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

NCT02027909 | Completed

• 1 other identifier: CRIPS
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Sinus Node Dysfunction

Keywords

Sinus Node Dysfunction

Outcome Measures

Primary Outcomes (1)

• symptom improvement

  Patient report symptoms by clinician interview and patient symptom questionnaire

  study duration of 9 mths

Secondary Outcomes (1)

• improvement seen on device interrogations and reported improvement of symptoms

  study duration of 9 mths

Study Arms (3)

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

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

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

Interventions

Reprogramming dual chamber pacemaker DEVICE

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

Also known as: Medtronic dual chamber pacemaker

Therapy group one; Therapy group three; Therapy group two

Eligibility Criteria

• Age: 60 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Arun Rao: lead
• Medtronic: collaborator

Study Sites (1)

Wellmont CVA Heart Institute

Kingsport, Tennessee, 37660, United States

Location

Related Publications (3)

• 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. doi: 10.1111/j.1540-8159.1994.tb02370.x. No abstract available.

  PMID: 7885929 BACKGROUND

• 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. doi: 10.1093/oxfordjournals.eurheartj.a060413.

  PMID: 7835358 BACKGROUND

• Oto MA, Muderrisoglu 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. doi: 10.1111/j.1540-8159.1991.tb04110.x.

  PMID: 1712957 BACKGROUND

MeSH Terms

Conditions

Sick Sinus Syndrome

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arun Rao, MD

  Wellmont CVA Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Arun Rao, MD. FACC

Study Record Dates

• First Submitted: December 31, 2013
• First Posted: January 6, 2014
• Study Start: November 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 25, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)