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OpenTrials
Completed

NCT Number: NCT02027909

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

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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Key information

Conditions

Sinus Node Dysfunction Arrhythmia, Sinus Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sick Sinus Syndrome

Age range

60 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wellmont CVA Heart Institute

Kingsport, Tennessee, 37660, United States

About this study

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Unpublished Holter data from our center indicates that the ADL rate for most patients in our practice is between 50-70bpm rather than 95bpm.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Reprogramming dual chamber pacemaker

Device

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

Other names: Medtronic dual chamber pacemaker

Primary outcomes

  1. symptom improvement

    Time frame: study duration of 9 mths

    Patient report symptoms by clinician interview and patient symptom questionnaire

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Arun Rao

Other

Collaborators

  • Medtronic

Registry information

Official study title

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

Acronym: CRIPS

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 6, 2014
Registry last updated
Apr 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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