Sinus Node DysfunctionCRIPSNCT02027909
A Comparison of Rate Response Performance in Pacemaker Patients With an Indication of Sinus Node Dysfunction
An observational study of Sinus Node Dysfunction, run by Arun Rao at 1 site in United States.
Trial summary
Providing ideal rate response to patients should improve their quality of life and ability to execute activities of daily living. Medtronic pacemakers provide rate response pacing by utilizing dual zone programming to specify an "activities of daily living" (ADL) response rate and an "exertion" response rate. Read more about this study
- Who is it for?
- Ages 60 to 95 years
- Conditions the study is for
- Sinus Node Dysfunction
- What is being tested?
- Reprogramming dual chamber pacemaker
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Apr 2015
- How long will I take part?
- 9 Months
- 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 60 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: New implantation of a dual chamber pacemaker due to symptomatic sinus dysfunction or chronotropic incompetence defined as exercise heart rate less than 100 beats per minute
Who may be able to join
- Diagnosis of hypertension
- Sinus node dysfunction
- New implantation of a dual chamber pacemaker due to symptomatic sinus dysfunction or chronotropic incompetence defined as exercise heart rate less than 100 beats per minute
Who cannot join
- Second or Third degree AV block
- Age less than 60 or greater than 95 years
- EF less than 45%
- Patients that are not ambulatory
- Persistent atrial fibrillation (atrial fibrillation lasting greater than 7 days)
- Permanent atrial fibrillation (atrial fibrillation lasting great than 1 year)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wellmont CVA Heart Institute
Kingsport, Tennessee, 37660
About this study
Official title: A Comparison of Rate Response Performance in Pacemaker Patients With an Indication of Sinus Node Dysfunction.
Providing ideal rate response to patients should improve their quality of life and ability to execute activities of daily living.
Medtronic pacemakers provide rate response pacing by utilizing dual zone programming to specify an "activities of daily living" (ADL) response rate and an "exertion" response rate. There is much data to support the target heart rate for an exercise response but the data to support the programming of the ADL rate is lacking.
Read the detailed description
Medtronic pacemakers provide rate response pacing by utilizing dual zone programming to specify an "activities of daily living" (ADL) response rate and an "exertion" response rate. There is much data to support the target heart rate for an exercise response but the data to support the programming of the ADL rate is lacking.
Unpublished Holter data from our center indicates that the ADL rate for most patients in our practice is between 50-70bpm rather than 95bpm. Moreover, this increased ADL rate may impact diastolic filling times and adversely impact cardiac output.
- Conditions
- Sinus Node Dysfunction
- Being tested
- Reprogramming dual chamber pacemaker
- Keywords
- Sinus Node Dysfunction
- 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.
Reprogramming dual chamber pacemakerDevice
Also called Medtronic dual chamber pacemaker
Reprogramming rate response feature in the Medtronic pacemaker to each arm with crossover
| Study group | Role | What they receive |
|---|---|---|
| Therapy group one | Lower rate of 60 bpm and out of the box rate response settings of an ADL Rate of 95 bpm and rate profile optimization on with the only change being adjusting the activity threshold from med/low to low. Receives: Device: Reprogramming dual chamber pacemaker | |
| Therapy group two | Rate response programming will be determined by an exercise test consisting of a 2 minute hall walk will be performed at the 2 week follow up and set points will be manually adjusted to achieve an ADL rate of 95 bpm. Rate Profile Optimization will be turned off. Activity threshold is programmed to low. Receives: Device: Reprogramming dual chamber pacemaker | |
| Therapy group three | Lower rate of 60 bpm and the ADL rate based upon 220- age x 55%. Activity threshold is programmed to low. Rate Profile Optimization will be turned ON. Receives: Device: Reprogramming dual chamber pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptom improvement
Patient report symptoms by clinician interview and patient symptom questionnaire
Measured: study duration of 9 mths
Secondary outcomes (1)
improvement seen on device interrogations and reported improvement of symptoms
Two minute hall walk distance Heart rate histograms and sensor indicated rate profile obtained from device interrogation Patient reported symptoms Patient symptom questionnaire Quality of life as measured by SF-36
Measured: study duration of 9 mths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startNov 2011
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sinus Node DysfunctionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Arun Rao
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor-investigator, Arun Rao, Wellmont CVA Heart Institute
- Investigators
- Arun Rao, MD, Principal investigator, Wellmont CVA Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027909
- Sponsor's protocol ID
- CRIPS
- Acronym
- CRIPS
- Status last verified
- Apr 2018
- First submitted
- 31 Dec 2013
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lau CP, Leung SK. Clinical usefulness of rate adaptive pacing systems: what should we assess? Pacing Clin Electrophysiol. 1994 Dec;17(12 Pt 1):2233-5. doi: 10.1111/j.1540-8159.1994.tb02370.x. No abstract available.
PubMed 7885929Lau CP, Tai YT, Leung WH, Wong CK, Lee P, Chung FL. Rate adaptive pacing in sick sinus syndrome: effects of pacing modes and intrinsic conduction on physiological responses, arrhythmias, symptomatology and quality of life. Eur Heart J. 1994 Nov;15(11):1445-55. doi: 10.1093/oxfordjournals.eurheartj.a060413.
