A Comparison of Rate Response Performance in Pacemaker Patients With an Indication of Sinus Node Dysfunction

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Unpublished Holter data from our center indicates that the ADL rate for most patients in our practice is between 50-70bpm rather than 95bpm.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.

Official Title
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A Comparison of Rate Response Performance in Pacemaker Patients With an Indication of Sinus Node Dysfunction.

Conditions
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Sinus Node Dysfunction

Intervention / Treatment
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* Device: Reprogramming dual chamber pacemaker


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Therapy group one<br>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. | Device: Reprogramming dual chamber pacemaker<br>* Reprogramming rate response feature in the Medtronic pacemaker to each arm with crossover<br>* Other names: Medtronic dual chamber pacemaker;|
| Therapy group two<br>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. | Device: Reprogramming dual chamber pacemaker<br>* Reprogramming rate response feature in the Medtronic pacemaker to each arm with crossover<br>* Other names: Medtronic dual chamber pacemaker;|
| Therapy group three<br>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. | Device: Reprogramming dual chamber pacemaker<br>* Reprogramming rate response feature in the Medtronic pacemaker to each arm with crossover<br>* Other names: Medtronic dual chamber pacemaker;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptom improvement | Patient report symptoms by clinician interview and patient symptom questionnaire | study duration of 9 mths | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sinus Node Dysfunction