Sinus Node Dysfunction
Conditions
Keywords
Sinus Node Dysfunction
Brief 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. 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 Unpublished Holter data from our center indicates that the ADL rate for most patients in our practice is between 50-70bpm rather than 95bpm.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.
Interventions
DEVICEReprogramming dual chamber pacemaker
Reprogramming rate response feature in the Medtronic pacemaker to each arm with crossover
Sponsors
Medtronic
Arun Rao
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to 95 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| symptom improvement | study duration of 9 mths | Patient report symptoms by clinician interview and patient symptom questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| improvement seen on device interrogations and reported improvement of symptoms | study duration of 9 mths | 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 |
Countries
United States
Outcome results
None listed