Second Study on Cardio-neuromodulation in Humans

NCT02954666 | Completed DMC

• 1 other identifier: B689201629811
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Disease; Syncope; Syncope, Vasovagal; Sick Sinus Syndrome

Keywords

cardio-neuromodulation; cardio-neuroablation; ablation; ganglionated plexi; anterior right ganglionated plexus; syncope

Outcome Measures

Primary Outcomes (2)

• freedom from syncope

  12 months

• freedom from serious adverse event

  7 days

Secondary Outcomes (1)

• freedom from pre syncope

  12 months

Other Outcomes (1)

• quantification of the vagolysis of the sinus node

  procedure, 1,3,6,12 months

Study Arms (2)

Patients with neurally mediated syncope

EXPERIMENTAL

Tailored radio-frequency ablation of the ARGP (CardNM).

Device: radio-frequency ablation

Patients with sick sinus syndrome

EXPERIMENTAL

Tailored radio-frequency ablation of the ARGP (CardNM).

Device: radio-frequency ablation

Interventions

radio-frequency ablation DEVICE

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.

Also known as: cardio-neuromodulation, cardio-neuroablation, ARGP

Patients with neurally mediated syncope; Patients with sick sinus syndrome

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Imelda Hospital, Bonheiden: lead

Study Sites (1)

Imeldaziekenhuis

Bonheiden, Antwerpen, 2820, Belgium

Location

Related Publications (3)

• Debruyne P. "Cardio-Neuromodulation" With a Multielectrode Irrigated Catheter: A Potential New Approach for Patients With Cardio-Inhibitory Syncope. J Cardiovasc Electrophysiol. 2016 Sep;27(9):1110-3. doi: 10.1111/jce.13031. Epub 2016 Aug 1.

  PMID: 27307200 BACKGROUND

• Debruyne P, Rossenbacker T, Janssens L, Collienne C, Ector J, Haemers P, le Polain de Waroux JB, Bazelmans C, Boussy T, Wijns W. Durable Physiological Changes and Decreased Syncope Burden 12 Months After Unifocal Right-Sided Ablation Under Computed Tomographic Guidance in Patients With Neurally Mediated Syncope or Functional Sinus Node Dysfunction. Circ Arrhythm Electrophysiol. 2021 Jun;14(6):e009747. doi: 10.1161/CIRCEP.120.009747. Epub 2021 May 17.

  PMID: 33999698 DERIVED

• Debruyne P, Rossenbacker T, Collienne C, Roosen J, Ector B, Janssens L, Charlier F, Vankelecom B, Dewilde W, Wijns W. Unifocal Right-Sided Ablation Treatment for Neurally Mediated Syncope and Functional Sinus Node Dysfunction Under Computed Tomographic Guidance. Circ Arrhythm Electrophysiol. 2018 Sep;11(9):e006604. doi: 10.1161/CIRCEP.118.006604.

  PMID: 30354289 DERIVED

MeSH Terms

Conditions

Heart Diseases; Syncope; Syncope, Vasovagal; Sick Sinus Syndrome

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Block; Cardiac Conduction System Disease; Pathologic Processes

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Philippe Debruyne, MD

  Imeldahospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator (PI), Head of Electrophysiology

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 3, 2016
• Study Start: December 10, 2016
• Primary Completion: April 1, 2020
• Study Completion: May 11, 2020
• Last Updated: January 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)