NCT01297283

Brief Summary

The leadless electrocardiogram (LECG) is a new technology incorporated into the Consulta CRT-P to obtain an ECG signal from the Consulta CRT-P similar to a surface ECG obtained from the device programmer (PECG) or an external ECG machine. The purpose of the study is to obtain more data on leadless ECG to determine whether LECG during standard CRT follow-up can indeed adequately replace surface ECG and to evaluate if it can be used during remote follow-up evaluations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
195

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

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

July 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 16, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

April 1, 2014

Completed
Last Updated

July 18, 2025

Status Verified

February 1, 2017

Enrollment Period

1.4 years

First QC Date

February 3, 2011

Results QC Date

December 23, 2013

Last Update Submit

June 30, 2025

Conditions

Heart Failure

Keywords

Heart failureCardiac resynchronizationLeadless ECGFollow-up

Outcome Measures

Primary Outcomes (1)

  • Proportion of Patients With LECG Performing Clinically Equivalent to PECG During Standard Pacemaker Follow-up Procedure.

    During CRT-P standard follow-up, ECG is used to determine atrial, left and right ventricular pacing thresholds. As primary endpoint, we will consider the proportion of patients for which for all leads LECG provides pacing threshold values that are clinically equivalent to those obtained with PECG taken as reference. The analysis will be performed on data collected at the 1-Month Follow-Up visit when the device pocket healing process is completed. Clinical equivalence will be defined as the LECG threshold values being no more than 0.5 volts different from the PECG threshold values.

    30 to 120 days

Secondary Outcomes (5)

  • Evaluation of the Possibility to Determine Ventricle Capture by an Independent Reviewer.

    30 to 120 days

  • Evaluation of the Stability of LECG Performance Over Time.

    30 to 120 days

  • Quality of LECG in New Devices Versus Device Replacements.

    30 to 120 days

  • Effect of Posture Changes and Artifact-inducing Maneuvers on the LECG Quality.

    30 to 120 days

  • Evaluation of Factors Such as Device Rotation, Device Fixation, Device Side Facing the Skin, Position of Lead Loops in the Pocket, Use of Antiseptic Solution, Skin Type, Body Mass Index on the Quality of Leadless ECG.

    30 to 120 days

Study Arms (2)

Leadless ECG first

EXPERIMENTAL

Measurement of pacing thresholds are done first with the support of a leadless ECG provided by the implanted device

Other: LECG first

Programmer ECG first

ACTIVE COMPARATOR

Measurements of pacing thresholds are done first with the support of the programmer ECG

Other: Programmer ECG first

Interventions

LECG firstOTHER

Measurement of the pacing threshold with the support of a leadless ECG

Leadless ECG first
Programmer ECG firstOTHER

Pacing threshold measurements are done with the support of the programmer ECG

Programmer ECG first

Eligibility Criteria

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

You may qualify if:

  • patient with a CRT-P indication and
  • patient who has signed an informed consent form.

You may not qualify if:

  • patient younger than 18 years and/or
  • unable to complete the 1-Month Follow-up visit and/or
  • legally incompetent or illiterate and therefore unable to provide an informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital La Pitié Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Latifa Foudali
Organization
Medtronic
latifa.foudali@medtronic.com
+33 631992144

Study Officials

  • Françoise HIDDEN-LUCET, MD

    Hôpital La Pitié Salpêtrière, Paris, France

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2011

First Posted

February 16, 2011

Study Start

July 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

July 18, 2025

Results First Posted

April 1, 2014

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

No sharing

Locations

FR(1)