Trial Outcomes & Findings for TRIAGE-CRT Telemonitoring in Patients With CHF and Indication of CRT-D (NCT NCT00395642)

Results Overview

Analyzed transmission periods for weight, blood pressure (BP) and Home Monitoring (HM) started with the respective first transmission. In patients where neither system transmitted data, the date of enrollment was taken as the start date of the analyzed period for all systems. If only one remote system transmitted data (e.g. HM or weight and BP data only), the first transmission date from the corresponding, successfully transmitting system was assumed as the start date of the analyzed period for the non-transmitting system. Analyzed transmission period ended with study exit or completion.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

66 participants

Primary outcome timeframe

6 months

Results posted on

2010-01-20

Participant Flow

Participant milestones

Participant milestones
Measure	Home Monitoring With Weight and BP Remote Monitoring Device based Home Monitoring with weight and blood pressure (BP) remote monitoring
Overall Study STARTED	66
Overall Study COMPLETED	53
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Home Monitoring With Weight and BP Remote Monitoring Device based Home Monitoring with weight and blood pressure (BP) remote monitoring
Overall Study Death	4
Overall Study Lost to Follow-up	1
Overall Study Physician Decision	7
Overall Study Withdrawal by Subject	1

Baseline Characteristics

TRIAGE-CRT Telemonitoring in Patients With CHF and Indication of CRT-D

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Home Monitoring With Weight and BP Remote Monitoring n=66 Participants Device based Home Monitoring with weight and blood pressure (BP) remote monitoring
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=5 Participants
Age, Categorical >=65 years	29 Participants n=5 Participants
Age Continuous	65 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants
Region of Enrollment United States	66 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: All Enrolled Participants

Analyzed transmission periods for weight, blood pressure (BP) and Home Monitoring (HM) started with the respective first transmission. In patients where neither system transmitted data, the date of enrollment was taken as the start date of the analyzed period for all systems. If only one remote system transmitted data (e.g. HM or weight and BP data only), the first transmission date from the corresponding, successfully transmitting system was assumed as the start date of the analyzed period for the non-transmitting system. Analyzed transmission period ended with study exit or completion.

Outcome measures

Outcome measures
Measure	Home Monitoring With Weight and BP Remote Monitoring n=66 Participants Device based Home Monitoring with weight and blood pressure (BP) remote monitoring
Patient Compliance of Weight and Blood Pressure External Monitoring and Home Monitoring Transmissions. Percentage of Days Transmitted. Weight Telemonitoring	71 Percent of days
Patient Compliance of Weight and Blood Pressure External Monitoring and Home Monitoring Transmissions. Percentage of Days Transmitted. BP Telemonitoring	71 Percent of days
Patient Compliance of Weight and Blood Pressure External Monitoring and Home Monitoring Transmissions. Percentage of Days Transmitted. HM System	83 Percent of days

Adverse Events

Home Monitoring With Weight and BP Remote Monitoring

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Home Monitoring With Weight and BP Remote Monitoring n=66 participants at risk Device based Home Monitoring with weight and blood pressure (BP) remote monitoring
Cardiac disorders Heart Failure related Hospitalization	9.1% 6/66 • Number of events 9
General disorders Death	6.1% 4/66 • Number of events 4
Cardiac disorders Complication	4.5% 3/66 • Number of events 4

Additional Information

Katerina de Metz (Director, Clinical Studies)

BIOTRONIK, Inc.

Phone: 800-547-0394

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator agrees to submit copies of any proposed publication to Sponsor for review at least 30 days in advance of submission for publication or presentation. Sponsor may delete any Confidential Information or other proprietary information. In addition, Sponsor may extend such review period for another 90 days to file patent applications or take other steps to protect its intellectual property interests.
Publication restrictions are in place

Restriction type: OTHER