NCT02326519

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 29, 2014

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2015

Completed
Last Updated

December 20, 2017

Status Verified

December 1, 2017

Enrollment Period

1.3 years

First QC Date

December 10, 2014

Last Update Submit

December 18, 2017

Conditions

Cardiac Arrhythmias

Outcome Measures

Primary Outcomes (1)

  • The electrical signal mean amplitude (mv) during AV synchronous pacing.

    2 minutes during the procedure

Study Arms (1)

Intracardiac electrode catheter

OTHER

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

Other: Intracardiac electrode catheter

Interventions

Intracardiac electrode catheterOTHER

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

Intracardiac electrode catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Any condition which precludes the subject's ability to comply with the study requirements
  • Subject has physical conditions that contraindicate the use of the device per approved labeling, including but not limited to active sepsis, known sensitivity to heparin, cannot undergo standard anticoagulation protocol for cardiac procedure, blood clotting abnormalities or a recent coagulopathy or embolic event, venous filtering device (Greenfield Filter) and obstructed or damaged vessel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Allgemeines Krankenhaus der Stadt Linz

Linz, Austria

Location

Hôpital Cardiologique du Haut-Lévêque

Bordeaux, France

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2014

First Posted

December 29, 2014

Study Start

October 1, 2013

Primary Completion

January 13, 2015

Study Completion

March 13, 2015

Last Updated

December 20, 2017

Record last verified: 2017-12

Locations

FR(1)AU(1)