Heart Failure, SystolicMETEOR-CRTNCT04083690
Multi-lead ECG to Effectively Optimize Resynchronization Devices: New CRT Recipients
A study testing Reprogramming of CRT Device Settings to Optimal Electrical Synchrony in people with Heart Failure, Systolic, run by Allina Health System at 2 sites in United States.
Trial summary
Cardiac resynchronization therapy (CRT), or atrial-synchronized biventricular (BiV) pacing, is an FDA-approved device therapy option for heart failure (HF) patients with reduced left ventricular ejection fraction and electrical dyssynchrony. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Heart Failure, Systolic
- What is being tested?
- Reprogramming of CRT Device Settings to Optimal Electrical Synchrony
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Oct 2019to 1 Oct 2024
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (or their legal guardian) must be willing to provide informed consent and sign a data privacy authorization (HIPAA) form
- Age greater than or equal 18 years
- Pre-CRT EF less than or equal 40%
- Patients will be receiving or have received a first-time CRT device for standard clinical indications within ~2 months of study enrollment
- Adequate echocardiographic images for LV EF and LV ESV determination
- On optimal medical therapy
Who cannot join
- Patients who are pregnant or may become pregnant
- Patient has a history of severe allergic reactions from ECG gel/ electrode adhesives
- Patient has a His Bundle pacing lead
- Patient has right bundle branch block (RBBB)
- Patient is enrolled in concurrent research study that would potentially confound the results of this study
- Premature ventricular contraction (PVC) burden greater than or equal to 10%
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Minneapolis Heart Institute (Abbott Northwestern Hospital)
Minneapolis, Minnesota, 55407
Peter M Eckman, MD, 612-863-9000, peter.eckman@allina.com
Christopher D Brown, 651-241-2806, christopher.brown2@allina.com
- Recruiting
United Heart & Vascular Clinic
Saint Paul, Minnesota, 55102
Christopher D Brown, BA, 651-241-2806, christopher.brown2@allina.com
Alan J Bank, MD
About this study
Cardiac resynchronization therapy (CRT), or atrial-synchronized biventricular (BiV) pacing, is an FDA-approved device therapy option for heart failure (HF) patients with reduced left ventricular ejection fraction and electrical dyssynchrony. A traditional CRT device has pacing leads implanted within the right atrium (RA), the right ventricle (RV), and within a coronary vein overlying the lateral or posterior left ventricle (LV). Within the past decade, various multi-center randomized controlled trials have reported improved quality of life, aerobic exercise capacity, LV systolic function and structure, as well as decreased hospitalization rates and mortality among patients with HF. Despite improvements in CRT technology with multipoint pacing, quadripolar leads, and adaptive pacing algorithms, approximately 30% of patients do not clinically benefit and are considered non-responders. This study looks to optimize new CRT device recipients using information obtained from standard ECG machines.
Read the detailed description
This is a prospective, randomized study designed to evaluate if CRT device optimization, guided by electrocardiography, improves echocardiographic and clinical outcomes among HF patients with a CRT device implanted for standard indications. All patients will have measurement of electrocardiograms at a range of device settings. Patients will be randomized in a 1:1 ratio to either the active comparator arm (standard CRT programming), or the experimental arm (CRT device programmed by the information obtained by ECGs). Standard CRT programming used in this study is simultaneous biventricular (BiV) pacing with a fixed atrioventricular delay. At 6 months, control patients who were initially randomized to standard programming will have programming changed based on the ECG optimization information. Patients will be blinded to randomization. Change of LV size and function will be performed prior to randomization, and again ~6 and ~12 months following CRT implant in both subgroups.
- Conditions
- Heart Failure, Systolic
- Being tested
- Reprogramming of CRT Device Settings to Optimal Electrical Synchrony
- Keywords
- Cardiac Resynchronization Therapy, Pacing, Echocardiography, Electrocardiography, Optimization, Heart Failure
- Medical subject headings
- Heart Failure, Systolic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reprogramming of CRT Device Settings to Optimal Electrical SynchronyDevice
Reprogramming of CRT device to maximize the benefit based on the ECG CRT optimization information.
| Study group | Role | What they receive |
|---|---|---|
| Standard CRT Programming, then ECG CRT Optimization | Active comparator | The control arm patients will have standard CRT programming for the first 6 months, and then will be reprogrammed based on the ECG CRT optimization information for the following 6 months Receives: Device: Reprogramming of CRT Device Settings to Optimal Electrical Synchrony |
| ECG CRT Optimization | Experimental | The experimental arm patients will have CRT device reprogrammed based on the ECG CRT optimization information for 12 months. Receives: Device: Reprogramming of CRT Device Settings to Optimal Electrical Synchrony |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in left ventricular size
Change in left ventricular end-systolic volume (LVESV), measured by echocardiogram, in patients in the experimental arm vs active comparator arm
Measured: 6 months
Secondary outcomes (4)
Change in left ventricular function
Change left ventricular ejection fraction (EF), measured by echocardiogram, in patients in the experimental arm vs active comparator arm
Measured: 6 months
Change in left ventricular size
Change in LVESV, measured by echocardiogram, in the subset of patients with left bundle branch block (LBBB) or intraventricular conduction delay (IVCD) in the experimental arm vs the active comparator arm
Measured: 6 months
Change in left ventricular size
Change in LVESV, measured by echocardiogram, in the subset of patients with complete heart block (CHB) or persistent atrial fibrillation (AF) in the experimental arm vs the active comparator arm
Measured: 6 months
Change in left ventricular size
Change in LVESV, measured by echocardiogram, in patients in the active comparator arm (crossed-over to optimization device settings at 6 months) at 12 months vs 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start11 Oct 2019
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, SystolicStudies 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
- Model description
- 1:1 randomization - active comparator and experimental arm (note: at 6 months the control arm will crossover)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allina Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alan J. Bank, MD, Allina Health System
- Investigators
- Alan J Bank, MD, Principal investigator, United Heart & Vascular - Allina Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083690
- Sponsor's protocol ID
- IRBnet#: 1455594
- Acronym
- METEOR-CRT
- Status last verified
- Jun 2022
- First submitted
- 30 Aug 2019
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We do not plan to share IPD with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-lead ECG to Effectively Optimize Resynchronization Devices: New CRT Recipients
- ClinicalTrials.gov ID
- NCT04083690
- Acronym / sponsor ID
- METEOR-CRT / IRBnet#: 1455594
- Conditions
- Heart Failure, Systolic
- Keywords
- Cardiac Resynchronization Therapy, Pacing, Echocardiography, Electrocardiography, Optimization, Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Allina Health SystemUniversity, hospital or other
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 10 Sep 2019 (actual)
- 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.
