Key Results
Key Result 1
At 12 months follow-up, significantly fewer patients in the BIOTRONIK Home Monitoring® group worsened according to the modified Packer score compared to the control group (18.9% vs27.5%; p<0.05).
IN-TIME Clinical Trial
Influence of Home Monitoring on the Clinical Status of Heart Failure Patients
Hindricks et al., The Lancet 2014
Study Design
- Randomized, controlled, international, multicenter study
- Assesses the impact of BIOTRONIK Home Monitoring® on the clinical status of heart failure patients
- 664 patients at 36 centers
Key Result 2
Significant reduction of all-cause mortality in heart failure patients of more than 60% and beneficial effect on the composite clinical score with implant-based (ICD or CRT-D) BIOTRONIK Home Monitoring® compared to standard care.
Clinical Relevance
- The IN-TIME study demonstrated improved clinical status for heart failure patients by implementing a remote monitoring system based on:
- A reliable transmission rate of 85%
- A clinically relevant set of rhythmological and technical parameters
- Clinical workflow that enables fast patient contact and follow-up within one to two working days
Study Details
Study Objective
- Assessment of the impact of BIOTRONIK Home Monitoring® on the clinical status of heart failure patients
Primary Endpoint
- Modified Packer score: based on death, hospitalization, change in NYHA class, patient’s global self-assessment score
Major Secondary Endpoints
- All–cause mortality
- Number of HF hospitalizations and length(s) of stay
Clinical Sites
- 36 centers (Australia, Austria, Czech Republic, Denmark, Germany, Israel and Latvia)
Sample Size
- 664 patients
Main Inclusion Criteria
- ICD indication (dual-chamber ICD, CRT-D)
- Chronic heart failure
- NYHA class II or III
- LVEF ≤ 35%
Main Exclusion Criteria
- Permanent atrial fibrillation
Devices
- ICD and CRT-D
Study Flowchart
Follow-Up
- 12 months after randomization
Study Duration
- July 2007 - December 2010
Reference no.
- NCT00538356
Principal Investigators
- Prof. Dr. Gerhard Hindricks, Herzzentrum Leipzig, Germany