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OpenTrials
Completed

NCT Number: NCT01629160

Ventricular Wall Motion Characterization

The purpose of this study is to evaluate feasibility of using new technologies to characterize ventricular wall motion in patients indicated for mapping and ablation procedures. Echo will be performed preoperatively and patients will receive a 1-month followup telephone call.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Herzzentrum Leipzig GmbH

Leipzig, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Be in sinus rhythm
  • Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigational Plan described evaluations
  • Be undergoing mapping and ablation that requires left heart access for either ventricular tachycardia (VT) or atrial fibrillation (AF) according to HRS (Heart Rhythm Society)/ESC (European Society of Cardiology)/German National guidelines. The patient needs to have at least one of the following indications for left heart mapping and ablation to be included in the study: a) Symptomatic sustained monomorphic VT (SMVT), or b) Frequent PVCs, non-sustained VT, or VT that is presumed to cause ventricular dysfunction, or c) Bundle branch reentrant or interfascicular VTs, or d) Symptomatic AF with indication for ablation per current HRS/ESC/German National guidelines in a patient who is either 1) refractory or intolerant to at least one Class 1 or Class 3 antiarrhythmic medication, or 2) unable/unwilling to take antiarrhythmic drug therapy and chooses ablation as the first line of therapy

Exclusion criteria

  • Have permanent AF
  • Exhibit Cheyne-Stokes respiration
  • Have a recent myocardial infarction within 40 days prior to enrollment
  • Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures
  • Have had a recent CVA or TIA within 3 months prior to enrollment
  • Be less than 18 years of age
  • Be pregnant
  • Be currently participating in any other clinical investigation

Treatment and study plan

Primary outcomes

  1. Feasibility of Ventricular Wall Motion Characterization

    Time frame: Mapping and Ablation Procedure

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Characterization of Normal and Abnormal Ventricular Wall Motion

Important dates

Study start
2012
Primary completion
2014
First posted
Jun 27, 2012
Registry last updated
Feb 4, 2019

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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