Back to resultsPhrenIc Nerve mappinG and Stimulation EP Catheter Study: PING-EP Study (PING-EP)
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
diagnostic electrophysiology catheter
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Subject is indicated for a cardiac resynchronization therapy-pacemaker or defibrillator (CRT-P/CRT-D) implant, for an upgrading from a previously implanted single/dual chamber pacemaker/implantable cardioverter (ICD) or for system revision requiring repositioning of the transvenous left ventricular (LV) lead
- Patient has signed and dated the study-specific Patient Informed Consent form
- Subject is at least 18 years of age
Exclusion Criteria:
- Patient has a previous LV lead implanted not requiring repositioning
- 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
Sites / Locations
- Azienda Unità Socio Sanitaria di Dolo Mirano
- Azienda Ospedaliero-Universitana di Bologna, Policlinico S. Orsola Malpighi
- Azienda Ospedaliero-universitaria Careggi
- Ospedale S. Maria della Misericordia
Outcomes
Primary Outcome Measures
Effect of electrode property on phrenic nerve stimulation (PNS)
Effect of electrode property on PNS in the cardiac veins
Secondary Outcome Measures
Effect of electrode configuration on phrenic nerve stimulation (PNS)
Electrode polarity effect on phrenic nerve stimulation (PNS)
Effect of electrode property on sensing (r-wave amplitude)
Incidence of phrenic nerve stimulation (PNS) in the cardiac veins
Incidence of PNS occurrence in different locations in the cardiac vein
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01109641
Brief Title
PhrenIc Nerve mappinG and Stimulation EP Catheter Study: PING-EP Study
Acronym
PING-EP
Official Title
PhrenIc Nerve mappinG and Stimulation EP Catheter Study: PING-EP Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medtronic Italia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The PING-EP study is designed to evaluate electrode properties on phrenic nerve stimulation (PNS) in coronary sinus using a commercially available diagnostic electrophysiology catheter.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
diagnostic electrophysiology catheter
Intervention Description
electrical measurements through a diagnostic electrophysiology catheter
Primary Outcome Measure Information:
Title
Effect of electrode property on phrenic nerve stimulation (PNS)
Description
Effect of electrode property on PNS in the cardiac veins
Time Frame
at implant
Secondary Outcome Measure Information:
Title
Effect of electrode configuration on phrenic nerve stimulation (PNS)
Time Frame
at implant
Title
Electrode polarity effect on phrenic nerve stimulation (PNS)
Time Frame
at implant
Title
Effect of electrode property on sensing (r-wave amplitude)
Time Frame
at implant
Title
Incidence of phrenic nerve stimulation (PNS) in the cardiac veins
Description
Incidence of PNS occurrence in different locations in the cardiac vein
Time Frame
at implant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is indicated for a cardiac resynchronization therapy-pacemaker or defibrillator (CRT-P/CRT-D) implant, for an upgrading from a previously implanted single/dual chamber pacemaker/implantable cardioverter (ICD) or for system revision requiring repositioning of the transvenous left ventricular (LV) lead
Patient has signed and dated the study-specific Patient Informed Consent form
Subject is at least 18 years of age
Exclusion Criteria:
Patient has a previous LV lead implanted not requiring repositioning
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauro Biffi
Organizational Affiliation
Policlinico S. Orsola Malpighi, Bologna, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francesco Zanon
Organizational Affiliation
Ospedale S. Maria della Misericordia, Rovigo, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luigi Padeletti
Organizational Affiliation
Azienda ospedaliero-universitaria Careggi, Firenze, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manuel Bertaglia
Organizational Affiliation
Azienda Unità Socio Sanitaria di Dolo Mirano, Mirano (VE), Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Unità Socio Sanitaria di Dolo Mirano
City
Mirano
State/Province
Venezia
ZIP/Postal Code
30035
Country
Italy
Facility Name
Azienda Ospedaliero-Universitana di Bologna, Policlinico S. Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliero-universitaria Careggi
City
Firenze
ZIP/Postal Code
50141
Country
Italy
Facility Name
Ospedale S. Maria della Misericordia
City
Rovigo
ZIP/Postal Code
45100
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
17565085
Citation
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.
Results Reference
background
PubMed Identifier
16403156
Citation
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.
Results Reference
background
PubMed Identifier
15955178
Citation
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.
Results Reference
background
PubMed Identifier
11559679
Citation
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.
Results Reference
background
PubMed Identifier
15234410
Citation
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.
Results Reference
background
PubMed Identifier
15683519
Citation
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.
Results Reference
background
PubMed Identifier
17599455
Citation
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.
Results Reference
background
Learn more about this trial
PhrenIc Nerve mappinG and Stimulation EP Catheter Study: PING-EP Study
We'll reach out to this number within 24 hrs