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Electrical Signal Collection From a 20 Pole Catheter During Routine Cardiac Procedures

Electrical Signal Collection From a 20 Pole Catheter During Routine Cardiac Procedures

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02326519
Acronym
E20PC
Enrollment
31
Registered
2014-12-29
Start date
2013-10-01
Completion date
2015-03-13
Last updated
2017-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrhythmias

Brief summary

Routine data collection will be conducted during normal sinus rhythm and AV synchronous pacing for approximately 20 minutes. The data collected will then be processed and the P, R and T wave amplitudes will be measured.

Detailed description

The purpose of this study is to collect atrio-ventricular electrograms using a sequence of tip-ring spacings in patients undergoing routine cardiac procedures (EP study, pacemaker/ICD/CRT implant). To collect these signals, a 20 pole catheter (Medtronic StableMapr intracardiac steerable electrode catheter) will be acutely placed in the RV apex during a routine cardiac procedure. Routine data collection will be conducted during normal sinus rhythm and AV synchronous pacing for approximately 20 minutes. The data collected will then be processed and the P, R and T wave amplitudes will be measured.

Interventions

OTHERIntracardiac electrode catheter

All patient in the study will have the same data collected using the Steerable intracardiac electrode catheter

Sponsors

Medtronic Cardiac Rhythm and Heart Failure
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Subjects aged 18 or above, or of legal age to give consent specific to the national law of the countries in which the study is being conducted * Subjects who are undergoing a cardiac procedure where routine placement of cardiac catheter can be performed * Subjects are willing to provide Informed Consent

Exclusion criteria

* • Subject has

Design outcomes

Primary

MeasureTime frame
The electrical signal mean amplitude (mv) during AV synchronous pacing.2 minutes during the procedure

Countries

Austria, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026