Trial record 1 of 48 for:    "sick sinus syndrome" OR "sinus node disease" OR "sinus node dysfunction"
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A Comparison of Rate Response Performance in Pacemaker Patients With an Indication of Sinus Node Dysfunction (CRIPS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Wellmont CVA Heart Institute
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Arun Rao, Wellmont CVA Heart Institute
ClinicalTrials.gov Identifier:
NCT02027909
First received: December 31, 2013
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Sinus Node Dysfunction
Device: Reprogramming dual chamber pacemaker

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison of Rate Response Performance in Pacemaker Patients With an Indication of Sinus Node Dysfunction.

Resource links provided by NLM:


Further study details as provided by Wellmont CVA Heart Institute:

Primary Outcome Measures:
  • symptom improvement [ Time Frame: study duration of 9 mths ] [ Designated as safety issue: No ]
    Patient report symptoms by clinician interview and patient symptom questionnaire


Secondary Outcome Measures:
  • improvement seen on device interrogations and reported improvement of symptoms [ Time Frame: study duration of 9 mths ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 21
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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 Name: Medtronic dual chamber pacemaker
Active Comparator: 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 Name: Medtronic dual chamber pacemaker
Active Comparator: 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 Name: Medtronic dual chamber pacemaker

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

Ages Eligible for Study:   60 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02027909

Contacts
Contact: Ashley Sparks, LPN 423-230-5062 asparks@mycva.com
Contact: Terrie Walker, BSN 423-230-5643 twalker@mycva.com

Locations
United States, Tennessee
Wellmont CVA Heart Institute Recruiting
Kingsport, Tennessee, United States, 37660
Contact: Ashley Sparks, LPN    423-230-5062    asparks@mycva.com   
Contact: Terrie Walker, BSN    423-230-5643    twalker@mycva.com   
Principal Investigator: Arun Rao, MD         
Sponsors and Collaborators
Arun Rao
Medtronic
Investigators
Principal Investigator: Arun Rao, MD Wellmont CVA Heart Institute
  More Information

Publications:
Responsible Party: Arun Rao, Arun Rao, MD. FACC, Wellmont CVA Heart Institute
ClinicalTrials.gov Identifier: NCT02027909     History of Changes
Other Study ID Numbers: CRIPS
Study First Received: December 31, 2013
Last Updated: January 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Wellmont CVA Heart Institute:
Sinus Node Dysfunction

Additional relevant MeSH terms:
Sick Sinus Syndrome
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Block
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014