Non-invasive Mapping of Rhythm Disorders

NCT02647749 | Completed

• 1 other identifier: CHUBX 2015/01
• Study Type: interventional
• Target: 492
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Rhythm Disorders

Outcome Measures

Primary Outcomes (3)

• Arrhythmia termination during ablation guided by the Cardioinsight® mapping system

  Day 1

• Variation of dP/dT measurement between baseline and after implantation or programmation of a pacemaker guided by the Cardioinsight® mapping system

  In mmHg/s

  Day 1

• 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

  Day 1

Secondary Outcomes (4)

• Arrhythmia recurrence at 1 year after ablation guided by the Cardioinsight® mapping system

  Year 1

• 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

  Month 6

• 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

  Month 6

• 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

  Year 1, year 4 at most

Study Arms (6)

Group 1 : Cardiac rythm radiofrequency ablation

EXPERIMENTAL

Prospective recruitment

Device: Cardioinsight® mapping system

Group 1: Implantation or programming of a pacemaker

EXPERIMENTAL

Prospective recruitment

Device: Cardioinsight® mapping system

Group 1: Risk of serious arrhythmias or sudden death

EXPERIMENTAL

Prospective recruitment

Device: Cardioinsight® mapping system

Group 2: Cardiac rythm radiofrequency ablation

ACTIVE COMPARATOR

Retrospective recruitment

Other: Conventional method without non-invasive mapping

Group 2 : Implantation or programming of a pacemaker

ACTIVE COMPARATOR

Retrospective recruitment

Other: Conventional method without non-invasive mapping

Group 2 : Risk of serious arrhythmias or sudden death

ACTIVE COMPARATOR

Retrospective recruitment

Other: Conventional method without non-invasive mapping

Interventions

Cardioinsight® mapping system DEVICE

Group 1 : Cardiac rythm radiofrequency ablation; Group 1: Implantation or programming of a pacemaker; Group 1: Risk of serious arrhythmias or sudden death

Conventional method without non-invasive mapping OTHER

Group 2 : Implantation or programming of a pacemaker; Group 2 : Risk of serious arrhythmias or sudden death; Group 2: Cardiac rythm radiofrequency ablation

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33000, France

Location

Related Publications (1)

• Zhang J, Hocini M, Strom M, Cuculich PS, Cooper DH, Sacher F, Haissaguerre M, Rudy Y. The Electrophysiological Substrate of Early Repolarization Syndrome: Noninvasive Mapping in Patients. JACC Clin Electrophysiol. 2017 Aug;3(8):894-904. doi: 10.1016/j.jacep.2016.12.017.

  PMID: 29130071 RESULT

Study Officials

• Michel HAÏSSAGUERRE, Pr

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: January 6, 2016
• Study Start: May 19, 2015
• Primary Completion: May 1, 2019
• Study Completion: May 28, 2020
• Last Updated: May 14, 2026

Record last verified: 2022-02

Locations

FR (1)