Trial Outcomes & Findings for Sensitivity of the InSync Sentry OptiVol Feature for the Prediction of Heart Failure (NCT NCT00400985)

Last Updated: 2025-07-02

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

501 participants

Primary outcome timeframe

34 days post device implant to 6 months

Results posted on

2025-07-02

501 patients from 41 medical clinics in 13 countries were enrolled between March 4, 2005 and September 9, 2008.

Participant milestones
Measure	All Patients All study participants received the same treatment
Overall Study STARTED	501
Overall Study COMPLETED	449
Overall Study NOT COMPLETED	52

Reasons for withdrawal
Measure	All Patients All study participants received the same treatment
Overall Study Withdrawal by Subject	5
Overall Study system modification	8
Overall Study Death	30
Overall Study Lost to Follow-up	9

Sensitivity of the InSync Sentry OptiVol Feature for the Prediction of Heart Failure

Baseline characteristics by cohort
Measure	Group 1 n=501 Participants
Cronic Heart Failure (CHF) patients with a Cardiac Resynchronization Therapy device system	501 participants n=5 Participants
Age, Continuous	65 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	79 Participants n=5 Participants
Sex: Female, Male Male	422 Participants n=5 Participants
Region of Enrollment Belgium	44 participants n=5 Participants
Region of Enrollment United Kingdom	38 participants n=5 Participants
Region of Enrollment Germany	70 participants n=5 Participants
Region of Enrollment Italy	115 participants n=5 Participants
Region of Enrollment France	58 participants n=5 Participants
Region of Enrollment Greece	38 participants n=5 Participants
Region of Enrollment Israel	29 participants n=5 Participants
Region of Enrollment Spain	23 participants n=5 Participants
Region of Enrollment Slovakia	22 participants n=5 Participants
Region of Enrollment Denmark	21 participants n=5 Participants
Region of Enrollment Czech Republic	19 participants n=5 Participants
Region of Enrollment Poland	18 participants n=5 Participants
Region of Enrollment China	6 participants n=5 Participants
Device therapy CRT-D	393 units n=5 Participants
Device therapy ICD	108 units n=5 Participants

Timeframe: 34 days post device implant to 6 months

Outcome measures
Measure	All Patients n=501 Participants All patients received the same treatment
Prediction by OptiVol of HF-related Hospitalizations With Signs and/or Symptoms of Pulmonary Congestion.	58 hospitalization

Serious events: 42 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events
Measure	Group 1 n=501 participants at risk
Cardiac disorders HF related hospitalization	8.4% 42/501 • Number of events 58

Other adverse events
Measure	Group 1 n=501 participants at risk
Cardiac disorders Heart Failure decompensation	10.4% 52/501 • Number of events 104

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