Trial Outcomes & Findings for TRUST: Lumos-T Safely RedUceS RouTine Office Device Follow-up (NCT NCT00336284)

Last Updated: 2010-08-03

Results Overview

Average number of office-based implantable cardioverter defibrillator (ICD) follow-up visits in the Home Monitoring arm vs the Conventional (calendar-based) follow-up arm.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1450 participants

Primary outcome timeframe

12 months

Results posted on

2010-08-03

Participant Flow

Participant milestones

Participant milestones
Measure	Home Monitoring Home Monitoring programmed ON	Conventional Home Monitoring programmed OFF
Overall Study STARTED	977	473
Overall Study COMPLETED	741	322
Overall Study NOT COMPLETED	236	151

Reasons for withdrawal

Reasons for withdrawal
Measure	Home Monitoring Home Monitoring programmed ON	Conventional Home Monitoring programmed OFF
Overall Study Death	52	26
Overall Study Lost to Follow-up	82	61
Overall Study Withdrawal by Physician or Subject	102	64

Baseline Characteristics

TRUST: Lumos-T Safely RedUceS RouTine Office Device Follow-up

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Home Monitoring n=908 Participants Home Monitoring programmed ON	Conventional n=431 Participants Home Monitoring programmed OFF	Total n=1339 Participants Total of all reporting groups
Age Continuous	63 years STANDARD_DEVIATION 13 • n=5 Participants	64 years STANDARD_DEVIATION 12 • n=7 Participants	64 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	254 Participants n=5 Participants	116 Participants n=7 Participants	370 Participants n=5 Participants
Sex: Female, Male Male	654 Participants n=5 Participants	315 Participants n=7 Participants	969 Participants n=5 Participants
Region of Enrollment United States	896 participants n=5 Participants	425 participants n=7 Participants	1321 participants n=5 Participants
Region of Enrollment Canada	12 participants n=5 Participants	6 participants n=7 Participants	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Only participants who completed at least one follow-up visit are included in the analyses.

Average number of office-based implantable cardioverter defibrillator (ICD) follow-up visits in the Home Monitoring arm vs the Conventional (calendar-based) follow-up arm.

Outcome measures

Outcome measures
Measure	Home Monitoring n=908 Participants Home Monitoring programmed ON	Conventional n=431 Participants Home Monitoring programmed OFF
Home Monitoring Effectiveness	2.1 In-office ICD follow-up per patient year Interval 0.0 to 45.6	3.8 In-office ICD follow-up per patient year Interval 0.0 to 19.2

PRIMARY outcome

Timeframe: 12 months

Population: Safety Event Rate includes events occuring within 12 months of enrollment for participants with at least 1 follow-up.

Percentage of participants experiencing death, incidence of stroke, or event(s) requiring surgical intervention. Outcome measure time frame is 12 months.

Outcome measures

Outcome measures
Measure	Home Monitoring n=908 Participants Home Monitoring programmed ON	Conventional n=431 Participants Home Monitoring programmed OFF
Percent of Participants Experiencing Death, Incidence of Stroke, or Event Requiring Surgical Intervention.	10.4 Percentage of participants	10.4 Percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Only participants with at least one follow-up are included in the analyses.

Detection time relative to onset of cardiac events (atrial fibrillation, ventricular tachycardia, ventricular fibrillation).

Outcome measures

Outcome measures
Measure	Home Monitoring n=908 Participants Home Monitoring programmed ON	Conventional n=431 Participants Home Monitoring programmed OFF
Early Detection of Cardiac Events	13.98 Days Interval 0.0 to 256.0	45.34 Days Interval 0.0 to 287.0

SECONDARY outcome

Timeframe: 12 months

Population: Only participants with at least one follow-up are included in the analyses

Percentage of total patient initiated inqueries that result in ER or office follow-up visits.

Outcome measures

Outcome measures
Measure	Home Monitoring n=908 Participants Home Monitoring programmed ON	Conventional n=431 Participants Home Monitoring programmed OFF
Patient Initiated Follow-up	92.7 percent of patient initiated follow-ups	100 percent of patient initiated follow-ups

Adverse Events

Home Monitoring

Serious events: 124 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional

Serious events: 74 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Justin Michalski, M.S. / Clinical Studies Engineer

Biotronik, Inc.

Phone: 503-675-2155

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator agrees to provide copies of any abstracts, papers or manuscripts to the Sponsor for review within a reasonable period prior to submittal for publication. BIOTRONIK limits its review to a determination of whether Confidential Information (CI) is disclosed and may not attempt to censor or in any way interfere with the investigator's presentation or conclusions beyond the extent necessary to protect CI or to allow to protect its rights in patentable or copyrightable material.
Publication restrictions are in place

Restriction type: OTHER

Measure	Home Monitoring n=977 participants at risk Home Monitoring programmed ON	Conventional n=473 participants at risk Home Monitoring programmed OFF
Surgical and medical procedures Ablation procedure	0.51% 5/977 • Number of events 5 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.	0.85% 4/473 • Number of events 4 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.
Surgical and medical procedures Aborted upgrade procedure	0.00% 0/977 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.	0.21% 1/473 • Number of events 1 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.
Cardiac disorders Cardiac related hospitalizations	4.6% 45/977 • Number of events 64 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.	6.6% 31/473 • Number of events 35 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.
Surgical and medical procedures Catheterization/PCI procedure	1.5% 15/977 • Number of events 16 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.	0.63% 3/473 • Number of events 4 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.
Surgical and medical procedures Coronary artery bypass graft procedure	0.31% 3/977 • Number of events 3 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.	0.00% 0/473 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.
General disorders Death	5.3% 52/977 • Number of events 52 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.	5.5% 26/473 • Number of events 26 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.
Surgical and medical procedures Device change-out	0.82% 8/977 • Number of events 8 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.	0.63% 3/473 • Number of events 3 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.
Surgical and medical procedures Device revision	1.7% 17/977 • Number of events 18 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.	1.5% 7/473 • Number of events 7 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.
Surgical and medical procedures Heart transplant	0.10% 1/977 • Number of events 1 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.	0.00% 0/473 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.
Surgical and medical procedures IVC filter implanted	0.10% 1/977 • Number of events 1 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.	0.00% 0/473 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.
Surgical and medical procedures LV assist device implanted	0.10% 1/977 • Number of events 1 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.	0.00% 0/473 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.
Surgical and medical procedures Lead revision/explant/replacement	1.6% 16/977 • Number of events 16 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.	1.1% 5/473 • Number of events 5 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.
General disorders Non-cardiac related hospitalizations	1.6% 16/977 • Number of events 20 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.	0.63% 3/473 • Number of events 4 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.
Surgical and medical procedures Non-cardiac surgical interventions	0.72% 7/977 • Number of events 8 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.	0.63% 3/473 • Number of events 4 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.
Surgical and medical procedures Permacath for dialysis and endoscopy	0.10% 1/977 • Number of events 1 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.	0.00% 0/473 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.
Surgical and medical procedures Tighten loose set screw	0.00% 0/977 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.	0.21% 1/473 • Number of events 1 • 15 Months Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.