The HF-HRV Registry | NCT00236236

Studies
The HF-HRV Registry

NCT00236236

Sponsor

Boston Scientific Corporation

Status

Completed

Last Update Posted

Nov 14, 2006Estimated

Enrollment

1,400

Phase

Not provided

Conditions

Heart Failure
Arrhythmia

Interventions

Cardiac Resynchronization Therapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2003

Primary Completion Date

Not provided

Completion Date

May 2005

First Submitted Date

Sep 2, 2005

First Submission Date that Met QC Criteria

Oct 10, 2005

First Posted Date

Oct 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2006

Last Update Posted Date

Nov 14, 2006Estimated

Description Module

Brief Summary

The Registry will evaluate how HRV Monitor diagnostics change after cardiac resynchronization therapy in patients with heart failure.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,400

Name	Type	Description	Arm Group Labels	Other Names
Cardiac Resynchronization Therapy	Device

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients receiving their first CRT-D
Patients who sign and date a Patient Informed Consent prior to device implant
Patients who are available and willing to attend follow-up visits at the study center in which they were enrolled

Exclusion Criteria:

Patients who are anticipated to receive pacing modes other than DDD or VDD (i.e., chronic atrial fibrillation patients are excluded), or patients who are anticipated to receive adaptive rate therapy
Patients who are younger than 18 years of age
Patients whose life expectancy is less than six-months due to other medical conditions
Patients with or who are likely to receive a tricuspid or other valve prosthesis
Patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the current study
Women who are pregnant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Kellie Chase	Guidant Corporation	Study Chair

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D001145	Arrhythmias, Cardiac

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D058406	Cardiac Resynchronization Therapy

Ancestor Terms

ID	Term
D002304	Cardiac Pacing, Artificial
D004599	Electric Stimulation Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided