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

Completed

• Conditions: Sinus Node Dysfunction
• Interventions: Device: Reprogramming dual chamber pacemaker

• Registration Number: NCT02027909
• Lead Sponsor: Arun Rao

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Unpublished Holter data from our center indicates that the ADL rate for most patients in our practice is between 50-70bpm rather than 95bpm.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

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2013-12-31
• Study First Submitted QC: 2014-01-02
• Study First Posted: 2014-01-06
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-23
• Last Update Posted: 2018-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Therapy group three	Reprogramming dual chamber pacemaker	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.
Therapy group one	Reprogramming dual chamber pacemaker	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.
Therapy group two	Reprogramming dual chamber pacemaker	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.

Primary Outcome Measures

Name	Time	Method
symptom improvement	study duration of 9 mths	Patient report symptoms by clinician interview and patient symptom questionnaire

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Wellmont CVA Heart Institute; 🇺🇸 Kingsport, Tennessee, United States