PhrenIc Nerve mappinG and Stimulation EP Catheter Study: PING-EP Study
NCT ID: NCT01109641
Last Updated: 2010-10-07
Study Results
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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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2010-02-28
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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diagnostic electrophysiology catheter
electrical measurements through a diagnostic electrophysiology catheter
Eligibility Criteria
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Inclusion Criteria
* Patient has signed and dated the study-specific Patient Informed Consent form
* Subject is at least 18 years of age
Exclusion Criteria
* Pregnant woman
* Patient is enrolled or planning to participate in any concurrent study, which would confound the results of this trial as determined by Medtronic, during the course of this clinical study
18 Years
ALL
No
Sponsors
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Medtronic Italia
INDUSTRY
Responsible Party
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Medtronic Italia
Principal Investigators
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Mauro Biffi
Role: PRINCIPAL_INVESTIGATOR
Policlinico S. Orsola Malpighi, Bologna, Italy
Francesco Zanon
Role: PRINCIPAL_INVESTIGATOR
Ospedale S. Maria della Misericordia, Rovigo, Italy
Luigi Padeletti
Role: PRINCIPAL_INVESTIGATOR
Azienda ospedaliero-universitaria Careggi, Firenze, Italy
Manuel Bertaglia
Role: PRINCIPAL_INVESTIGATOR
Azienda Unità Socio Sanitaria di Dolo Mirano, Mirano (VE), Italy
Locations
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Azienda Ospedaliero-Universitana di Bologna, Policlinico S. Orsola Malpighi
Bologna, Bologna, Italy
Azienda Ospedaliero-universitaria Careggi
Florence, Firenze, Italy
Ospedale S. Maria della Misericordia
Rovigo, Rovigo, Italy
Azienda Unità Socio Sanitaria di Dolo Mirano
Mirano, Venezia, Italy
Countries
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References
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McAlister FA, Ezekowitz J, Hooton N, Vandermeer B, Spooner C, Dryden DM, Page RL, Hlatky MA, Rowe BH. Cardiac resynchronization therapy for patients with left ventricular systolic dysfunction: a systematic review. JAMA. 2007 Jun 13;297(22):2502-14. doi: 10.1001/jama.297.22.2502.
Gurevitz O, Nof E, Carasso S, Luria D, Bar-Lev D, Tanami N, Eldar M, Glikson M. Programmable multiple pacing configurations help to overcome high left ventricular pacing thresholds and avoid phrenic nerve stimulation. Pacing Clin Electrophysiol. 2005 Dec;28(12):1255-9. doi: 10.1111/j.1540-8159.2005.00265.x.
Albertsen AE, Nielsen JC, Pedersen AK, Hansen PS, Jensen HK, Mortensen PT. Left ventricular lead performance in cardiac resynchronization therapy: impact of lead localization and complications. Pacing Clin Electrophysiol. 2005 Jun;28(6):483-8. doi: 10.1111/j.1540-8159.2005.40066.x.
Alonso C, Leclercq C, d'Allonnes FR, Pavin D, Victor F, Mabo P, Daubert JC. Six year experience of transvenous left ventricular lead implantation for permanent biventricular pacing in patients with advanced heart failure: technical aspects. Heart. 2001 Oct;86(4):405-10. doi: 10.1136/heart.86.4.405.
Knight BP, Desai A, Coman J, Faddis M, Yong P. Long-term retention of cardiac resynchronization therapy. J Am Coll Cardiol. 2004 Jul 7;44(1):72-7. doi: 10.1016/j.jacc.2004.03.054.
Ellery S, Paul V, Prenner G, Tscheliessnigg K, Merkely B, Malinowski K, Frohlig G, Hintringer F, Bosse O, Diotallevi P, Ravazzi AP, Flathmann H, Danilovic D, Unterberg-Buchwald C; OVID Study Investigators. A new endocardial "over-the-wire" or stylet-driven left ventricular lead: first clinical experience. Pacing Clin Electrophysiol. 2005 Jan;28 Suppl 1:S31-5. doi: 10.1111/j.1540-8159.2005.00084.x.
Matsumoto Y, Krishnan S, Fowler SJ, Saremi F, Kondo T, Ahsan C, Narula J, Gurudevan S. Detection of phrenic nerves and their relation to cardiac anatomy using 64-slice multidetector computed tomography. Am J Cardiol. 2007 Jul 1;100(1):133-7. doi: 10.1016/j.amjcard.2007.01.072. Epub 2007 May 21.
Other Identifiers
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MDT-PINGEP
Identifier Type: -
Identifier Source: org_study_id