured: 6 months
Progression of mitral regurgitation
as measured by regurgitant volume, mitral regurgitation fraction and effective regurgitant orifice area
Measured: 6 months
Minnesota living heart failure survey
Measured: 6 weeks, 3 and 6 months
Chronic heart failure hospitalizations
Measured: Monitored during study participation ~ 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startSep 2010
- Primary completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Resynchronization TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sergio Thal, M.D.
- Sponsor type
- US federal agency
- Collaborators
- Medtronic, Lexington VA Medical Center
- Responsible party
- Sponsor-investigator, Sergio Thal, M.D., Southern Arizona VA Health Care System
- Investigators
- Sergio Thal, M.D., Principal investigator, Southern Arizona VA Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01515761
- Sponsor's protocol ID
- PIIT1A
- Acronym
- POLAR
- Status last verified
- Jan 2012
- First submitted
- 12 Jan 2012
- Last updated
- 24 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POsition of Leads in Advanced heaRt Failure: the POLAR Study - A 6 Month, Observational, Mult-centered, Blinded, Randomized Study to Determine if Lead Positioning in the Lateral Wall of LV in Patients Meeting Criteria for CRT Plays a Role in Determining Myocardial Function and Affect the Severity of Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT01515761
- Acronym / sponsor ID
- POLAR / PIIT1A
- Conditions
- Cardiac Resynchronization Therapy, Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sergio Thal, M.D.US federal agency
- Collaborators
- Medtronic, Lexington VA Medical Center
- Study start
- Sep 2010
- Primary completion
- Mar 2013 (estimated)
- First posted
- 24 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to determine if lead positioning in the lateral wall of the left ventricle in patients meeting criteria for cardiac resynchronization therapy plays a role in determining myocardial function and affects the severity of mitral regurgitation.
Detailed description
This is a 6 month, multi-centered, blinded, randomized study. Approximately 60 patients will join this study. Two groups, based on lead position, will be studied with thirty (30) patients randomized into each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postero-lateral | Active comparator | Procedure: Postero-lateralLeft ventricular lateral wall lead position |
| Antero-lateral | Active comparator | Procedure: Antero-LateralLeft ventricular lateral wall lead position |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject meets the general indications for an implantable cardioverter defibrillator (ICD) with LV systolic function ≤ 35% as defined by echocardiography.
- 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.
- Subject has a 12-lead electrocardiogram (ECG) obtained no more than 90 days prior to enrollment documenting a sinus rate > 50 bpm and PR interval < 320 ms measured from any two leads.
- 12 lead ECG with left bundle brunch block morphology and a QRS duration of at least 120 msec.
Key exclusion criteria (13 listed)
- Subject has right bundle branch block morphology on a 12-lead ECG obtained no more than 90 days prior to enrollment.
- 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.
- Subject has an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) or persistent (i.e., can be terminated with medical intervention, but does not terminate spontaneously) within 30 days prior to enrollment.
- Subject currently requires dialysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postero-lateralA device implant procedure will be performed under the standard of care technique with the right ventricular lead at the right ventricular apex and the left ventricular lead targeting or postero-lateral area of the LV based on pre-procedure randomization. | Procedure or surgery | Postero-lateral |
| Antero-LateralA device implant procedure will be performed under the standard of care technique with the right ventricular lead at the right ventricular apex and the left ventricular lead targeting or antero-lateral area of the LV based on pre-procedure randomization. | Procedure or surgery | Antero-lateral |
Primary outcome
Change (reduction) in left ventricular end systolic volume (LVESV)
Time frame: 3 and 6 months
Change in 6 minute walk tests
Time frame: 6 weeks, 3 and 6 months
5 secondary outcomes
Myocardial performance as measured by myocardial performance index (MPI)
Time frame: 6 months
Papillary muscle velocity as determined by tissue doppler
Time frame: 6 months
Progression of mitral regurgitation
Time frame: 6 months
Minnesota living heart failure survey
Time frame: 6 weeks, 3 and 6 months
Chronic heart failure hospitalizations
Time frame: Monitored during study participation ~ 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergio Thal, M.D. principal investigator
Southern Arizona VA Health Care System
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postero-lateral and Antero-Lateral in people with Cardiac Resynchronization Therapy and Heart Failure, run by Sergio Thal, M.D. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sergio Thal, M.D. (520-792-1450 ext. 4624, sergio.thal@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change (reduction) in left ventricular end systolic volume (LVESV) (time frame: 3 and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2012.