N/A
Completed N=1,997
CONNECT Study - Clinical Evaluation Of Remote NotificatioN to rEduCe Time to Clinical Decision
Source: ClinicalTrials.gov NCT00402246 ↗Enrolled (actual)
1,997
Serious AEs
—
Results posted
Feb 2011
Primary outcomePrimary: Time Per Patient From a Clinical Event to a Clinical Decision in Response to Arrhythmias, Cardiovascular (CV) Disease Progression, and Device Issues — 4.6; 22.0 days — p=<0.001
Summary
The purpose of this study is to determine whether the ability of clinicians to receive and review information from patients implanted with a heart device over the internet (remote care) is comparable to patients who are seen in-office for routine visits to check the status of their device.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Per Patient From a Clinical Event to a Clinical Decision in Response to Arrhythmias, Cardiovascular (CV) Disease Progression, and Device Issues |
4.6; 22.0 | <0.001 sig |
| SECONDARY Health Care Utilization (HCU) |
567; 508; 270; 223; 2545; 2114 | 0.524 |
| SECONDARY Health Care Utilization: TEEs |
26; 17 | 0.29 |
| SECONDARY Actions Taken for HCU Visits |
3869; 2895; 687; 513; 26; 17 | — |
| SECONDARY Clinically Meaningful Alerts |
238 | — |
| SECONDARY Symptomatic AT/AF Alerts |
73 | — |
| SECONDARY AT/AF Alert Treatment |
159; 2; 23; 89; 30 | — |
| SECONDARY Time Per Patient From a Clinical Event Onset to a Clinical Decision for Symptom-driven Device Interrogations |
0.8; 0.7 | 0.779 |
| SECONDARY Time Per Patient From a Clinical Event Onset to a Clinical Decision for Both Device Events and Symptom-driven Device Interrogations |
6.7; 16.7 | <0.001 sig |
| SECONDARY CareLink Transmission Compliance |
0.761; 0.815; 0.815; 0.814 | — |
| SECONDARY Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM) |
0.181; 0.117; 0.118; 0.121; 0.132; 0.135 | — |
| SECONDARY State-Anxiety Scale |
31.0; 32.1; 30.3; 31.6; 30.0; 30.7 | 0.217 |
| SECONDARY Trait-Anxiety Scale |
31.2; 32.1; 29.8; 31.3; 29.6; 30.8 | 0.154 |
| SECONDARY Clinic Personnel Satisfaction With Wireless Telemetry (Telemetry + Leadless ECG). |
4.3; 4.0; 3.8; 4.2; 4.0; 3.9 | — |
| SECONDARY In-office Follow-up Burden: Distance Traveled |
49.2 | — |
| SECONDARY In-office Follow-up Burden: Patient Expenses |
15.0 | — |
| SECONDARY In-office Follow-up Burden: Hours Absent From Work Due to Visit |
4.4 | — |
Eligibility Criteria
Inclusion Criteria
- Patient will be implanted with a Medtronic Conexus-enabled Cardiac Resynchronization Therapy Defibrillator (CRT-D) or Implantable Cardioverter-Defibrillator (DR-ICD) device.
Exclusion Criteria
- Patient has permanent rapid beats in the upper chamber of the heart (Atrial Fibrillation) - (constant atrial fibrillation in which pharmacological therapy or cardioversion failed or not attempted).
- Patient plans to be on chronic warfarin therapy post-implant and is no longer receiving therapies to attempt to control the rhythm of the beats in their atrium.
- Patient has a previous ICD, CRT-D, Implantable Pulse Generator (IPG) or Cardiac Resynchronization Therapy Pacemaker (CRT-P).
Data sourced from ClinicalTrials.gov (NCT00402246). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.