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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

520 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2013-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Left Ventricular Autothreshold, Phase Two

NCT01242722

Heart Failure

COMPLETED

Safety and Efficacy of Automatic Testing Feature in New ICDs and CRT-Ds

NCT00746356

Heart Failure Ventricular Arrythmias

COMPLETED NA

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

NCT02167789

Heart Failure

COMPLETED PHASE3

PARTNERS HF: Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure

NCT00279955

Heart Failure, Congestive

COMPLETED

Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure

NCT01486316

Atrial Fibrillation Heart Failure

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Congestive Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CRT Therapy

All patients will receive CRT therapy with the Physiological Diagnosis (PhD) feature enabled.

Group Type EXPERIMENTAL

Paradym CRT + Physiological Diagnosis (PhD)

Intervention Type DEVICE

All subjects will undergo CRT therapy with the Physiological Diagnosis (PhD) feature enabled.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Paradym CRT + Physiological Diagnosis (PhD)

All subjects will undergo CRT therapy with the Physiological Diagnosis (PhD) feature enabled.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No