Cardiac Resynchronization TherapyNCT06444386
ECGi of SyncAV With MultiPoint Pacing
An observational study of Cardiac Resynchronization Therapy, run by Abbott Medical Devices at 1 site in United States.
Trial summary
The objective of this clinical study was to evaluate the impact of Multipoint Pacing (MPP) and SyncAV programming on ventricular electrical activation time and activation sequence using noninvasive electrocardiographic imaging (ECGi) in patients receiving cardiac resynchronization therapy (CRT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Resynchronization Therapy
- What is being tested?
- MPP + SyncAV
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2021to 1 Apr 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The intended population for this clinical investigation consisted of patients over the age of 18 years who have been previously implanted with an Abbott CRT device capable of SyncAV and MultiPoint Pacing. This clinical investigation enrolled male and female subjects from the general heart failure population. Subjects must have met all eligibility criteria and provide written informed consent prior to conducting any investigation-specific procedures not considered standard of care.
Who may be able to join
- Patients previously implanted with a SyncAV and MPP-enabled Abbott Quadripolar CRT pacing system
- Patient must be > 18 years of age, able to provide informed consent and willing to comply with study requirements
- Sinus (or atrial paced) rhythm with intact AV conduction with PR interval ≤ 250 ms
- Patient has documented Left Bundle Branch Block (LBBB)
Who cannot join
- Resting heart rate > 100 bpm
- AV Block (1st degree with PR> 250 ms, 2nd or 3rd degree)
- Documented persistent atrial tachycardia or atrial fibrillation at the moment of enrollment or patients not likely to remain in sinus (or atrial paced) rhythm for the duration of the study
- Recent (< 3 months) myocardial infarction, ablation, electrolyte imbalance, or any condition within the last 90 days that would contraindicate for CRT programming changes in the opinion of the investigator
- Women who are pregnant or plan to become pregnant during the study course
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electrocardiographic Imaging of MultiPoint Pacing and SyncAV: Understanding Optimized Programming for Cardiac Resynchronization Therapy
The objective of this clinical study was to evaluate the impact of Multipoint Pacing (MPP) and SyncAV programming on ventricular electrical activation time and activation sequence using noninvasive electrocardiographic imaging (ECGi) in patients receiving cardiac resynchronization therapy (CRT).
- Conditions
- Cardiac Resynchronization Therapy
- Being tested
- MPP + SyncAV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPP + SyncAVDevice
Cardiac resynchronization therapy (CRT) features of MultiPoint Pacing (MPP) and SyncAV (dynamic atrioventricular delay programming) enabled.
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular activation time
Evaluate acute changes in left ventricular (LV) electrical activation time measured with ECGi resulting from various CRT pacing configurations with MPP and SyncAV
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start29 Sep 2021
- Primary completion12 Jul 2023
- Study completion1 Apr 2024
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.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444386
- Sponsor's protocol ID
- ABT-CIP-10292
- Status last verified
- Jun 2024
- First submitted
- 30 May 2024
- Last updated
- 5 Jun 2024
- 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 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrocardiographic Imaging of MultiPoint Pacing and SyncAV: Understanding Optimized Programming for Cardiac Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT06444386
- Acronym / sponsor ID
- ABT-CIP-10292
- Conditions
- Cardiac Resynchronization Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 5 Jun 2024 (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 objective of this clinical study was to evaluate the impact of Multipoint Pacing (MPP) and SyncAV programming on ventricular electrical activation time and activation sequence using noninvasive electrocardiographic imaging (ECGi) in patients receiving cardiac resynchronization therapy (CRT).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The intended population for this clinical investigation consisted of patients over the age of 18 years who have been previously implanted with an Abbott CRT device capable of SyncAV and MultiPoint Pacing. This clinical investigation enrolled male and female subjects from the general heart failure population. Subjects must have met all eligibility criteria and provide written informed consent prior to conducting any investigation-specific procedures not considered standard of care.
Key inclusion criteria (4 listed)
- Patients previously implanted with a SyncAV and MPP-enabled Abbott Quadripolar CRT pacing system
- Patient must be > 18 years of age, able to provide informed consent and willing to comply with study requirements
- Sinus (or atrial paced) rhythm with intact AV conduction with PR interval ≤ 250 ms
- Patient has documented Left Bundle Branch Block (LBBB)
Key exclusion criteria (5 listed)
- Resting heart rate > 100 bpm
- AV Block (1st degree with PR> 250 ms, 2nd or 3rd degree)
- Documented persistent atrial tachycardia or atrial fibrillation at the moment of enrollment or patients not likely to remain in sinus (or atrial paced) rhythm for the duration of the study
- Recent (< 3 months) myocardial infarction, ablation, electrolyte imbalance, or any condition within the last 90 days that would contraindicate for CRT programming changes in the opinion of the investigator
- Women who are pregnant or plan to become pregnant during the study course
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 |
|---|---|---|
| MPP + SyncAVCardiac resynchronization therapy (CRT) features of MultiPoint Pacing (MPP) and SyncAV (dynamic atrioventricular delay programming) enabled. | Device | – |
Primary outcome
Left ventricular activation time
Time frame: 1 day
Evaluate acute changes in left ventricular (LV) electrical activation time measured with ECGi resulting from various CRT pacing configurations with MPP and SyncAV
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 5 Jun 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cardiac Resynchronization Therapy, run by Abbott Medical Devices 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 4 inclusion and 5 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 5 Jun 2024. 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?
Left ventricular activation time (time frame: 1 day). 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 5 Jun 2024.