Back to resultsEvaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device (CLEPSYDRA)
Primary Purpose
Congestive Heart Failure
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Paradym CRT + Physiological Diagnosis (PhD)
Sponsored by
About this trial
This is an interventional diagnostic trial for Congestive Heart Failure focused on measuring NYHA Class III or IV, Implantable Cardiac Defibrillator, Cardiac Resynchronization Therapy
Eligibility Criteria
Inclusion Criteria:
- Subject eligible for implantation of a CRT-D device according to current available guidelines for cardiac resynchronization therapy
- Subject has severe heart failure (NYHA Class III or IV)
- Subject has experienced at least one heart failure event within six months prior to enrollment
- Subject continues to have heart failure symptoms despite receiving optimal medical therapy
- Schedule for implant of a PARADYM CRT-D (Model 8770)
- Subject has signed and dated an informed consent form
Exclusion Criteria:
- Any contraindication for standard cardiac pacing
- Any contraindication for ICD therapy
- Abdominal implantation site
- Hypertrophic or obstructive cardiomyopathy
- Acute myocarditis
- Unstable coronary symptoms (unstable angina or myocardial infarction) within the last month
- Recent (within the last month) or planned cardiac revascularization or coronary angioplasty
- Correctable valvular disease that is the primary cause of heart failure
- Mechanical tricuspid valve
- Receiving continuous intra-venous infusion of positive inotropic therapy or intermittent therapy (intravenous infusion) more than twice per week
- Heart transplant recipient
- Renal insufficiency requiring dialysis
- Already included in another clinical study
- Life expectancy less than 12 months
- Inability to understand the purpose of the study or refusal to cooperate
- Inability or refusal to provide informed consent or HIPAA
- Unavailability for scheduled follow-up at the implanting center
- Known sensitivity to 1mg dexamethasone sodium phosphate (DSP)
- Under guardianship
- Age of less than 18 years
- Pregnancy
Sites / Locations
- Mountain Vista Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CRT Therapy
Arm Description
All patients will receive CRT therapy with the Physiological Diagnosis (PhD) feature enabled.
Outcomes
Primary Outcome Measures
Sensitivity of diagnostic feature in detecting heart failure events (using the device) in comparison to clinical heart failure events experienced by the patient (as classified by an independent committee).
Mean number of false positives per patient per year.
Secondary Outcome Measures
Full Information
NCT ID
NCT00957541
First Posted
August 10, 2009
Last Updated
May 14, 2014
Sponsor
ELA Medical, Inc.
Collaborators
LivaNova
1. Study Identification
Unique Protocol Identification Number
NCT00957541
Brief Title
Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device
Acronym
CLEPSYDRA
Official Title
Clinical Evaluation of the Physiological Diagnosis Function in the Paradym CRT Device
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ELA Medical, Inc.
Collaborators
LivaNova
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, which has been implemented in a cardiac resynchronization therapy (CRT) device. This trial will study the effectiveness of the diagnostic feature to detect heart failure events in medically stable, ICD-indicated, congestive heart failure patients.
Detailed Description
The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, which has been implemented in a cardiac resynchronization therapy (CRT) device. This trial will study the effectiveness of the diagnostic feature to detect heart failure events in medically stable, ICD-indicated, congestive heart failure patients. The ability of the diagnostic feature to 'detect' and 'predict' heart failure events will be studied.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
NYHA Class III or IV, Implantable Cardiac Defibrillator, Cardiac Resynchronization Therapy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Non-Randomized
Enrollment
520 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CRT Therapy
Arm Type
Experimental
Arm Description
All patients will receive CRT therapy with the Physiological Diagnosis (PhD) feature enabled.
Intervention Type
Device
Intervention Name(s)
Paradym CRT + Physiological Diagnosis (PhD)
Intervention Description
All subjects will undergo CRT therapy with the Physiological Diagnosis (PhD) feature enabled.
Primary Outcome Measure Information:
Title
Sensitivity of diagnostic feature in detecting heart failure events (using the device) in comparison to clinical heart failure events experienced by the patient (as classified by an independent committee).
Time Frame
Thirteen months
Title
Mean number of false positives per patient per year.
Time Frame
Thirteen Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject eligible for implantation of a CRT-D device according to current available guidelines for cardiac resynchronization therapy
Subject has severe heart failure (NYHA Class III or IV)
Subject has experienced at least one heart failure event within six months prior to enrollment
Subject continues to have heart failure symptoms despite receiving optimal medical therapy
Schedule for implant of a PARADYM CRT-D (Model 8770)
Subject has signed and dated an informed consent form
Exclusion Criteria:
Any contraindication for standard cardiac pacing
Any contraindication for ICD therapy
Abdominal implantation site
Hypertrophic or obstructive cardiomyopathy
Acute myocarditis
Unstable coronary symptoms (unstable angina or myocardial infarction) within the last month
Recent (within the last month) or planned cardiac revascularization or coronary angioplasty
Correctable valvular disease that is the primary cause of heart failure
Mechanical tricuspid valve
Receiving continuous intra-venous infusion of positive inotropic therapy or intermittent therapy (intravenous infusion) more than twice per week
Heart transplant recipient
Renal insufficiency requiring dialysis
Already included in another clinical study
Life expectancy less than 12 months
Inability to understand the purpose of the study or refusal to cooperate
Inability or refusal to provide informed consent or HIPAA
Unavailability for scheduled follow-up at the implanting center
Known sensitivity to 1mg dexamethasone sodium phosphate (DSP)
Under guardianship
Age of less than 18 years
Pregnancy
Facility Information:
Facility Name
Mountain Vista Hospital
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85209
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20947571
Citation
Auricchio A, Brugada J, Ellenbogen KA, Gold MR, Leyva F; CLEPSYDRA investigators. Assessment of a novel device-based diagnostic algorithm to monitor patient status in moderate-to-severe heart failure: rationale and design of the CLEPSYDRA study. Eur J Heart Fail. 2010 Dec;12(12):1363-71. doi: 10.1093/eurjhf/hfq170. Epub 2010 Oct 14.
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Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device
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