Cardiac resynchronization therapy (CRT), or atrial-synchronized biventricular (BiV) pacing, is an FDA-approved device therapy option for heart failure (HF) patients with reduced left ventricular ejection fraction and electrical dyssynchrony. A traditional CRT device has pacing leads implanted within the right atrium (RA), the right ventricle (RV), and within a coronary vein overlying the lateral or posterior left ventricle (LV). Within the past decade, various multi-center randomized controlled trials have reported improved quality of life, aerobic exercise capacity, LV systolic function and structure, as well as decreased hospitalization rates and mortality among patients with HF. Despite improvements in CRT technology with multipoint pacing, quadripolar leads, and adaptive pacing algorithms, approximately 30% of patients do not clinically benefit and are considered non-responders. This study looks to optimize new CRT device recipients using information obtained from standard ECG machines.
Detailed description
This is a prospective, randomized study designed to evaluate if CRT device optimization, guided by electrocardiography, improves echocardiographic and clinical outcomes among HF patients with a CRT device implanted for standard indications. All patients will have measurement of electrocardiograms at a range of device settings. Patients will be randomized in a 1:1 ratio to either the active comparator arm (standard CRT programming), or the experimental arm (CRT device programmed by the information obtained by ECGs). Standard CRT programming used in this study is simultaneous biventricular (BiV) pacing with a fixed atrioventricular delay. At 6 months, control patients who were initially randomized to standard programming will have programming changed based on the ECG optimization information. Patients will be blinded to randomization. Change of LV size and function will be performed prior to randomization, and again ~6 and ~12 months following CRT implant in both subgroups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 randomization - active comparator and experimental arm (note: at 6 months the control arm will crossover)
| Arm | Type | Receives |
|---|---|---|
| Standard CRT Programming, then ECG CRT Optimization | Active comparator | Device: Reprogramming of CRT Device Settings to Optimal Electrical SynchronyThe control arm patients will have standard CRT programming for the first 6 months, and then will be reprogrammed based on the ECG CRT optimization information for the following 6 months |
| ECG CRT Optimization | Experimental | Device: Reprogramming of CRT Device Settings to Optimal Electrical SynchronyThe experimental arm patients will have CRT device reprogrammed based on the ECG CRT optimization information for 12 months. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients (or their legal guardian) must be willing to provide informed consent and sign a data privacy authorization (HIPAA) form
- Age greater than or equal 18 years
- Pre-CRT EF less than or equal 40%
- Patients will be receiving or have received a first-time CRT device for standard clinical indications within ~2 months of study enrollment
- Adequate echocardiographic images for LV EF and LV ESV determination
Key exclusion criteria (6 listed)
- Patients who are pregnant or may become pregnant
- Patient has a history of severe allergic reactions from ECG gel/ electrode adhesives
- Patient has a His Bundle pacing lead
- Patient has right bundle branch block (RBBB)
- Patient is enrolled in concurrent research study that would potentially confound the results of this study
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 |
|---|---|---|
| Reprogramming of CRT Device Settings to Optimal Electrical SynchronyReprogramming of CRT device to maximize the benefit based on the ECG CRT optimization information. | Device | ECG CRT Optimization, Standard CRT Programming, then ECG CRT Optimization |
Primary outcome
Change in left ventricular size
Time frame: 6 months
Change in left ventricular end-systolic volume (LVESV), measured by echocardiogram, in patients in the experimental arm vs active comparator arm
4 secondary outcomes
Change in left ventricular function
Time frame: 6 months
Change in left ventricular size
Time frame: 6 months
Change in left ventricular size
Time frame: 6 months
Change in left ventricular size
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Individual participant dataSharing planned: No. We do not plan to share IPD with other researchers
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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.
Alan J Bank, MD principal investigator
United Heart & Vascular - Allina Health 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 Reprogramming of CRT Device Settings to Optimal Electrical Synchrony in people with Heart Failure, Systolic, run by Allina Health System 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 6 inclusion and 6 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 9 Jun 2022. 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 Christopher D Brown (651-241-2806, christopher.brown2@allina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in left ventricular size (time frame: 6 months). 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 9 Jun 2022.