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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
Sponsored by
Imelda Hospital, Bonheiden
About
Eligibility
Locations
Arms
Outcomes
Full info

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

Experimental

Arm Label

Patients with neurally mediated syncope

Patients with sick sinus syndrome

Arm Description

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

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

First Posted
November 2, 2016
Last Updated
January 19, 2021
Sponsor
Imelda Hospital, Bonheiden
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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
No
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
No
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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