The Effect of Blended Sensor Efficiency on Relieving the Heart's Inability to Increase Its Rate During Exercise (ABSOLVE CI)
|Chronotropic Incompetence||Device: Blended Sensor Optimization (BSO) Device: Accelerometer Alone (AA)|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Supportive Care
|Official Title:||The impAct of Blended Sensor Optimization on resoLVing Chronotropic Incompetence: ABSOLVE CI|
- Changed in Stress Test at 6 Months as Compared to Baseline [ Time Frame: baseline and 6 months ]An Exercise or Dobumatime Stress Test to be performed to assess primary outcome measure.
|Study Start Date:||March 2012|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: Blended Sensor Optimization (BSO)
Patients in this arm will undergo pacemaker placement and will have blended sensor optimization. Minute Ventilation will be optimized/activated
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.
Sham Comparator: Accelerometer Alone (AA)
Patients in this arm will undergo pacemaker implantation but will not have Minute Ventilation Sensor activated. Only accelerometer will remain active
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.
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.
- Quality of life.
- Procedural safety as defined by the number of complications within 1week associated with the procedure.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619800
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Vivek Reddy, MD||Icahn School of Medicine at Mount Sinai|