ACC – Atrial Contribution to CRT

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 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

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