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OpenTrials
Completed

NCT Number: NCT00180323

ACC - Atrial Contribution to CRT

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Renewal

Device

Renewal is a CRT-D device for cardiac resynchronization therapy

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Sep 16, 2005
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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