Trial Outcomes & Findings for The Effect of Blended Sensor Efficiency on Relieving the Heart's Inability to Increase Its Rate During Exercise (NCT NCT01619800)

Results Overview

An Exercise or Dobumatime Stress Test to be performed to assess primary outcome measure.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

baseline and 6 months

Results posted on

2017-04-18

Participant milestones
Measure	Blended Sensor Optimization (BSO) Patients in this arm will undergo pacemaker placement and will have blended sensor optimization. Minute Ventilation will be optimized/activated	Accelerometer Alone (AA) Patients in this arm will undergo pacemaker implantation but will not have Minute Ventilation Sensor activated. Only accelerometer will remain active
Overall Study STARTED	2	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal
Measure	Blended Sensor Optimization (BSO) Patients in this arm will undergo pacemaker placement and will have blended sensor optimization. Minute Ventilation will be optimized/activated	Accelerometer Alone (AA) Patients in this arm will undergo pacemaker implantation but will not have Minute Ventilation Sensor activated. Only accelerometer will remain active
Overall Study study terminated	2	0

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

Baseline characteristics by cohort
Measure	Blended Sensor Optimization (BSO) n=2 Participants Patients in this arm will undergo pacemaker placement and will have blended sensor optimization. Minute Ventilation will be optimized/activated	Accelerometer Alone (AA) Patients in this arm will undergo pacemaker implantation but will not have Minute Ventilation Sensor activated. Only accelerometer will remain active	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	—	0 Participants n=5 Participants

Timeframe: baseline and 6 months

An Exercise or Dobumatime Stress Test to be performed to assess primary outcome measure.

Outcome data not reported

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Icahn School of Medicine at Mount Sinai

Phone: 212-241-7114