Heart FailureNCT03367104
Narrow QRS HF Patients Assessed by ECG Belt
An observational study of Heart Failure and Cardiac Resynchronization Therapy, run by Allina Health System at 1 site in United States.
Trial summary
The purpose of this study is to quantitate electrical dyssynchrony in heart failure (HF) patients with a narrow QRS complexes (≤ 130 ms) using the ECG Belt. This is a pilot study that is designed to provide data that can be used in designing and implementing a prospective study of cardiac resynchronization therapy… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Cardiac Resynchronization Therapy
- What is being tested?
- ECG Belt
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2017to 17 Aug 2021
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects and those with heart failure (reduced ejection fraction) with QRS duration ≤ 130 ms.
Who may be able to join
- Subject (or their legal guardian) must be willing to provide informed consent for their participation in the study
- Subject ≥ 18 years old
Who cannot join
- Subject has unhealed-open wounds on the torso and/or has a history of severe allergic reactions from ECG electrode gel
- Subject is enrolled in a concurrent study that could confound the results of this study
- Subject is pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
United Heart & Vascular Clinic
Saint Paul, Minnesota, 55102
About this study
Official title: Electrical Dyssynchrony in Narrow QRS Heart Failure Patients as Assessed by the ECG Belt
The purpose of this study is to quantitate electrical dyssynchrony in heart failure (HF) patients with a narrow QRS complexes (≤ 130 ms) using the ECG Belt. This is a pilot study that is designed to provide data that can be used in designing and implementing a prospective study of cardiac resynchronization therapy (CRT) in narrow QRS patients selected and optimized using the ECG Belt.
- Conditions
- Heart Failure, Cardiac Resynchronization Therapy
- Being tested
- ECG Belt
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG BeltDevice
Assess electrical dyssynchrony with an anterior-posterior body surface mapping system.
| Study group | Role | What they receive |
|---|---|---|
| Normal healthy controls | Not described Receives: Device: ECG Belt | |
| Heart failure patients | Not described Receives: Device: ECG Belt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrical dyssynchrony quantification
Collect ECG data with ECG Belt
Measured: through acute study completion (~60 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start14 Nov 2017
- Primary completion17 Aug 2021
- Study completion17 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
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 Bank, MD, Principal investigator, Allina Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367104
- Sponsor's protocol ID
- ERP 3771
- Status last verified
- Sep 2021
- First submitted
- 4 Dec 2017
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Dyssynchrony in Narrow QRS Heart Failure Patients as Assessed by the ECG Belt
- ClinicalTrials.gov ID
- NCT03367104
- Acronym / sponsor ID
- ERP 3771
- Conditions
- Heart Failure, Cardiac Resynchronization Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Allina Health SystemUniversity, hospital or other
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 17 Aug 2021 (actual)
- Study completion
- 17 Aug 2021 (actual)
- First posted
- 8 Dec 2017 (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.
The purpose of this study is to quantitate electrical dyssynchrony in heart failure (HF) patients with a narrow QRS complexes (≤ 130 ms) using the ECG Belt. This is a pilot study that is designed to provide data that can be used in designing and implementing a prospective study of cardiac resynchronization therapy (CRT) in narrow QRS patients selected and optimized using the ECG Belt.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal healthy controls | – | Device: ECG Belt |
| Heart failure patients | – | Device: ECG Belt |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects and those with heart failure (reduced ejection fraction) with QRS duration ≤ 130 ms.
Key inclusion criteria (2 listed)
- Subject (or their legal guardian) must be willing to provide informed consent for their participation in the study
- Subject ≥ 18 years old
Key exclusion criteria (3 listed)
- Subject has unhealed-open wounds on the torso and/or has a history of severe allergic reactions from ECG electrode gel
- Subject is enrolled in a concurrent study that could confound the results of this study
- Subject is pregnant
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 |
|---|---|---|
| ECG BeltAssess electrical dyssynchrony with an anterior-posterior body surface mapping system. | Device | Heart failure patients, Normal healthy controls |
Primary outcome
Electrical dyssynchrony quantification
Time frame: through acute study completion (~60 minutes)
Collect ECG data with ECG Belt
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Individual participant dataSharing planned: No
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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 Bank, MD principal investigator
Allina Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Cardiac Resynchronization Therapy, run by Allina Health System at 1 site 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrical dyssynchrony quantification (time frame: through acute study completion (~60 minutes)). 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 23 Sep 2021.