NCT00957541

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2009

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

May 15, 2014

Status Verified

May 1, 2014

Enrollment Period

1.6 years

First QC Date

August 10, 2009

Last Update Submit

May 14, 2014

Conditions

Congestive Heart Failure

Keywords

NYHA Class III or IVImplantable Cardiac DefibrillatorCardiac Resynchronization Therapy

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

CRT Therapy

EXPERIMENTAL

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

Device: Paradym CRT + Physiological Diagnosis (PhD)

Interventions

Paradym CRT + Physiological Diagnosis (PhD)DEVICE

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

CRT Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mountain Vista Hospital

Mesa, Arizona, 85209, United States

Location

Related 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.

    PMID: 20947571BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2009

First Posted

August 12, 2009

Study Start

September 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2013

Last Updated

May 15, 2014

Record last verified: 2014-05

Locations

US(1)