Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

ACC - Atrial Contribution to CRT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00180323
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : November 12, 2012
Last Update Posted : February 3, 2016
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 16, 2005
Results First Submitted Date  ICMJE March 9, 2012
Results First Posted Date  ICMJE November 12, 2012
Last Update Posted Date February 3, 2016
Study Start Date  ICMJE November 2004
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2012)
  • Aortic Velocity Time Integral (VTI) [ Time Frame: At implant (baseline), 3 months and 6 months Follow-up ]
    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 ]
    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
 (submitted: September 12, 2005)
Cardiac Output
Change History Complete list of historical versions of study NCT00180323 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2012)
  • 6 Minute Walk Test [ Time Frame: implant (baseline), 3 months and 6 months Follow-up ]
    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 ]
    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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Dilated Cardiomyopathy
Intervention  ICMJE Device: Renewal
Renewal is a CRT-D device for cardiac resynchronization therapy
Study Arms  ICMJE 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
Actual Enrollment  ICMJE
 (submitted: October 11, 2012)
43
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
44
Actual Study Completion Date  ICMJE December 2008
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00180323
Other Study ID Numbers  ICMJE ACC Version 1.1 11/09/2003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jasper Hastrup Svendson, MD Rigshospitalet, Denmark
PRS Account Boston Scientific Corporation
Verification Date October 2012

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