Ventricular Wall Motion Characterization

NCT ID: NCT01629160

Last Updated: 2019-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation Tachycardia, Ventricular

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gerhard Hindricks, MD

Role: PRINCIPAL_INVESTIGATOR

Herzzentrum Leipzig GmbH

Locations

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Herzzentrum Leipzig GmbH

Leipzig, , Germany

Site Status

Countries

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Germany

References

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Piorkowski C, Arya A, Markovitz CD, Razavi H, Jiang C, Rosenberg S, Breithardt OA, Rolf S, John S, Kosiuk J, Huo Y, Doring M, Richter S, Ryu K, Gaspar T, Prinzen FW, Hindricks G, Sommer P. Characterizing left ventricular mechanical and electrical activation in patients with normal and impaired systolic function using a non-fluoroscopic cardiovascular navigation system. J Interv Card Electrophysiol. 2018 Apr;51(3):205-214. doi: 10.1007/s10840-018-0317-3. Epub 2018 Jan 31.

Reference Type DERIVED
PMID: 29388068 (View on PubMed)

Other Identifiers

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642

Identifier Type: -

Identifier Source: org_study_id

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