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Second Study on Cardio-neuromodulation in Humans (CardNMH2)

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ClinicalTrials.gov Identifier: NCT02954666
Recruitment Status : Recruiting
First Posted : November 3, 2016
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
Philippe Debruyne, Imelda Hospital, Bonheiden

Study Description
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Brief Summary:
Different approaches to cardio-neuroablation (CNA) to treat neurally mediated syncope, sinus node dysfunction, and functional atrioventricular block have been published. Investigators have developed a more limited and specific approach of CNA, called cardio-neuromodulation (CardNM). This treatment is based on a tailored vagolysis of the sinoatrial node through partial ablation of the anterior right ganglionated plexus (ARGP); it is also based on an innovative anatomic strategy. The feasibility of CardNM has already been tested in our center in a limited first study in humans (CardNMH1), with a favorable outcome for the patients involved. The results of CardNMH1 have been submitted for publication. The purpose of this second study of CardNM in humans (CardNMH2) is to collect more procedural and clinical data in well-defined patient groups.

Condition or disease Intervention/treatment Phase
Cardiac Disease Syncope Syncope, Vasovagal Sick Sinus Syndrome Device: radio-frequency ablation (nMARQ™ or Smart Touch™ catheter) Phase 2

Detailed Description:
This is a phase II A prospective, interventional study. All patients will undergo CardNM. The study will involve eight different steps, from the screening procedure through study completion: screening, enrollment, pharmacological testing, group allocation, preprocedural assessment, procedure, follow-up, study completion.The dedicated study nurse and the PI are responsible for recording all data from the trial on the case report forms (CRFs) and completing the study database. A dedicated independent physician will be responsible for the safety monitoring. The PI will permit inspection of the trial files and the database by national or international official controlling scientific authorities, if required. The PI will review and monitor completed CRFs and the database at regular intervals throughout the trial.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Second Study on Cardio-neuromodulation in Humans
Study Start Date : December 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting

Arms and Interventions
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Arm Intervention/treatment
Experimental: Patients with neurally mediated syncope
Tailored radio-frequency ablation of the ARGP (CardNM).
 Device: radio-frequency ablation (nMARQ™ or Smart Touch™ catheter)

Patients will undergo a tailored radio-frequency ablation of the ARGP with the Smart Touch™ catheter or with the nMARQ™ catheter. Radiofrequency applications will be interrupted if no significant P-P interval shortening is observed after 30 seconds or if P-P interval is ≤ 550 ms during ablation.

The ablation procedure is considered complete when one of the following conditions is fulfilled:

P-P interval < 70% baseline procedural P-P interval after 5minute of waiting time; P-P interval < 600 ms after 5 minute of waiting time; 5 radiofrequency applications > 30 seconds have been delivered with the nMARQ™ catheter or 10 applications with the Smart Touch catheter.

Other Name: cardio-neuromodulation, cardio-neuroablation, ARGP
Experimental: Patients with sick sinus syndrome
Tailored radio-frequency ablation of the ARGP (CardNM).
 Device: radio-frequency ablation (nMARQ™ or Smart Touch™ catheter)

Patients will undergo a tailored radio-frequency ablation of the ARGP with the Smart Touch™ catheter or with the nMARQ™ catheter. Radiofrequency applications will be interrupted if no significant P-P interval shortening is observed after 30 seconds or if P-P interval is ≤ 550 ms during ablation.

The ablation procedure is considered complete when one of the following conditions is fulfilled:

P-P interval < 70% baseline procedural P-P interval after 5minute of waiting time; P-P interval < 600 ms after 5 minute of waiting time; 5 radiofrequency applications > 30 seconds have been delivered with the nMARQ™ catheter or 10 applications with the Smart Touch catheter.

