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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2015-04-30

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.

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Unpublished Holter data from our center indicates that the ADL rate for most patients in our practice is between 50-70bpm rather than 95bpm.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

Conditions

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Sinus Node Dysfunction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Reprogramming dual chamber pacemaker

Intervention Type DEVICE

Reprogramming rate response feature in the Medtronic pacemaker to each arm with crossover

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.

Reprogramming dual chamber pacemaker

Intervention Type DEVICE

Reprogramming rate response feature in the Medtronic pacemaker to each arm with crossover

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.

Reprogramming dual chamber pacemaker

Intervention Type DEVICE

Reprogramming rate response feature in the Medtronic pacemaker to each arm with crossover

Interventions

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Reprogramming dual chamber pacemaker

Reprogramming rate response feature in the Medtronic pacemaker to each arm with crossover

Intervention Type DEVICE

Other Intervention Names

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Medtronic dual chamber pacemaker

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)

Minimum Eligible Age

60 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No