ACC - Atrial Contribution to CRT

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Guidant Corporation

ClinicalTrials.gov Identifier:

NCT00180323

First received: September 12, 2005

Last updated: October 11, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

October 11, 2012

Start Date ^ICMJE

November 2004

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Aortic Velocity Time Integral (VTI) [ Time Frame: At implant (baseline), 3 months and 6 months Follow-up ] [ Designated as safety issue: No ]
Velocity time integral of the aortic flow correlates with cardiac output and is an accepted parameter for optimization of Cardiac Resynchronization Therapy (CRT).
Optimal AV-Delay (AVD) [ Time Frame: Implant (baseline), 3 months and 6 months Follow-up ] [ Designated as safety issue: No ]
Optimal AV-Delay will be measured at implant (baseline ), 3months and 6 months Follow-up for intrinsic heart rate, and 10, 20 and 30 Bpm above intrinsic heart rate.

Original Primary Outcome Measures ^ICMJE

Cardiac Output

Change History

Complete list of historical versions of study NCT00180323 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

6 Minute Walk Test [ Time Frame: implant (baseline), 3 months and 6 months Follow-up ] [ Designated as safety issue: No ]
6 Minute Walk Test was performed at implant (baseline), 3 months and 6 months follow-up Distance walked within 6 minutes is assessed in meter. This is a test that reflects daily life activities of elderly patients.
Left Ventricular Ejection Fraction (LVEF) [ Time Frame: implant (baseline), 3 Months, 6 Months ] [ Designated as safety issue: No ]
Left ventricular Ejection Fraction (LVEF) was measured before implant (baseline) and at 3 and 6 months Follow-up

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

ACC - Atrial Contribution to CRT

Official Title ^ICMJE

ACC - Atrial Contribution to CRT

Brief Summary

This prospective 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.

Detailed Description

All patients will undergo advanced echocardiographic examination pre-operative, pre-discharge after implantation and at 3 and 6-months follow-up. AV-delay optimization will be performed using aortic VTI measured by continuous wave Doppler in a modified 4-chamber view. During optimisation aortic VTI will be measured at different heart rates reached by increasing atrial pacing 10, 20 and 30 beats above intrinsic heart rate (IHR).

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Dilated Cardiomyopathy

Intervention ^ICMJE

Device: Renewal

Renewal is a CRT-D device for cardiac resynchronization therapy

Study Arm (s)

Experimental: Renewal CRT (CRT ICD)

Single arm study only. All patients will undergo advanced echocardiographic examination pre-operative, pre-discharge after implantation and at 3 and 6-months follow-up. AV-delay optimization will be performed using aortic VTI (Velocity Time Integral) measured by continuous wave Doppler in a modified 4-chamber view. During optimisation aortic VTI will be measured at different heart rates reached by increasing atrial pacing 10, 20 and 30 beats above intrinsic heart rate (IHR).

Intervention: Device: Renewal

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00180323

Other Study ID Numbers ^ICMJE

ACC Version 1.1 11/09/2003

Has Data Monitoring Committee

Responsible Party

Guidant Corporation

Study Sponsor ^ICMJE

Guidant Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jasper Hastrup Svendson, MD

Rigshospitalet, Denmark

Information Provided By

Guidant Corporation

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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