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

Arun Rao

Status: Completed

Conditions: Sinus Node Dysfunction

Treatments: Device: Reprogramming dual chamber pacemaker

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02027909

CRIPS

Details and patient eligibility

About

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.

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Unpublished Holter data from our center indicates that the ADL rate for most patients in our practice is between 50-70bpm rather than 95bpm.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

Enrollment: 8 patients

Sex: All

Ages: 60 to 95 years old

Volunteers: No Healthy Volunteers

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)

Trial design

8 participants in 3 patient groups

Therapy group one

Description:

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.

Treatment:

Device: Reprogramming dual chamber pacemaker

Therapy group two

Description:

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.

Treatment:

Device: Reprogramming dual chamber pacemaker

Therapy group three

Description:

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.

Treatment:

Device: Reprogramming dual chamber pacemaker