Second Study on Cardio-neuromodulation in Humans (CardNMH2)
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ClinicalTrials.gov Identifier: NCT02954666 |
Recruitment Status : Unknown
Verified December 2016 by Philippe Debruyne, Imelda Hospital, Bonheiden.
Recruitment status was: Recruiting
First Posted : November 3, 2016
Last Update Posted : January 4, 2017
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Condition or disease | Intervention/treatment | Phase |
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Cardiac Disease Syncope Syncope, Vasovagal Sick Sinus Syndrome | Device: radio-frequency ablation (nMARQ™ or Smart Touch™ catheter) | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Patients with neurally mediated syncope
Tailored radio-frequency ablation of the ARGP (CardNM).
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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 |
- freedom from syncope [ Time Frame: 12 months ]
- freedom from serious adverse event [ Time Frame: 7 days ]
- freedom from pre syncope [ Time Frame: 12 months ]
- 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.

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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 |
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.

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
Contact: Philippe Debruyne, MD | 0032478229896 | philippe.debruyne@skynet.be | |
Contact: Margareta Badts, study nurse | 003215514114 | Margareta.Badts@imelda.be |
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 |
Principal Investigator: | Philippe Debruyne, MD | Imeldahospital |
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 |