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

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Comparison of Rate Response Performance in Pacemaker Patients With an Indication of 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 Summary:

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Unpublished Holter data from our center indicates that the ADL rate for most patients in our practice is between 50-70bpm rather than 95bpm.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


Sponsor: Arun Rao

Current Primary Outcome: symptom improvement [ Time Frame: study duration of 9 mths ]

Patient report symptoms by clinician interview and patient symptom questionnaire


Original Primary Outcome: Same as current

Current Secondary Outcome: improvement seen on device interrogations and reported improvement of symptoms [ Time Frame: 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


Original Secondary Outcome: Same as current

Information By: Wellmont CVA Heart Institute

Dates:
Date Received: December 31, 2013
Date Started: November 2011
Date Completion: December 2014
Last Updated: January 2, 2014
Last Verified: January 2014