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
  Purpose

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.


Condition Intervention Phase
Dilated Cardiomyopathy
Device: Renewal
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ACC - Atrial Contribution to CRT

Resource links provided by NLM:


Further study details as provided by Guidant Corporation:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 43
Study Start Date: November 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Device: Renewal
Renewal is a CRT-D device for cardiac resynchronization therapy

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).

  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

Locations
Denmark
Rigshospitalet
Copenhagen, Denmark
Sponsors and Collaborators
Guidant Corporation
Investigators
Principal Investigator: Jasper Hastrup Svendson, MD Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Guidant Corporation
ClinicalTrials.gov Identifier: NCT00180323     History of Changes
Other Study ID Numbers: ACC Version 1.1 11/09/2003
Study First Received: September 12, 2005
Results First Received: March 9, 2012
Last Updated: October 11, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Cardiomyopathy, Dilated
Cardiomyopathies
Cardiomegaly
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014