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

April 23, 2018 updated by: Arun Rao

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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Unpublished Holter data from our center indicates that the ADL rate for most patients in our practice is between 50-70bpm rather than 95bpm.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

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Wellmont CVA Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Therapy group one
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.
Device: Reprogramming dual chamber pacemaker
Reprogramming rate response feature in the Medtronic pacemaker to each arm with crossover
Other Names:
  • Medtronic dual chamber pacemaker
Therapy group two
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.
Device: Reprogramming dual chamber pacemaker
Reprogramming rate response feature in the Medtronic pacemaker to each arm with crossover
Other Names:
  • Medtronic dual chamber pacemaker
Therapy group three
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.
Device: Reprogramming dual chamber pacemaker
Reprogramming rate response feature in the Medtronic pacemaker to each arm with crossover
Other Names:
  • Medtronic dual chamber pacemaker

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
symptom improvement
Time Frame: study duration of 9 mths
Patient report symptoms by clinician interview and patient symptom questionnaire
study duration of 9 mths

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
study duration of 9 mths

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arun Rao

Collaborators

Medtronic

Investigators

  • Principal Investigator: Arun Rao, MD, Wellmont CVA Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

December 31, 2013

First Submitted That Met QC Criteria

January 2, 2014

First Posted (Estimate)

January 6, 2014

Study Record Updates

Last Update Posted (Actual)

April 25, 2018

Last Update Submitted That Met QC Criteria

April 23, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRIPS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sinus Node Dysfunction

Clinical Trials on Reprogramming dual chamber pacemaker

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe