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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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Unpublished Holter data from our center indicates that the ADL rate for most patients in our practice is between 50-70bpm rather than 95bpm.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reprogramming dual chamber pacemaker | Device | Reprogramming rate response feature in the Medtronic pacemaker to each arm with crossover |
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| Measure | Description | Time Frame |
|---|---|---|
| symptom improvement | Patient report symptoms by clinician interview and patient symptom questionnaire | study duration of 9 mths |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | study duration of 9 mths |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Arun Rao, MD | Wellmont CVA Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wellmont CVA Heart Institute | Kingsport | Tennessee | 37660 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7885929 | Background | 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. | |
| 7835358 | Background | Lau 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. |
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| ID | Term |
|---|---|
| D012804 | Sick Sinus Syndrome |
| ID | Term |
|---|---|
| D001146 | Arrhythmia, Sinus |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 1712957 | Background | Oto 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. |
| D006327 |
| Heart Block |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |