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Heart FailurePhase 4PING-EPNCT01109641

PhrenIc Nerve mappinG and Stimulation EP Catheter Study: PING-EP Study

A Phase 4 study testing diagnostic electrophysiology catheter in people with Heart Failure, run by Medtronic Italia at 4 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
diagnostic electrophysiology catheter
Type of treatment
Medical device
How many people
40 participants
Where
4 sitesItaly
Study dates
Feb 2010to Oct 2010
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

Italy4 sites

  • Azienda Ospedaliero-Universitana di Bologna, Policlinico S. Orsola Malpighi

    Bologna, Bologna, 40138

  • Azienda Ospedaliero-universitaria Careggi

    Florence, Firenze, 50141

  • Azienda Unità Socio Sanitaria di Dolo Mirano

    Mirano, Venezia, 30035

  • Ospedale S. Maria della Misericordia

    Rovigo, Rovigo, 45100

Other trials in Italy

About this study

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.

Conditions
Heart Failure
Being tested
diagnostic electrophysiology catheter
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • diagnostic electrophysiology catheterDevice

    electrical measurements through a diagnostic electrophysiology catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effect of electrode property on phrenic nerve stimulation (PNS)

    Effect of electrode property on PNS in the cardiac veins

    Measured: at implant

Secondary outcomes (4)

  1. Effect of electrode configuration on phrenic nerve stimulation (PNS)

    Measured: at implant

  2. Electrode polarity effect on phrenic nerve stimulation (PNS)

    Measured: at implant

  3. Effect of electrode property on sensing (r-wave amplitude)

    Measured: at implant

  4. Incidence of phrenic nerve stimulation (PNS) in the cardiac veins

    Incidence of PNS occurrence in different locations in the cardiac vein

    Measured: at implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2010 (estimated)
  2. Study startFeb 2010
  3. Primary completionOct 2010
  4. Study completionOct 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01109641
Sponsor's protocol ID
MDT-PINGEP
Acronym
PING-EP
Status last verified
Oct 2010
First submitted
21 Apr 2010
Last updated
7 Oct 2010
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17565085

  • 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.

    PubMed 16403156

  • 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.

    PubMed 15955178

  • 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.

    PubMed 11559679

  • 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.

    PubMed 15234410

  • 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.

    PubMed 15683519

  • 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.

    PubMed 17599455

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing diagnostic electrophysiology catheter in people with Heart Failure, run by Medtronic Italia at 4 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of electrode property on phrenic nerve stimulation (PNS) (time frame: at implant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01109641, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2010.

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PING-EP Clinical Trial NCT01109641 | AzTrials