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REducing 30-day ADMIssions in posT-discharge Subjects (READMIT) (READMIT-HF)

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ClinicalTrials.gov Identifier: NCT01574144
Recruitment Status : Completed
First Posted : April 10, 2012
Results First Posted : October 29, 2018
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Acute Decompensated Heart Failure
Intervention Device: AVIVO™ PiiX Patch Monitor System
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AVIVO™ PiiX Patch Monitor System
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Heart failure patients monitored continuously for 30 days post-discharge.

AVIVO™ PiiX Patch Monitor System: External monitoring for 30 days post-discharge.

Period Title: Overall Study
Started 70
Completed 70
Not Completed 0
Arm/Group Title AVIVO™ PiiX Patch Monitor System
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Heart failure patients monitored continuously for 30 days post-discharge.

AVIVO™ PiiX Patch Monitor System: External monitoring for 30 days post-discharge.

Overall Number of Baseline Participants 70
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All enrollment
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 70 participants
65.2  (13.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants
Female
28
  40.0%
Male
42
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 70 participants
United States 60
Australia 10
1.Primary Outcome
Title Percentage of Participants With Health Care Utilizations
Hide Description Percentage of Participants with health care utilizations. Healthcare utilizations include hospitalizations, urgent care visits and emergency department visits.
Time Frame 30 days post-discharge
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title AVIVO™ PiiX Patch Monitor System
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Heart failure patients monitored continuously for 30 days post-discharge.

AVIVO™ PiiX Patch Monitor System: External monitoring for 30 days post-discharge.

Overall Number of Participants Analyzed 70
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent
28.6
(18.4 to 40.6)
2.Secondary Outcome
Title Change in Body Weight Per Unit Change in Thoracic Impedance
Hide Description Change in body weight per unit change in thoracic impedance. The regression coefficients between body weight and thoracic impedance.
Time Frame Discharge to 30 days post discharge
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Hide Analysis Population Description
All subjects with changes of body weight and impedance from discharge to 30 days post discharge.
Arm/Group Title Heart Failure Patients Monitored Continuously With AVIVO PiiX
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AVIVO™ PiiX Patch Monitor System: External monitoring from enrollment to discharge: regression coefficient
Overall Number of Participants Analyzed 54
Mean (95% Confidence Interval)
Unit of Measure: lbs/Ohm
-0.03
(-0.15 to 0.09)
Time Frame From enrollment to 3 months post-discharge
Adverse Event Reporting Description

An adverse event (AE) is considered a serious AE if it

  1. Lead to death OR
  2. Lead to a serious deterioration in subject's health (life threatening illness/injury, permanent impairment of body, hospitalization/prolonged, medical/surgical intervention to prevent the previously mentioned conditions) OR
  3. Lead to fetal distress/death/defect
 
Arm/Group Title AVIVO™ PiiX Patch Monitor System
Hide Arm/Group Description

Heart failure patients monitored continuously for 30 days post-discharge.

AVIVO™ PiiX Patch Monitor System: External monitoring for 30 days post-discharge.

All-Cause Mortality
AVIVO™ PiiX Patch Monitor System
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
AVIVO™ PiiX Patch Monitor System
Affected / at Risk (%) # Events
Total   14/70 (20.00%)    
Cardiac disorders   
Atrial Fribrillation *  1/70 (1.43%)  1
Cardiac Failure Acute *  1/70 (1.43%)  1
Cardiac Failure congrestive *  4/70 (5.71%)  4
Supraventricular Tachycardia *  1/70 (1.43%)  1
Metabolism and nutrition disorders   
HyperKalaemia *  1/70 (1.43%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia *  1/70 (1.43%)  1
Nervous system disorders   
Syncope *  2/70 (2.86%)  2
Psychiatric disorders   
Mental Status Changes *  2/70 (2.86%)  2
Renal and urinary disorders   
Renal Failure Chronic *  1/70 (1.43%)  1
Reproductive system and breast disorders   
Scrotal Oedema *  1/70 (1.43%)  1
Respiratory, thoracic and mediastinal disorders   
Chronic Obstructive Pulmonary Disease *  1/70 (1.43%)  1
Dyspnoea *  1/70 (1.43%)  1
Pulmonary Hypertension *  1/70 (1.43%)  1
Vascular disorders   
Arteriovenous Fistula *  1/70 (1.43%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
AVIVO™ PiiX Patch Monitor System
Affected / at Risk (%) # Events
Total   9/70 (12.86%)    
Cardiac disorders   
Cardiac Failure congestive *  3/70 (4.29%)  3
General disorders   
Application Site Bruise *  1/70 (1.43%)  1
Application Site Rash *  2/70 (2.86%)  2
Investigations   
Blood Thyroid Stimlating Hormone Increased *  1/70 (1.43%)  1
Renal and urinary disorders   
Dysuria *  1/70 (1.43%)  1
Renal Failure Acute *  1/70 (1.43%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Amy Lautenbach
Organization: Medtronic, Inc
Phone: 7633609163
EMail: amy.a.lautenbach@medtronic.com@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT01574144    
Other Study ID Numbers: READMIT-HF
First Submitted: April 3, 2012
First Posted: April 10, 2012
Results First Submitted: February 12, 2014
Results First Posted: October 29, 2018
Last Update Posted: October 29, 2018