ACC - Atrial Contribution to CRT

This study is currently recruiting participants.

Verified by Guidant Corporation, December 2007

Sponsored by:	Guidant Corporation
Information provided by:	Guidant Corporation
ClinicalTrials.gov Identifier:	NCT00180323

Purpose

This prospective, randomized study will evaluate in patients, fulfilling implant criteria for Cardiac Resynchronisation Therapy (CRT) implant, the optimal atrial contribution to the resynchronised ventricles in the event of right atrial pacing.

Condition	Intervention	Phase
Dilated Cardiomyopathy	Device: Renewal	Phase IV

MedlinePlus related topics: Cardiomyopathy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment
Official Title:	ACC - Atrial Contribution to CRT

Further study details as provided by Guidant Corporation:

Primary Outcome Measures:

Cardiac Output [ Time Frame: At implant ] [ Designated as safety issue: No ]

Estimated Enrollment:	44
Study Start Date:	November 2004
Estimated Study Completion Date:	December 2008

Intervention Details:

Renewal is a CRT-D device for cardiac resynchronization therapy

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Symptoms of heart failure
Left ventricular dysfunction
Ventricular dyssynchrony
18 years or of legal age in order to give informed consent according to national laws
Able to understand the nature of the procedure
Available for follow-up on a regular basis at an approved investigational center

Exclusion Criteria:

Atrial Fibrillation
Life expectancy of less than six months due to other medical conditions
For women: pregnancy or absence of medically accepted birth control
Inability or refusal to sign the Patient Informed Consent
Inability or refusal to comply with the follow up schedule or protocol requirements
Inability to undergo device implant, including general anaesthesia if required
Mechanical tricuspid prosthesis
Currently enrolled in another investigational study, including drug investigations
Hypertrophic Obstructive Cardiomyopathy (HOCM)
Not meeting the inclusion criteria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180323

Contacts

Contact: Jesper Hastrup Svendsen, MD

+ 45 35453545

Locations

Denmark
Rigshospitalet	Recruiting
Copenhagen, Denmark
Contact: Jasper Hastrup Svendson, MD
Principal Investigator: Jasper Hastrup Svendson, MD

Sponsors and Collaborators

Guidant Corporation

Investigators

Principal Investigator:

Jasper Hastrup Svendson, MD

Rigshospitalet, Copenhagen, Denmark

More Information

Responsible Party:	Guidant Sweden ( Hakan Hornell )
Study ID Numbers:	ACC Version 1.1 11/09/2003
Study First Received:	September 12, 2005
Last Updated:	December 17, 2007
ClinicalTrials.gov Identifier:	NCT00180323
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Study placed in the following topic categories:

Heart Diseases
Cardiomyopathy, Dilated
Dilated cardiomyopathy
Cardiomegaly
Cardiomyopathies

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009