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Non-invasive Mapping of Rhythm Disorders (CARRY)

Primary Purpose

Cardiac Rhythm Disorders

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cardioinsight® mapping system
Conventional method without non-invasive mapping
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiac Rhythm Disorders

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Oral agreement of the patient or of the holder of parental responsibility after reading the informed consent form.
  • Patients with the following 3 conditions :
  • Ablation of drugs rebels arrhythmias.
  • Or implantation or programming of a pacemaker (pacemaker or defibrillator)
  • Or symptoms and / or cardiopathy with risk of sudden death.

Exclusion Criteria:

  • Pregnancy and lactation.
  • Patients unable to give oral agreement.
  • Inconsistent patient's morphology with the establishment of the electrode jacket

Sites / Locations

  • CHU de Bordeaux

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group 1 : Cardiac rythm radiofrequency ablation

Group 1: Implantation or programming of a pacemaker

Group 1: Risk of serious arrhythmias or sudden death

Group 2: Cardiac rythm radiofrequency ablation

Group 2 : Implantation or programming of a pacemaker

Group 2 : Risk of serious arrhythmias or sudden death

Arm Description

Prospective recruitment

Prospective recruitment

Prospective recruitment

Retrospective recruitment

Retrospective recruitment

Retrospective recruitment

Outcomes

Primary Outcome Measures

Arrhythmia termination during ablation guided by the Cardioinsight® mapping system
Variation of dP/dT measurement between baseline and after implantation or programmation of a pacemaker guided by the Cardioinsight® mapping system
In mmHg/s
Measurement of the activation-recovery interval defined as the interval between a local depolarization time and repolarization time for patients referred for evaluation of the risk of occurrence of a serious rhythm disorder or sudden death
In ms

Secondary Outcome Measures

Arrhythmia recurrence at 1 year after ablation guided by the Cardioinsight® mapping system
For patients referred for implantation or programming of a pacemaker: Comparison of 6 Minutes Walk Test performed before and 6 months after implantation and/or programmation guided by the Cardioinsight® mapping system
In meters
For patients referred for implantation or programming of a pacemaker: Comparison of left ventricular ejection fraction performed before and 6 months after implantation and/or programmation guided by the Cardioinsight® mapping system
In percentage
Occurence of syncope, aborted sudden death or sudden death during follow-up for patients referred for evaluation of the risk of occurrence of a serious rhythm disorder or sudden death

