Comparison of Physiologic Response With Rate Adaptive Pacing Driven by Minute Ventilation and Accelerometer — RAP  

Chronotropic Incompetence Clinical Trial

Official title: Comparison of Physiologic Response With Rate Adaptive Pacing Driven by Minute Ventilation and Accelerometer

Status Recruiting

Clinical Trial Summary

Some patients' heart rates do not increase as needed during activities and exercise, which can make them feel tired and fatigued easily. The patients in this study have a pacemaker with a FDA approved rate response sensor, which senses activity level by sensing motion (through a component known as an accelerometer) and/or breathing changes (known as minute ventilation). These changes in motion or breathing make the pacemaker increase the patient's heart rate. This study is being conducted to see which rate response sensor is better (motion driven or breathing driven). The study is also investigating whether optimizing the sensor based on the individual patient will give better results in terms of increasing the patient's exercise capacity. The hypothesis is that rate responsive pacing driven by the minute ventilation sensor results in improved functional capacity compared to accelerometer in chronotropically incompetent patients.

Clinical Trial Description

This study is a double-blind, randomized, two-arm (with crossover to other arm) trial that will investigate the benefit of rate responsive pacing with either MV or XL in pacemaker patients that have chronotropic incompetence (CI). Blinding will occur for both the patient and the research personnel who are collecting primary endpoint data. The study will enroll patients that have an implanted dual/single chamber pacemaker, which has both the minute ventilation (MV) and accelerometer (XL) rate-adaptive sensors.

The initial study visit called as baseline visit for newly implanted patients (at 2 weeks from implant) and for previously implanted patients (at the time of enrolling in the study).

Patients will complete a 6-min walk test at the baseline study visit to screen for CI based on the intrinsic heart rate achieved during the walk while pacemaker set to DDD/VVI with both sensors set to passive. All patients that are enrolled in the study will get treadmill exercise stress test by chronotropic assessment exercise protocol (CAEP) to confirm CI. Patients will be determined to have CI by completing a maximal effort exercise treadmill stress test with peak perceived exertion by Borg scale of >16 (18) with the pacemaker programmed to DDD/VVI with both device sensors set to passive. Patients that do not meet the criteria of CI after CAEP treadmill test will not continue in the trial.

Patients that have CI will then be randomized in a 1:1 ratio to programming the rate-adaptive sensor to either MV or XL. The MV or XL rate-adaptive sensor will be optimized for each patient using stress test derived age predicted maximum heart rate by adjusting response factor to achieve MCR slope of 1.

At the 4-week visit, patients that have CI will complete a second CAEP treadmill test in their randomized setting with pacer set as DDDR/VVIR. They will also complete 6-minute walk test and pacemaker interrogation. They will be crossed over to the other sensor group at this time by changing the sensor setting.

At 8 week visit, patients will have another CAEP treadmill test, 6-minute walk test and pacemaker interrogation in their randomized crossed over group setting.

Patients that have CI will get quality of life assessment using SF-36 questionnaire and Aquarel questionnaire at baseline visit, 4 and 8 week visit in their randomized setting. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronotropic Incompetence

• NCT number: NCT02003378
• Study type: Interventional
• Source: Albany Medical College
• Contact: Wendy Stewart, MS
• Phone: 518-262-9316
• Email: stewarw@mail.amc.edu
• Status: Recruiting
• Phase: N/A
• Start date: September 2013
• Completion date: June 2014