PubMed 7835358Oto MA, Muderrisoglu H, Ozin MB, Korkmaz ME, Karamehmetoglu A, Oram A, Oram E, Ugurlu S. Quality of life in patients with rate responsive pacemakers: a randomized, cross-over study. Pacing Clin Electrophysiol. 1991 May;14(5 Pt 1):800-6. doi: 10.1111/j.1540-8159.1991.tb04110.x.
PubMed 1712957
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Rate Response Performance in Pacemaker Patients With an Indication of Sinus Node Dysfunction.
- ClinicalTrials.gov ID
- NCT02027909
- Acronym / sponsor ID
- CRIPS / CRIPS
- Conditions
- Sinus Node Dysfunction
- Keywords
- Sinus Node Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Arun RaoUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Nov 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 6 Jan 2014 (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.
Providing ideal rate response to patients should improve their quality of life and ability to execute activities of daily living.
Medtronic pacemakers provide rate response pacing by utilizing dual zone programming to specify an "activities of daily living" (ADL) response rate and an "exertion" response rate. There is much data to support the target heart rate for an exercise response but the data to support the programming of the ADL rate is lacking.
Detailed description
Medtronic pacemakers provide rate response pacing by utilizing dual zone programming to specify an "activities of daily living" (ADL) response rate and an "exertion" response rate. There is much data to support the target heart rate for an exercise response but the data to support the programming of the ADL rate is lacking.
Unpublished Holter data from our center indicates that the ADL rate for most patients in our practice is between 50-70bpm rather than 95bpm. Moreover, this increased ADL rate may impact diastolic filling times and adversely impact cardiac output.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Therapy group one | – | Device: Reprogramming dual chamber pacemakerLower rate of 60 bpm and out of the box rate response settings of an ADL Rate of 95 bpm and rate profile optimization on with the only change being adjusting the activity threshold from med/low to low. |
| Therapy group two | – | Device: Reprogramming dual chamber pacemakerRate response programming will be determined by an exercise test consisting of a 2 minute hall walk will be performed at the 2 week follow up and set points will be manually adjusted to achieve an ADL rate of 95 bpm. Rate Profile Optimization will be turned off. Activity threshold is programmed to low. |
| Therapy group three | – | Device: Reprogramming dual chamber pacemakerLower rate of 60 bpm and the ADL rate based upon 220- age x 55%. Activity threshold is programmed to low. Rate Profile Optimization will be turned ON. |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- New implantation of a dual chamber pacemaker due to symptomatic sinus dysfunction or chronotropic incompetence defined as exercise heart rate less than 100 beats per minute
Key inclusion criteria (3 listed)
- Diagnosis of hypertension
- Sinus node dysfunction
- New implantation of a dual chamber pacemaker due to symptomatic sinus dysfunction or chronotropic incompetence defined as exercise heart rate less than 100 beats per minute
Key exclusion criteria (6 listed)
- Second or Third degree AV block
- Age less than 60 or greater than 95 years
- EF less than 45%
- Patients that are not ambulatory
- Persistent atrial fibrillation (atrial fibrillation lasting greater than 7 days)
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 |
|---|---|---|
| Reprogramming dual chamber pacemakerAlso: Medtronic dual chamber pacemakerReprogramming rate response feature in the Medtronic pacemaker to each arm with crossover | Device | Therapy group one, Therapy group three, Therapy group two |
Primary outcome
symptom improvement
Time frame: study duration of 9 mths
Patient report symptoms by clinician interview and patient symptom questionnaire
1 secondary outcome
improvement seen on device interrogations and reported improvement of symptoms
Time frame: study duration of 9 mths
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 25 Apr 2018.
- Background: PubMed 7885929Lau CP, Leung SK. Clinical usefulness of rate adaptive pacing systems: what should we assess? Pacing Clin Electrophysiol. 1994 Dec;17(12 Pt 1):2233-5. doi: 10.1111/j.1540-8159.1994.tb02370.x. No abstract available.
- Background: PubMed 7835358Lau CP, Tai YT, Leung WH, Wong CK, Lee P, Chung FL. Rate adaptive pacing in sick sinus syndrome: effects of pacing modes and intrinsic conduction on physiological responses, arrhythmias, symptomatology and quality of life. Eur Heart J. 1994 Nov;15(11):1445-55. doi: 10.1093/oxfordjournals.eurheartj.a060413.
- Background: PubMed 1712957Oto MA, Muderrisoglu H, Ozin MB, Korkmaz ME, Karamehmetoglu A, Oram A, Oram E, Ugurlu S. Quality of life in patients with rate responsive pacemakers: a randomized, cross-over study. Pacing Clin Electrophysiol. 1991 May;14(5 Pt 1):800-6. doi: 10.1111/j.1540-8159.1991.tb04110.x.
- 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.
Arun Rao, MD principal investigator
Wellmont CVA Heart Institute
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 Sinus Node Dysfunction, run by Arun Rao 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 6 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 25 Apr 2018. 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?
symptom improvement (time frame: study duration of 9 mths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02027909, which also lists 3 linked publications.
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 25 Apr 2018.