Full Information

First Posted
November 5, 2015
Last Updated
February 8, 2022
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT02647749
Brief Title
Non-invasive Mapping of Rhythm Disorders
Acronym
CARRY
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 19, 2015 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This current care protocol follows the biomedical research protocol entitled "Non-invasive mapping of the heart ECG high amplification" that demonstrated the clinical value of noninvasive Cardioinsight® mapping system. Guide the management of patients hospitalized for cardiac rhythm radiofrequency ablation of cardiac arrhythmias, implantation or programming of a pacemaker, or assess the risk of serious arrhythmias or sudden death, with the currently used non-invasive mapping routine. The results obtained with non-invasive mapping will be compared with those obtained with the conventional method without non-invasive mapping.
Detailed Description
This current care protocol is for 3 groups of patients : Role of mapping arrhythmias before radiofrequency ablation : Radiofrequency ablation is a treatment of atrial or ventricular arrhythmias resistant to drug treatment. The electrocardiogram does not allow a full diagnosis of arrhythmias and it appears difficult to get a comprehensive and simultaneous view of cardiac activity during invasive maps. The Investigators have demonstrated the feasibility of mapping atrial fibrillation and its usefulness to guide radiofrequency ablation. The non-invasive mapping would allow a better understanding of complex cardiac arrhythmias mechanism (atrial fibrillation, ventricular tachycardia and ventricular fibrillation in particular), would identify the arrhythmogenic sites and thus facilitate radiofrequency ablation. Optimizing the site of implantation of cardiac pacing leads and programming the pacemaker: The optimal position of the cardiac pacing leads may vary from one patient to another and the current choice of implantation sites is essentially guided by imaging and does not use power requirements because of the inadequacies of the ECG standard. The Investigators have already demonstrated the usefulness of non-invasive mapping in the selection of potential responders to cardiac resynchronization therapy. The non-invasive mapping would study the cardiac electrical activation in order to determine the optimal pacing sites and optimum programming according to each patient and thus improve the clinical response to pacing. Role diagnostic and prognostic for patients referred for evaluation of the risk of occurrence of a serious rhythm disorder or sudden death : The possibility to identify electrically abnormal areas either during the activation, or during cardiac repolarization with the high-resolution ECG is an indication of myocardial pathology that can be both unapparent on standard ECG and inaccessible to imaging techniques (ultrasound, CT or MRI). It is likely that such electrical anomalies are early diagnostic features of heart disease that will later be apparent. Such anomalies can also have an adverse prognostic weight (risk of arrhythmias or sudden death) that can be corrected if it is highlighted. Non-invasive mapping seems particularly important in patients with unexplained symptoms by conventional tests (palpitations or discomfort - syncope). It will also be applicable to patients with heart disease (myocardial infarction, cardiomyopathy) in search of localized electrical disorders that can be an originating site of arrhythmia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Rhythm Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
492 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 : Cardiac rythm radiofrequency ablation
Arm Type
Experimental
Arm Description
Prospective recruitment
Arm Title
Group 1: Implantation or programming of a pacemaker
Arm Type
Experimental
Arm Description
Prospective recruitment
Arm Title
Group 1: Risk of serious arrhythmias or sudden death
Arm Type
Experimental
Arm Description
Prospective recruitment
Arm Title
Group 2: Cardiac rythm radiofrequency ablation
Arm Type
Active Comparator
Arm Description
Retrospective recruitment
Arm Title
Group 2 : Implantation or programming of a pacemaker
Arm Type
Active Comparator
Arm Description
Retrospective recruitment
Arm Title
Group 2 : Risk of serious arrhythmias or sudden death
Arm Type
Active Comparator
Arm Description
Retrospective recruitment
Intervention Type
Device
Intervention Name(s)
Cardioinsight® mapping system
Intervention Type
Other
Intervention Name(s)
Conventional method without non-invasive mapping
Primary Outcome Measure Information:
Title
Arrhythmia termination during ablation guided by the Cardioinsight® mapping system
Time Frame
Day 1
Title
Variation of dP/dT measurement between baseline and after implantation or programmation of a pacemaker guided by the Cardioinsight® mapping system
Description
In mmHg/s
Time Frame
Day 1
Title
Measurement of the activation-recovery interval defined as the interval between a local depolarization time and repolarization time for patients referred for evaluation of the risk of occurrence of a serious rhythm disorder or sudden death
Description
In ms
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Arrhythmia recurrence at 1 year after ablation guided by the Cardioinsight® mapping system
Time Frame
Year 1
Title
For patients referred for implantation or programming of a pacemaker: Comparison of 6 Minutes Walk Test performed before and 6 months after implantation and/or programmation guided by the Cardioinsight® mapping system
Description
In meters
Time Frame
Month 6
Title
For patients referred for implantation or programming of a pacemaker: Comparison of left ventricular ejection fraction performed before and 6 months after implantation and/or programmation guided by the Cardioinsight® mapping system
Description
In percentage
Time Frame
Month 6
Title
Occurence of syncope, aborted sudden death or sudden death during follow-up for patients referred for evaluation of the risk of occurrence of a serious rhythm disorder or sudden death
Time Frame
Year 1, year 4 at most

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Oral agreement of the patient or of the holder of parental responsibility after reading the informed consent form. Patients with the following 3 conditions : Ablation of drugs rebels arrhythmias. Or implantation or programming of a pacemaker (pacemaker or defibrillator) Or symptoms and / or cardiopathy with risk of sudden death. Exclusion Criteria: Pregnancy and lactation. Patients unable to give oral agreement. Inconsistent patient's morphology with the establishment of the electrode jacket
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel HAÏSSAGUERRE, Pr
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France

12. IPD Sharing Statement

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Non-invasive Mapping of Rhythm Disorders

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