CardiomyopathiesNCT03253809
Survey of QRS Frequency at Various Left Ventricular Pacing Sites for Cardiac Resynchronization
A study testing Biotronik Vision Guidewire in people with Cardiomyopathies and Congestive Heart Failure, run by The Cleveland Clinic at 1 site in United States.
Trial summary
LV pacing at various sites with recording of ECG and subsequent signal analysis at different sites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathies, Congestive Heart Failure
- What is being tested?
- Biotronik Vision Guidewire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2017to 2 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Standard implantation for cardiac resynchronization ICD or PM implantation
- Cardiomyopathy with LVEF <35%
- QRS duration greater than 120 msec
Who cannot join
- Age less than 18 years
Trial locations and contacts
1 site in 1 country.
About this study
LV pacing at various sites with recording of ECG and subsequent signal analysis at different sites.
Read the detailed description
During routine cardiac resynchronization pacemaker or implantable defibrillator (ICD) implantation (including de-novo and upgrade from standard device, additional pacing within 3 different coronary veins will be performed in combination with a previously implanted right ventricular pacing or ICD lead. The resulting electrocardiogram signal will be analyzed afterwards. A time-frequency analysis (TFA) of several ECG leads at each paced site will be performed and compared. The results of the TFA analysis will not be used to select pacing lead location in this study.
The patient will then receive the left ventricular pacing lead in the standard manner.
- Conditions
- Cardiomyopathies, Congestive Heart Failure
- Being tested
- Biotronik Vision Guidewire
- Medical subject headings
- Cardiomyopathies, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biotronik Vision GuidewireDevice
The apical, mid ventricular and basal sites within the anterior,posterior and lateral coronary sinus branch veins will be paced.
| Study group | Role | What they receive |
|---|---|---|
| Coronary Sinus Branch Pacing | Experimental | After cannulation, pacing impulses will be delivered via a Biotronik Vision Guidewire to 3 sites (apical, mid ventricular, and basal) within each coronary sinus branch receiving venous blood from the anterior, lateral and posterior regions of the ventricle.
ECG signals will be saved digitally for analysis Receives: Device: Biotronik Vision Guidewire |
What is being measured
The primary outcome is the main question the study is designed to answer.
QRS Frequency at Each Paced Location
Time frequency analysis performed at each location
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start12 Jul 2017
- Primary completion2 Nov 2021
- Study completion2 Nov 2021
Why it stopped: Issue with trial administration/conduct
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CardiomyopathiesStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Nonrandomized survey of different pacing sites in the coronary veins.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark J Niebauer, MD, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253809
- Sponsor's protocol ID
- 17-650
- Status last verified
- Feb 2022
- First submitted
- 16 Aug 2017
- Last updated
- 9 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey of QRS Frequency at Various Left Ventricular Pacing Sites for Cardiac Resynchronization
- ClinicalTrials.gov ID
- NCT03253809
- Acronym / sponsor ID
- 17-650
- Conditions
- Cardiomyopathies, Congestive Heart Failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Issue with trial administration/conduct
- Enrolment
- 14 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 12 Jul 2017 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 2 Nov 2021 (actual)
- First posted
- 18 Aug 2017 (actual)
- Results
- Posted 9 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
LV pacing at various sites with recording of ECG and subsequent signal analysis at different sites.
Detailed description
During routine cardiac resynchronization pacemaker or implantable defibrillator (ICD) implantation (including de-novo and upgrade from standard device, additional pacing within 3 different coronary veins will be performed in combination with a previously implanted right ventricular pacing or ICD lead. The resulting electrocardiogram signal will be analyzed afterwards. A time-frequency analysis (TFA) of several ECG leads at each paced site will be performed and compared. The results of the TFA analysis will not be used to select pacing lead location in this study.
The patient will then receive the left ventricular pacing lead in the standard manner.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Nonrandomized survey of different pacing sites in the coronary veins.
| Arm | Type | Receives |
|---|---|---|
| Coronary Sinus Branch Pacing | Experimental | Device: Biotronik Vision GuidewireAfter cannulation, pacing impulses will be delivered via a Biotronik Vision Guidewire to 3 sites (apical, mid ventricular, and basal) within each coronary sinus branch receiving venous blood from the anterior, lateral and posterior regions of the ventricle. ECG signals will be saved digitally for analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Standard implantation for cardiac resynchronization ICD or PM implantation
- Cardiomyopathy with LVEF <35%
- QRS duration greater than 120 msec
Key exclusion criteria (1 listed)
- Age less than 18 years
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 |
|---|---|---|
| Biotronik Vision GuidewireThe apical, mid ventricular and basal sites within the anterior,posterior and lateral coronary sinus branch veins will be paced. | Device | Coronary Sinus Branch Pacing |
Primary outcome
QRS Frequency at Each Paced Location
Time frame: Baseline
Time frequency analysis performed at each location
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Mark J Niebauer, MD, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biotronik Vision Guidewire in people with Cardiomyopathies and Congestive Heart Failure, run by The Cleveland Clinic 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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 9 Mar 2022. 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?
Yes. Results are posted in the registry (first posted 9 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
QRS Frequency at Each Paced Location (time frame: Baseline). 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 Mar 2022.