Brief Title
ACC - Atrial Contribution to CRT
Official Title
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 Phase
Phase 4
Study Type
Interventional
Primary Outcome
Aortic Velocity Time Integral (VTI)
Secondary Outcome
6 Minute Walk Test
Condition
Dilated Cardiomyopathy
Intervention
Renewal
Study Arms / Comparison Groups
Renewal CRT (CRT ICD)
Description: 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).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
43
Start Date
November 2004
Completion Date
December 2008
Primary Completion Date
December 2008
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jasper Hastrup Svendson, MD, ,
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT00180323
Organization ID
ACC Version 1.1 11/09/2003
Responsible Party
Sponsor
Study Sponsor
Boston Scientific Corporation
Study Sponsor
Jasper Hastrup Svendson, MD, Principal Investigator, Rigshospitalet, Denmark
Verification Date
October 2012