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

Phase 2

Completed

• Conditions: Congestive Heart Failure
• Interventions: Device: Paradym CRT + Physiological Diagnosis (PhD)

• Registration Number: NCT00957541
• Lead Sponsor: ELA Medical, Inc.

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.

Study Timeline

• Study First Submitted: 2009-08-10
• Study First Submitted QC: 2009-08-11
• Study First Posted: 2009-08-12
• Study Start: 2009-09
• Primary Completion: 2011-04
• Study Completion: 2013-04
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-14
• Last Update Posted: 2014-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 520

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CRT Therapy	Paradym CRT + Physiological Diagnosis (PhD)	All patients will receive CRT therapy with the Physiological Diagnosis (PhD) feature enabled.

Primary Outcome Measures

Name	Time	Method
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
Mean number of false positives per patient per year.	Thirteen Months

Trial Locations

Locations (1)

Mountain Vista Hospital; 🇺🇸 Mesa, Arizona, United States