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

Sinus Node Dysfunction Clinical Trial

— CRIPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02027909
• Other study ID #: CRIPS
• Status: Completed
• First received: December 31, 2013
• Last updated: April 23, 2018
• Start date: November 2011
• Est. completion date: April 2015

Study information

• Verified date: April 2018
• Source: Wellmont CVA Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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Unpublished Holter data from our center indicates that the ADL rate for most patients in our practice is between 50-70bpm rather than 95bpm.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 95 Years

Eligibility

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)

Related Conditions & MeSH terms

• Sick Sinus Syndrome
• Sinus Node Dysfunction

Intervention

Device:
• Reprogramming dual chamber pacemaker
Reprogramming rate response feature in the Medtronic pacemaker to each arm with crossover

Locations

Country	Name	City	State
United States	Wellmont CVA Heart Institute	Kingsport	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Arun Rao	Medtronic

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptom improvement	Patient report symptoms by clinician interview and patient symptom questionnaire	study duration of 9 mths
Secondary	improvement seen on device interrogations and reported improvement of symptoms	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