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Second Study on Cardio-neuromodulation in Humans (CardNMH2)

Primary Purpose

Cardiac Disease, Syncope, Syncope, Vasovagal

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

radio-frequency ablation

About this trial

This is an interventional treatment trial for Cardiac Disease focused on measuring cardio-neuromodulation, cardio-neuroablation, ablation, ganglionated plexi, anterior right ganglionated plexus, syncope

Eligibility Criteria

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

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.

Sites / Locations

Imeldaziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Patients with neurally mediated syncope

Patients with sick sinus syndrome

Arm Description

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

Outcomes

Primary Outcome Measures

freedom from syncope

freedom from serious adverse event

Secondary Outcome Measures

freedom from pre syncope

Full Information

NCT ID

NCT02954666

First Posted

November 2, 2016

Last Updated

January 19, 2021

Sponsor

Imelda Hospital, Bonheiden

1. Study Identification

Unique Protocol Identification Number

NCT02954666

Brief Title

Second Study on Cardio-neuromodulation in Humans

Acronym

CardNMH2

Official Title

Second Study on Cardio-neuromodulation in Humans

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

December 10, 2016 (Actual)

Primary Completion Date

April 1, 2020 (Actual)

Study Completion Date

May 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Imelda Hospital, Bonheiden

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

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

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients with neurally mediated syncope

Arm Type

Experimental

Arm Description

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

Arm Title

Patients with sick sinus syndrome

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

radio-frequency ablation

Other Intervention Name(s)

cardio-neuromodulation, cardio-neuroablation, ARGP

Intervention Description

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.

Primary Outcome Measure Information:

Title

freedom from syncope

Time Frame

12 months

Title

freedom from serious adverse event

Time Frame

7 days

Secondary Outcome Measure Information:

Title

freedom from pre syncope

Time Frame

12 months

Other Pre-specified Outcome Measures:

Title

quantification of the vagolysis of the sinus node

Description

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.

Time Frame

procedure, 1,3,6,12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philippe Debruyne, MD

Organizational Affiliation

Imeldahospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Imeldaziekenhuis

City

Bonheiden

State/Province

Antwerpen

ZIP/Postal Code

2820

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27307200

Citation

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.

Results Reference

background

PubMed Identifier

33999698

Citation

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.

Results Reference

derived

PubMed Identifier

30354289

Citation

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.

Results Reference

derived

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Second Study on Cardio-neuromodulation in Humans

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