Clinical trial NCT02027909: A Comparison of Rate Response Performance in Pacemaker Patients With an Indication of Sinus Node Dysfunction
Official title: A Comparison of Rate Response Performance in Pacemaker Patients With an Indication of Sinus Node Dysfunction.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sinus Node Dysfunction
Keywords: Sinus Node Dysfunction
Lead sponsor: Wellmont CVA Heart Institute
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2014-01-06
Enrollment: 8
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

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Unpublished Holter data from our center indicates that the ADL rate for most patients in our practice is between 50-70bpm rather than 95bpm.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

Eligibility criteria: 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)

Primary outcomes:
measure: symptom improvement
timeFrame: study duration of 9 mths
Secondary outcomes:
measure: improvement seen on device interrogations and reported improvement of symptoms
timeFrame: study duration of 9 mths
Other outcomes:
Locations:
city: Kingsport
country: United States
facility: Wellmont CVA Heart Institute
state: Tennessee
Study officials:
affiliation: Wellmont CVA Heart Institute
name: Arun Rao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.