ExerciseSLAVSMENCT03859167
Study of the Loss of AV Synchrony at Maximum Exercise
An observational study of Exercise and Pacemaker, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Investigators will identify a group of patients with complete heart block and a dual chamber pacemaker who will be expected to be able to exercise on a treadmill. Investigators will utilize symptom logs, cuff and continuous blood pressure monitoring. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Exercise, Pacemaker, Blood Pressure
- What is being tested?
- Stress Test
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2019to 10 Apr 2023
- 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 to 60 years
- All sexes
- Adult
Study population: patients from cardiology clinic
Who may be able to join
- Complete AV Block
- Age less than 60
- Easily programmable dual chamber pacemaker
Who cannot join
- Age > 60
- Significant Heart Failure
- Significant angina
- History of claudication
- Significant orthopedic issues
- Evidence of sinus node dysfunction
- Taking beta blockers or non-dihydropyridine calcium channel blockers
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: SLAVSME - Study of the Loss of AV Synchrony at Maximum Exercise
Investigators will identify a group of patients with complete heart block and a dual chamber pacemaker who will be expected to be able to exercise on a treadmill. Investigators will utilize symptom logs, cuff and continuous blood pressure monitoring. It is planned to study the symptomatic impact of loss of AV synchrony at significant levels of exercise.
- Conditions
- Exercise, Pacemaker, Blood Pressure
- Being tested
- Stress Test
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress TestOther
Participants will reach maximum exercise on a treadmill and results will be collected and recorded.
| Study group | Role | What they receive |
|---|---|---|
| Participants with AV block with pacemaker | Participants will have a stress test, and results will be collected and recorded. Receives: Other: Stress Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants with Loss of AV synchrony at maximum exercise
Measured: Baseline to end of stress test approximately 60 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start10 Sep 2019
- Primary completion10 Apr 2023
- Study completion10 Apr 2023
Why it stopped: No Enrollments after COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Jay Montgomery, Vanderbilt University Medical Center
- Investigators
- Jay A. Montgomery, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859167
- Sponsor's protocol ID
- 190470
- Acronym
- SLAVSME
- Status last verified
- Apr 2023
- First submitted
- 27 Feb 2019
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SLAVSME - Study of the Loss of AV Synchrony at Maximum Exercise
- ClinicalTrials.gov ID
- NCT03859167
- Acronym / sponsor ID
- SLAVSME / 190470
- Conditions
- Exercise, Pacemaker, Blood Pressure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No Enrollments after COVID
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 1 Mar 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.
Investigators will identify a group of patients with complete heart block and a dual chamber pacemaker who will be expected to be able to exercise on a treadmill. Investigators will utilize symptom logs, cuff and continuous blood pressure monitoring. It is planned to study the symptomatic impact of loss of AV synchrony at significant levels of exercise.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with AV block with pacemaker | – | Other: Stress TestParticipants will have a stress test, and results will be collected and recorded. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- patients from cardiology clinic
Key inclusion criteria (3 listed)
- Complete AV Block
- Age less than 60
- Easily programmable dual chamber pacemaker
Key exclusion criteria (7 listed)
- Age > 60
- Significant Heart Failure
- Significant angina
- History of claudication
- Significant orthopedic issues
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 |
|---|---|---|
| Stress TestParticipants will reach maximum exercise on a treadmill and results will be collected and recorded. | Other | Participants with AV block with pacemaker |
Primary outcome
The number of participants with Loss of AV synchrony at maximum exercise
Time frame: Baseline to end of stress test approximately 60 minutes.
Results and safety
The study was stopped early (reason given: No Enrollments after COVID). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
Jay A. Montgomery, MD principal investigator
Vanderbilt University Medical Center
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 Exercise and Pacemaker, run by Vanderbilt University Medical Center 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 7 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 14 Apr 2023. 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 was stopped early (reason given: No Enrollments after COVID). Results are not available in the source record.
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?
The number of participants with Loss of AV synchrony at maximum exercise (time frame: Baseline to end of stress test approximately 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 14 Apr 2023.