Other Name: cardio-neuromodulation, cardio-neuroablation, ARGP


Outcome Measures
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Primary Outcome Measures :
  1. freedom from syncope [ Time Frame: 12 months ]
  2. freedom from serious adverse event [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. freedom from pre syncope [ Time Frame: 12 months ]

Other Outcome Measures:
  1. quantification of the vagolysis of the sinus node [ Time Frame: procedure, 1,3,6,12 months ]
    The quantification of vagolysis of the sinus node obtained during CardNM will be evaluated by automatic P-P interval measurements during procedure, by ECG derived and standardized P-P interval measurements and by automatical quantification of P-P interval histograms on Holter registrations before procedure and during FU.


Eligibility Criteria
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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Candidates must meet all of the inclusion criteria required for inclusion in one of the two groups (summarized in Table 2). All of the patients need to have a positive P wave of > 0.5 mm in lead 2. Patients must have had ≥ 1 syncope during the 6 months preceding enrollment and ≥ 2 syncopes in their lifetime except if the last syncope was complicated by an injury or an accident, in which case further waiting for CardNM may be less desirable. Patients < 18 years must have least 3 syncopes with an interval exceeding 1 month unless 1 syncope was complicated by an injury or an accident.

If a significant rate drop (> 15%) is noted during head-up tilt test (HUT), either isolated or combined with vasoplegia, and associated with syncope or severe presyncope, patients will be eligible for inclusion in group A. If the HUT is negative and a pause > 3 seconds has been documented, patients will be assigned to group B. If both conditions are present, patients will be eligible for inclusion in either group but will be preferentially assigned to group A.

Exclusion Criteria:

Candidates will be excluded if ANY of the following criteria apply (detailed in Table 3):

  • < 14 years of age;
  • Inability to provide consent;
  • Chronotropic negative medications (excepted in patients with a previous history of atrial fibrillation);
  • 4 g amiodarone intake during the 2 months preceding enrollment;
  • Alternating right bundle branch block (RBBB) and left bundle branch block (LBBB), HV interval > 70 ms;
  • LBBB, bifascicular block (RBBB + left anterior hemiblock [LAHB], RBBB + left posterior hemiblock [LPHB]);
  • PR interval permanently > 240 ms;
  • Permanent AF, PAF or electrical cardioversion during the last 6 months;
  • Valvular or subvalvular aortic stenosis, mitral stenosis;
  • Any unstable medical condition, life expectancy < 12 months;
  • Syncopes due a non-cardiac disease (excepted NMS) or advanced neuropathy;
  • Current pregnancy;
  • glaucoma.

Patients with transient atrioventricular conduction disturbances and normal atrioventricular conduction during an exercise test and normal QRS complexes are eligible for this study.

Patients with a high risk of bleeding are eligible, but clopidogrel (75 mg daily, 1 month of treatment) will then be preferred to oral anticoagulants.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02954666


Contacts
Contact: Philippe Debruyne, MD 0032478229896 philippe.debruyne@skynet.be
Contact: Margareta Badts, study nurse 003215514114 Margareta.Badts@imelda.be

Locations
Belgium
Imeldaziekenhuis Recruiting
Bonheiden, Antwerpen, Belgium, 2820
Contact: Margareta Badts, study nurse    003215504714    Margareta.Badts@imelda.be   
Contact: Philippe Debruyne, MD       philippe.debruyne@skynet.be   
Principal Investigator: Philippe Debruyne, MD         
Sponsors and Collaborators
Imelda Hospital, Bonheiden
Investigators
Principal Investigator: Philippe Debruyne, MD Imeldahospital
More Information
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Publications:

Responsible Party: Philippe Debruyne, Principal investigator (PI), Head of Electrophysiology, Imelda Hospital, Bonheiden
ClinicalTrials.gov Identifier: NCT02954666     History of Changes
Other Study ID Numbers: B689201629811
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Philippe Debruyne, Imelda Hospital, Bonheiden:
cardio-neuromodulation
cardio-neuroablation
ablation
 ganglionated plexi
anterior right ganglionated plexus
syncope

Additional relevant MeSH terms:
Syncope
Heart Diseases
Sick Sinus Syndrome
Syncope, Vasovagal
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
 Signs and Symptoms
Cardiovascular Diseases
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Block
Pathologic Processes
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases