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

• Sponsor: Arun Rao (Other)
• Overall Status: Completed
• CT.gov ID: NCT02027909
• Collaborator: Medtronic (Industry)
• Enrollment: 8
• Location: 1
• Duration (Months): 41
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sinus Node Dysfunction	Device: Reprogramming 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Unpublished Holter data from our center indicates that the ADL rate for most patients in our practice is between 50-70bpm rather than 95bpm.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.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 8 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: A Comparison of Rate Response Performance in Pacemaker Patients With an Indication of Sinus Node Dysfunction.
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. symptom improvement [study duration of 9 mths]

   Patient report symptoms by clinician interview and patient symptom questionnaire

Secondary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 95 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Wellmont CVA Heart Institute	Kingsport	Tennessee	United States	37660

Sponsors and Collaborators

• Arun Rao
• Medtronic

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Lau CP, Leung SK. Clinical usefulness of rate adaptive pacing systems: what should we assess? Pacing Clin Electrophysiol. 1994 Dec;17(12 Pt 1):2233-5.
• Lau CP, Tai YT, Leung WH, Wong CK, Lee P, Chung FL. Rate adaptive pacing in sick sinus syndrome: effects of pacing modes and intrinsic conduction on physiological responses, arrhythmias, symptomatology and quality of life. Eur Heart J. 1994 Nov;15(11):1445-55.
• Oto MA, Müderrisoglu H, Ozin MB, Korkmaz ME, Karamehmetoglu A, Oram A, Oram E, Ugurlu S. Quality of life in patients with rate responsive pacemakers: a randomized, cross-over study. Pacing Clin Electrophysiol. 1991 May;14(5 Pt 1):800-6.

• Responsible Party: Arun Rao, Arun Rao, MD. FACC, Wellmont CVA Heart Institute
• ClinicalTrials.gov Identifier: NCT02027909
• Other Study ID Numbers: CRIPS
• First Posted: Jan 6, 2014
• Last Update Posted: Apr 25, 2018
• Last Verified: Apr 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Arun Rao, Arun Rao, MD. FACC, Wellmont CVA Heart Institute: Sinus Node Dysfunction
• Additional relevant MeSH terms: Sick Sinus Syndrome

Study Results

No Results Posted as of Apr 25, 2018