Second Study on Cardio-neuromodulation in Humans

NCT ID: NCT02954666

Last Updated: 2021-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-10
• Study Completion Date: 2020-05-11

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.

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with neurally mediated syncope

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

Group Type: EXPERIMENTAL

radio-frequency ablation

Intervention Type: 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.

Patients with sick sinus syndrome

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

Group Type: EXPERIMENTAL

radio-frequency ablation

Intervention Type: 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.

Interventions

radio-frequency ablation

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.

Intervention Type: DEVICE

Other Intervention Names

cardio-neuromodulation, cardio-neuroablation, ARGP

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imelda Hospital, Bonheiden

OTHER

Sponsor Role: lead

Responsible Party

Philippe Debruyne

Principal investigator (PI), Head of Electrophysiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philippe Debruyne, MD

Role: PRINCIPAL_INVESTIGATOR

Imeldahospital

Locations

Imeldaziekenhuis

Bonheiden, Antwerpen, Belgium

Countries

Belgium

References

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.

Reference Type: BACKGROUND

PMID: 27307200 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33999698 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30354289 (View on PubMed)

Other Identifiers

B689201629811

Identifier Type: -

Identifier Source: org_study_id