Cardioinhibitory Reflex Syncope. Permanent Pacemaker Therapy or Cardioneuroablation?

NCT05855603 | Recruiting DMC

• 1 other identifier: ICPS044/22
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 10

Brief Summary

Reflex syncope is the most common form of syncope. It can lead to injuries and affect quality of life. Nonpharmacological and medical therapies have limited effectiveness. In certain patients, cardiac pacing seem to be beneficial. More recently cardioneuroablation (CNA) has emerged as a novel therapy for reflex syncope. The investigators aim to determine whether CNA is more effective than cardiac pacing at reducing the rate of cardioinhibitory-type reflex syncope.

Conditions

Reflex Syncope

Keywords

Cardioneuroablation; Permanent cardiac pacing; Vasovagal syncope

Outcome Measures

Primary Outcomes (1)

• To determine the efficacy of CNA in the treatment of cardioinhibitory reflex syncope in comparison to pacemaker therapy.

  Differences in 12-month syncope-free survival between the 2 groups

  12 months

Secondary Outcomes (7)

• To evaluate the incidence of complications in the short and long terms for CNA compared to pacemaker therapy

  1 and 12 months

• In patients undergoing CNA, evaluation of the degree of long-term reinnervation using the tilt table test (HUTT)

  1 and 12 months

• In patients undergoing CNA, evaluation of the degree of long-term reinnervation using the atropine test

  1 and 12 months

• To determine which of the 2 strategies, CNA or cardiac pacing, is superior at preventing a composite of syncope and presyncope

  12 months

• Evaluations of changes in quality of life, comparing the two therapies

  12 months

Study Arms (2)

Cardioneuroablation

EXPERIMENTAL

Bi-atrial ablation of GPs: CARDIONEUROABLATION (Group A, n = 45)

Procedure: Cardioneuroablation

Dual-chamber pacemaker

ACTIVE COMPARATOR

Implant of a dual-chamber CLS PACEMAKER\* (Group B, n = 45). \*or failing this, a dual-chamber pacemaker with RDR algorithm

Device: Permanent pacemaker therapy

Interventions

Cardioneuroablation PROCEDURE

Ganglionated plexi will be localized using an empirical anatomical approach and/or a fractionated electrogram-based strategy. Point-by-point ablation will be performed using radiofrequency energy and an irrigated tip contact force sensing ablation catheter in a power control mode (35-50 W; AI, 350-500; LSI, 4.5-5.5). The right superior GP (RSGP), left superior GP (LSGP) and posterior left GP (PMLGP) will be targeted during CNA. Radiofrequency applications in other GPs will be left at the discretion of the operator. At the end of the procedure, another EP study and atropine test will be performed. Clinical endpoints for completion of the CNA will be: 1) a HR increase \>20% if the CNA was performed under general anesthesia/deep sedation; 2) improved electrophysiological parameters; 3) significant reduction in atropine response (HR increase \<10% after atropine); and 4) in case of using extracardiac vagal stimulation, lack of response.

Cardioneuroablation

Permanent pacemaker therapy DEVICE

All patients in the pacemaker group will receive a dual-chamber pacemaker that has the ability to be programmed in the DDD-CLS algorithm mode (or failing this, a dual-chamber pacemaker with RDR algorithm).

Dual-chamber pacemaker

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged more than 40 years.
• Having a 12-month history that includes at least two documented episodes of spontaneous reflex syncope or one episode that led to injury in addition to at least two presyncopal events, refractory to all recommended types of standard treatment.
• Bradycardia-syncope correlation (at least 3 seconds of asystole due to sinus arrest or atrio-ventricular block) confirmed by ECG during spontaneous syncope.
• If lacking ECG evidence during spontaneous syncope, a cardioinhibitory response (VASIS type 2A or 2B) on tilt test.
• Displaying indicators for pacing such as those suggested in the ESC guidelines for a class I recommendation for patients with reflex syncope.
• Significantly decreased quality of life due to syncope.
• Sinus rhythm on ECGs.
• Obtained written informed consent.

You may not qualify if:

• Intrinsic sinus or atrioventricular nodal disease with a proven indication for permanent pacemaker implantation.
• Evidence of structural heart disease.
• Contraindications to ablation in the right or left atrium.
• Life expectancy \<12 months.
• Lacking willingness to comply with the randomization procedure.

Sponsors & Collaborators

• Institut d'Investigació Biomèdica de Bellvitge: lead

Study Sites (10)

Hospital Universitario San Juan de Alicante

Sant Joan d'Alacant, Alicante, 03550, Spain

NOT YET RECRUITING

Hospital Universitari General de Castellón

Castellon, Castellón, 12004, Spain

NOT YET RECRUITING

Hospital Universitario Álvaro Cunqueiro de Vigo

Vigo, Pontevedra, 36312, Spain

NOT YET RECRUITING

Hospital del Mar

Barcelona, 08003, Spain

NOT YET RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

NOT YET RECRUITING

Hospital Universitario de Bellvitge

Barcelona, 08907, Spain

RECRUITING

Hospital Universitari Dr. Josep Trueta

Girona, 17007, Spain

NOT YET RECRUITING

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, 38010, Spain

NOT YET RECRUITING

Hospital Universitari i Politècnic La Fe

Valencia, 46026, Spain

NOT YET RECRUITING

Hospital Clínico Universitario Lozano Blesa

Zaragoza, 50009, Spain

NOT YET RECRUITING

Related Publications (3)

• Pachon JC, Pachon EI, Cunha Pachon MZ, Lobo TJ, Pachon JC, Santillana TG. Catheter ablation of severe neurally meditated reflex (neurocardiogenic or vasovagal) syncope: cardioneuroablation long-term results. Europace. 2011 Sep;13(9):1231-42. doi: 10.1093/europace/eur163. Epub 2011 Jun 28.

  PMID: 21712276 RESULT

• Aksu T, Gupta D, D'Avila A, Morillo CA. Cardioneuroablation for vasovagal syncope and atrioventricular block: A step-by-step guide. J Cardiovasc Electrophysiol. 2022 Oct;33(10):2205-2212. doi: 10.1111/jce.15480. Epub 2022 Apr 9.

  PMID: 35362165 RESULT

• Piotrowski R, Baran J, Sikorska A, Krynski T, Kulakowski P. Cardioneuroablation for Reflex Syncope: Efficacy and Effects on Autonomic Cardiac Regulation-A Prospective Randomized Trial. JACC Clin Electrophysiol. 2023 Jan;9(1):85-95. doi: 10.1016/j.jacep.2022.08.011. Epub 2022 Aug 28.

  PMID: 36114133 RESULT

MeSH Terms

Conditions

Syncope, Vasovagal

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Syncope; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rodolfo San Antonio, MD, PhD

  Hospital Universitario de Bellvitge

  STUDY CHAIR

Central Study Contacts

Rodolfo San Antonio, MD, PhD

CONTACT

932607500; rsanantonio@bellvitgehospital.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 11, 2023
• Study Start: November 22, 2023
• Primary Completion (Estimated): November 22, 2026
• Study Completion (Estimated): February 22, 2027
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (10)