Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device

Congestive Heart Failure Clinical Trial

— CLEPSYDRA  

Official title:

Clinical Evaluation of the Physiological Diagnosis Function in the Paradym CRT Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00957541
• Other study ID #: ITSY02
• Status: Completed
• Phase: Phase 2
• First received: August 10, 2009
• Last updated: May 14, 2014
• Start date: September 2009
• Est. completion date: April 2013

Study information

• Verified date: May 2014
• Source: ELA Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 520
• Est. completion date: April 2013
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• Paradym CRT + Physiological Diagnosis (PhD)
All subjects will undergo CRT therapy with the Physiological Diagnosis (PhD) feature enabled.

Locations

Country	Name	City	State
United States	Mountain Vista Hospital	Mesa	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
ELA Medical, Inc.	LivaNova

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		Thirteen months	No
Primary	Mean number of false positives per patient per year.		Thirteen Months	No