Trial Outcomes & Findings for APPROPRIATE - Rate Adaptive Pacing Sensor (NCT NCT00757666)

NCT ID: NCT00757666

Last Updated: 2017-06-14

Results Overview

The APPROPRIATE Study compared differences in functional capacity (peak VO2) between CI patients randomized to receive rate responsive pacing driven by either the minute ventilation (respiration-based) sensor or by an accelerometer (motion-based) sensor. The mean change in functional capactity will be compared against baseline; changes from baseline will be measured.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

566 participants

Primary outcome timeframe

1 month and 2 months post-implant

Results posted on

2017-06-14

Participant Flow

Participant milestones

Participant milestones
Measure	Accelerometer Accelerometer	Minute Ventilation Minute ventilation
Overall Study STARTED	34	34
Overall Study COMPLETED	12	11
Overall Study NOT COMPLETED	22	23

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

APPROPRIATE - Rate Adaptive Pacing Sensor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Accelerometer n=34 Participants Accelerometer	Minute Ventilation n=34 Participants Minute ventilation	Total n=68 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=39 Participants	7 Participants n=41 Participants	15 Participants n=35 Participants
Age, Categorical >=65 years	26 Participants n=39 Participants	27 Participants n=41 Participants	53 Participants n=35 Participants
Age, Continuous	70.0 years STANDARD_DEVIATION 8.4 • n=39 Participants	70.7 years STANDARD_DEVIATION 8.2 • n=41 Participants	70.4 years STANDARD_DEVIATION 8.2 • n=35 Participants
Sex: Female, Male Female	13 Participants n=39 Participants	16 Participants n=41 Participants	29 Participants n=35 Participants
Sex: Female, Male Male	21 Participants n=39 Participants	18 Participants n=41 Participants	39 Participants n=35 Participants
Region of Enrollment United States	34 participants n=39 Participants	34 participants n=41 Participants	68 participants n=35 Participants

PRIMARY outcome

Timeframe: 1 month and 2 months post-implant

Population: Data was not analyzed since patient enrollment was ceased and study was prematurely terminated.

The APPROPRIATE Study compared differences in functional capacity (peak VO2) between CI patients randomized to receive rate responsive pacing driven by either the minute ventilation (respiration-based) sensor or by an accelerometer (motion-based) sensor. The mean change in functional capactity will be compared against baseline; changes from baseline will be measured.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 months post-implant

Population: Data was not analyzed since patient enrollment was ceased and study was prematurely terminated.

This outcome measure will be compared against baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 month and 2 months post-implant

Population: Data was not analyzed since patient enrollment was ceased and study was prematurely terminated.

Outcome measures

Outcome measures
Measure	Minute Ventilation	Accelerometer
Metabolic Chronotropic Relationship (MCR) Slope	0	0

SECONDARY outcome

Timeframe: 1 month and 2 months post-implant

Population: Data was not analyzed since patient enrollment was ceased and study was prematurely terminated.

Outcome measures

Outcome measures
Measure	Minute Ventilation	Accelerometer
Exercise Time	0	0

SECONDARY outcome

Timeframe: 1 month and 2 months post-implant

Population: Data was not analyzed since patient enrollment was ceased and study was prematurely terminated.

Outcome measures

Outcome measures
Measure	Minute Ventilation	Accelerometer
VO2 at Ventilatory Threshold	0	0

Adverse Events

Accelerometer

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Minute Ventilation

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Accelerometer n=34 participants at risk Accelerometer	Minute Ventilation n=34 participants at risk Minute ventilation
Cardiac disorders Cardiovascular Adverse Events	17.6% 6/34	23.5% 8/34

Additional Information

Director of Clinical Affairs

Boston Scientific

Phone: 651-582-2277

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The first publication of the results shall be made a joint, multi-center publication.
Publication restrictions are in place

Restriction type: OTHER