NCT01619800

The Effect of Blended Sensor Efficiency on Relieving the Heart's Inability to Increase Its Rate During Exercise

The impAct of Blended Sensor Optimization on resoLVing Chronotropic Incompetence: ABSOLVE CI

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Vivek Reddy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this trial is to test the effect/benefit of a FDA approved blended pacemaker sensor which responds only by comparing physical activity, heart rate, and breathing rate; compared to the accelerometer pacemaker sensor which respond only by comparing physical activity and the heart rate in patients whose heart is unable increase its heart rate according to increase physical activity or demand (Chronotropic Incompetence). Only one pacemaker family will be used in this clinical trial whereas the "out of box" configuration is the blended sensor which can also be made to act only as an accelerometer.

Detailed description

Objective: The goal of this trial is to test the impact of individualized blended sensor optimization on chronotropic response, compared with accelerometer use alone, in patients with chronotropic incompetence who are planned to undergo permanent pacemaker (PPM) implantation. Study Population: The study population will consist of patients who suffer from the heart's inability to increase its heart rate according to increased physical activity or demand (chronotropic incompetence). These patients are planned to undergo permanent pacemaker (PPM) implantation. PRIMARY ENDPOINT: Improvement in chronotropic competence as defined as an increase in age-predicted maximum heart rate (APMHR) which is defined as 220 beats per minute (bpm) minus patient's age in years. Age-predicted heart rate reserve (APMHR) defined as APMHR minus patient's heart rate at rest. Observe the maximal heart rate during exercise test with decrease in oxygen consumption at each stage and also at peak effort. SECONDARY ENDPOINT: 1. Quality of life. 2. Procedural safety as defined by the number of complications within 1week associated with the procedure.

Conditions

• Chronotropic Incompetence

Interventions

Type	Name	Description
DEVICE	Blended Sensor Optimization (BSO)	At wound check (POD#1 and 1 Week F/U), histograms from device interrogation obtained from patients in the BSO group are assessed, and these patients undergo optimization. A hall walk and stair climbing exercise will be performed and MV optimized using trending data to hit the following targets: HR at Rest: 60 HR upon slow walking: 100 HR upon brisk walking: 115-120 HR upon climbing stairs: 130-135 Patients will undergo optimization, and be instructed that their device may have been optimized.
DEVICE	Accelerometer Alone (AA)	Patients in the AA group will also undergo device interrogation, and will perform a hall walk and stair climbing exercise. Afterwards, these patients will undergo a sham optimization by placing the PPM interrogation laptop device over there pacemaker, and instructing the patients that their device may have been optimized.

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2012-06-14
• Last updated: 2017-04-18
• Results posted: 2015-03-02

Locations

1 site across 1 country: United States