Sinus Node Disease.NCT01611389
Minimizing Ventricular Pacing
A study testing Prolonging atrioventricular (AV) delay. and Standard atrioventricular (AV) delay. in people with Sinus Node Disease. and First Degree Atrioventricular Block., run by Military Institute od Medicine National Research Institute at 1 site in Poland.
Trial summary
The aim of this study is to evaluate the effect of minimizing right ventricular pacing in dual-chamber pacemaker patients with sinus node disease (SND) and first degree atrioventricular block (AVIB)on exercise capacity, quality of life and other heart failure measures. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Sinus Node Disease., First Degree Atrioventricular Block.
- What is being tested?
- Prolonging atrioventricular (AV) delay. and Standard atrioventricular (AV) delay.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2010to Dec 2012
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- prolonged PQ interval > 200 ms,
- percentage of right ventricular pacing with standard AV delay > 90.
Who cannot join
- second or third degree atrioventricular block,
- permanent atrial fibrillation.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Military Institute of Medicine
Warsaw, 04-141
Krystian Krzyżanowski, MD
About this study
Official title: Minimizing Right Ventricular Pacing in Dual-chamber Pacemaker Patients With Sinus Node Disease and First Degree Atrioventricular Block.
The aim of this study is to evaluate the effect of minimizing right ventricular pacing in dual-chamber pacemaker patients with sinus node disease (SND) and first degree atrioventricular block (AVIB)on exercise capacity, quality of life and other heart failure measures.
- Being tested
- Prolonging atrioventricular (AV) delay., Standard atrioventricular (AV) delay.
- Medical subject headings
- Sick Sinus Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonging atrioventricular (AV) delay.Device
Prolonging atrioventricular (AV) delay to maximum 350 ms.
Standard atrioventricular (AV) delay.Device
Standard atrioventricular (AV) delay - approximately 180/140 ms depending on heart rate.
| Study group | Role | What they receive |
|---|---|---|
| Long AV delay. | Experimental | Not described Receives: Device: Prolonging atrioventricular (AV) delay. |
| Short AV delay. | Active comparator | Not described Receives: Device: Standard atrioventricular (AV) delay. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen uptake (cardiopulmonary exercise testing).
Measured: 3 months
Secondary outcomes (5)
Left ventricular ejection fraction.
Assessed in echocardiography.
Measured: 3 months
Quality of life
SF36 questionnaire.
Measured: 3 months
Arrhythmia
24 hours Holter monitoring, pacemaker storage data.
Measured: 3 months
Ventilatory anaerobic threshold (cardiopulmonary exercise testing)
Measured: 3 months
VE/VCO2 slope (cardiopulmonary exercise testing).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startSep 2010
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus Node Disease.Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Military Institute od Medicine National Research Institute
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611389
- Sponsor's protocol ID
- 83562
- Other IDs
- N N402 533539
- Status last verified
- May 2012
- First submitted
- 31 May 2012
- Last updated
- 5 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimizing Right Ventricular Pacing in Dual-chamber Pacemaker Patients With Sinus Node Disease and First Degree Atrioventricular Block.
- ClinicalTrials.gov ID
- NCT01611389
- Acronym / sponsor ID
- 83562
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Military Institute od Medicine National Research InstituteUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 5 Jun 2012 (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.
The aim of this study is to evaluate the effect of minimizing right ventricular pacing in dual-chamber pacemaker patients with sinus node disease (SND) and first degree atrioventricular block (AVIB)on exercise capacity, quality of life and other heart failure measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long AV delay. | Experimental | Device: Prolonging atrioventricular (AV) delay. |
| Short AV delay. | Active comparator | Device: Standard atrioventricular (AV) delay. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- prolonged PQ interval > 200 ms,
- percentage of right ventricular pacing with standard AV delay > 90.
Key exclusion criteria (2 listed)
- second or third degree atrioventricular block,
- permanent atrial fibrillation.
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 |
|---|---|---|
| Prolonging atrioventricular (AV) delay.Prolonging atrioventricular (AV) delay to maximum 350 ms. | Device | Long AV delay. |
| Standard atrioventricular (AV) delay.Standard atrioventricular (AV) delay - approximately 180/140 ms depending on heart rate. | Device | Short AV delay. |
Primary outcome
Oxygen uptake (cardiopulmonary exercise testing).
Time frame: 3 months
5 secondary outcomes
Left ventricular ejection fraction.
Time frame: 3 months
Quality of life
Time frame: 3 months
Arrhythmia
Time frame: 3 months
Ventilatory anaerobic threshold (cardiopulmonary exercise testing)
Time frame: 3 months
VE/VCO2 slope (cardiopulmonary exercise testing).
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonging atrioventricular (AV) delay. and Standard atrioventricular (AV) delay. in people with Sinus Node Disease. and First Degree Atrioventricular Block., run by Military Institute od Medicine National Research Institute at 1 site in Poland.
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 2 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: status not confirmed, as of the sponsor's last update on 5 Jun 2012. 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Krystian Krzyżanowski, MD (512 356 207 ext. 48, krystian.krzyzanowski@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen uptake (cardiopulmonary exercise testing). (time frame: 3 months). 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 2012.