Chronically (i.e. Implanted for at Least Six Months) Dual-chamber PacemakerSAVDNCT01233661
Short Atrioventricular Delay Pacing
A study testing short AVD pacing ; prior (stable) programming in people with Chronically (i.e. Implanted for at Least Six Months) Dual-chamber Pacemaker and Stable Cardiac Status (i.e. no Hospitalizations or Cardiac Medication Changes Within 3 Months), run by University of Pittsburgh at 1 site in United States.
Trial summary
We intend to examine the effects of temporary elevation of atrial wall stress by shortening of the atrioventricular delay in patients with dual-chamber pacemakers. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronically (i.e. Implanted for at Least Six Months) Dual-chamber Pacemaker, Stable Cardiac Status (i.e. no Hospitalizations or Cardiac Medication Changes Within 3 Months)
- What is being tested?
- short AVD pacing ; prior (stable) programming
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jan 2011
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronically (i.e. implanted for at least six months) dual-chamber pacemaker
- Stable cardiac status (i.e. no hospitalizations or cardiac medication changes within 3 months)
- Ability to provide informed consent
Who cannot join
- Age <18 years or >80 years
- Pregnancy (if pregnancy is suspected, a urine pregnancy test will be performed)
- Recent (within 12 months) left ventricular ejection fraction <50%
- Significant valvular heart disease (mitral regurgitation of greater than mild severity, any degree of mitral stenosis, aortic stenosis or insufficiency of greater than mild severity)
- Prior coronary artery bypass graft or valve surgery, recent (i.e. within 3 months) acute coronary syndrome or percutaneous coronary intervention, or chronic stable angina
- History of clinically important atrial or ventricular tachyarrhythmias, defined as complex ventricular ectopy (i.e. couplets, triplets, or ventricular tachycardia), AF, atrial tachycardia, or other supraventricular tachycardias not cured with prior ablative therapy).
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- Significant chronic systemic inflammatory or neoplastic disease
- Chronic renal or hepatic insufficiency. Renal insufficiency will be defined as a creatinine clearance of less than 20 cc/min. Evidence of hepatic insufficiency will consist of abnormal synthetic function (INR >1.4 without oral anticoagulant use, albumin < 3.0 mg/dL) or abnormal clearance function (total bilirubin >2.0).
- Uncorrected thyroid abnormalities
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrial Arrhythmia Center, UPMC
Pittsburgh, Pennsylvania, 15213
About this study
We intend to examine the effects of temporary elevation of atrial wall stress by shortening of the atrioventricular delay in patients with dual-chamber pacemakers.
- Conditions
- Chronically (i.e. Implanted for at Least Six Months) Dual-chamber Pacemaker, Stable Cardiac Status (i.e. no Hospitalizations or Cardiac Medication Changes Within 3 Months)
- Being tested
- short AVD pacing ; prior (stable) programming
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short AVD pacing ; prior (stable) programmingOther
short AVD pacing prior (stable) programming
| Study group | Role | What they receive |
|---|---|---|
| short AVD pacing | Experimental | short AVD pacing Receives: Other: short AVD pacing ; prior (stable) programming |
| prior (stable) programming | No intervention | prior (stable) programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum biomarker concentrations
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronically (i.e. Implanted for at Least Six Months) Dual-chamber PacemakerStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David S. Schwartzman, MD, Principal investigator, Universtity of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233661
- Sponsor's protocol ID
- 08060137
- Acronym
- SAVD
- Status last verified
- Jan 2016
- First submitted
- 2 Nov 2010
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Atrioventricular Delay Pacing
- ClinicalTrials.gov ID
- NCT01233661
- Acronym / sponsor ID
- SAVD / 08060137
- Conditions
- Chronically (i.e. Implanted for at Least Six Months) Dual-chamber Pacemaker, Stable Cardiac Status (i.e. no Hospitalizations or Cardiac Medication Changes Within 3 Months)
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 3 Nov 2010 (estimated)
- 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.
We intend to examine the effects of temporary elevation of atrial wall stress by shortening of the atrioventricular delay in patients with dual-chamber pacemakers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| short AVD pacing | Experimental | Other: short AVD pacing ; prior (stable) programmingshort AVD pacing |
| prior (stable) programming | No intervention | –prior (stable) programming |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronically (i.e. implanted for at least six months) dual-chamber pacemaker
- Stable cardiac status (i.e. no hospitalizations or cardiac medication changes within 3 months)
- Ability to provide informed consent
Key exclusion criteria (9 listed)
- Age <18 years or >80 years
- Pregnancy (if pregnancy is suspected, a urine pregnancy test will be performed)
- Recent (within 12 months) left ventricular ejection fraction <50%
- Significant valvular heart disease (mitral regurgitation of greater than mild severity, any degree of mitral stenosis, aortic stenosis or insufficiency of greater than mild severity)
- Prior coronary artery bypass graft or valve surgery, recent (i.e. within 3 months) acute coronary syndrome or percutaneous coronary intervention, or chronic stable angina
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 |
|---|---|---|
| short AVD pacing ; prior (stable) programmingshort AVD pacing prior (stable) programming | Other | short AVD pacing |
Primary outcome
serum biomarker concentrations
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
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.
David S. Schwartzman, MD principal investigator
Universtity of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing short AVD pacing ; prior (stable) programming in people with Chronically (i.e. Implanted for at Least Six Months) Dual-chamber Pacemaker and Stable Cardiac Status (i.e. no Hospitalizations or Cardiac Medication Changes Within 3 Months), run by University of Pittsburgh 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 9 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: withdrawn, as of the sponsor's last update on 22 Mar 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 withdrawn before enrolling participants, so there are no results.
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?
serum biomarker concentrations (time frame: 30 days). 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 22 Mar 2023.