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N/A Completed N=43 Treatment

ACC - Atrial Contribution to CRT

Dilated Cardiomyopathy
Source: ClinicalTrials.gov NCT00180323 ↗
Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcomePrimary: Aortic Velocity Time Integral (VTI) — 22.4; 21.7; 19.4; 18.1 cm

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Aortic Velocity Time Integral (VTI)		 22.4; 21.7; 19.4; 18.1; 23.6; 21.9 —
PRIMARY
Optimal AV-Delay (AVD)		 115; 119; 123; 127; 117; 117 —
SECONDARY
6 Minute Walk Test		 388; 470; 497 —
SECONDARY
Left Ventricular Ejection Fraction (LVEF)		 21; 24; 24 —

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00180323). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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