NCT05803148

Brief Summary

This is a prospective, international multi-center, open-labeled, randomized trial. The investigator speculated that CNA prevents more patients with moderate to severe VVS from syncope recurrence compared to midodrine.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

April 5, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 7, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

1.7 years

First QC Date

March 9, 2023

Last Update Submit

March 20, 2024

Conditions

Syncope, Vasovagal

Keywords

Vasovagal syncopeCardioneuroablationMidodrine

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with syncope recurrence during follow-up

    Syncope was defined as a transient loss of consciousness and complete recovery in a very short time.

    12 month after randomization

Secondary Outcomes (6)

  • Number of Participants with pre-syncope during follow-up

    12 month after randomization

  • Quality of life measure by Impact of Syncope on Quality of Life（ISQL）questionnaire

    6 month after randomization

  • Quality of life measure by Impact of Syncope on Quality of Life（ISQL）questionnaire

    12 month after randomization

  • Results of Head-up tilt test

    12 month after randomization

  • Blood pressure measured with 24 hours monitoring

    6 month after randomization

  • +1 more secondary outcomes

Study Arms (2)

Experimental group: Cardioneuroablation

EXPERIMENTAL

In this arm, the catheter ablation of the GPs will be performed in the order of LSGP, LIGP, RIGP, left atrial RAGP and right atrial RAGP. Patient education includes fully informing patients of the benign prognosis of vasovagal syncope, and educating patients to avoid triggering factors as much as possible. At the same time, the patient should be taught how to cope with the impending syncope with physical counter-pressure maneuvers and dietary suggestions that emphasize fluid and sodium intake.

Procedure: Cardioneuroablation

Control group: Midodrine

ACTIVE COMPARATOR

In this arm, Midodrine will be applied without the following contraindications: hypertension, chromaffin cell carcinoma, acute nephritis, severe renal dysfunction, glaucoma, prostatic hyperplasia with urinary retention, mechanical urinary obstruction, hyperthyroidism. Patient education includes fully informing patients of the benign prognosis of vasovagal syncope, and educating patients to avoid triggering factors as much as possible. At the same time, the patient should be taught how to cope with the impending syncope with physical counter-pressure maneuvers and dietary suggestions that emphasize fluid and sodium intake.

Drug: Midodrine Oral Tablet

Interventions

CardioneuroablationPROCEDURE

The left atrium model was established under the guidance of three-dimensional mapping. Atrial septum puncture、left atrium mapping and right atrium mapping will be performed according to standard EP lab protocol. The location of GPs will be detected with HAFE potential (duration ≥ 50ms， deflections ≥ 4 times， amplitude ≥ 0.7mV) and high frequency stimulation (HFS; 30 Hz, 20 mV, pulse width 2ms) through positive vasovagal response (transient ventricular asystole, atrioventricular block, or R-R interval increased by 30%) . Saline Irrigated-tip catheter with pressure monitoring will be applied for the procedure, and radiofrequency energy is limited to 40W and 43℃ for at least 30s at each site. The ablation endpoint for each GP is defined as the complete elimination of all targeted HAFE potential and elimination of positive vasovagal response. The endpoint of the procedure was that the heart rate reach 75% of the maximum heart rate in atropine test.

Also known as: Cardiac ganglion plexus ablation
Experimental group: Cardioneuroablation
Midodrine Oral TabletDRUG

Midodrine will start dosing with 5 mg of the study drug 3 times daily, 4 hours apart, during daylight hours.Dose with be adjusted within a range of 2.5 mg twice daily, 4 hours apart, up to 10 mg, 3 times daily, every 4 hours. The optimal dose ranging be completed within the first 2 weeks. If intolerable symptoms persisted despite dose reductions, the drug will be withdrawn, and the patient was released from the study.

Also known as: Midodrine pill
Control group: Midodrine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years of age
  • Calgary Syncope Symptom Score ≥ -2 points
  • Positive response to head-up tilt test
  • With syncope episodes more than 3 times in the preceding year
  • A proven failure of non-pharmacologic treatment, including reassurance regarding the benign prognosis, education about the avoidance of situations and triggers initiating syncope， application of PCM during the occurrence of prodromal symptoms, and lifestyle modifications（adequate fluid intake and salt supplementation）， according to the guideline
  • Willingness to comply with follow-up requirements and to sign the informed consent

You may not qualify if:

  • Complied with other causes of syncope, including postural hypotension, aortic stenosis, sick sinus node syndrome, high-grade atrioventricular block, ventricular arrhythmias, pulmonary hypertension, hypertrophic cardiomyopathy, transient ischemic attack, epilepsy, sequelae of cerebral infarction or cerebral hemorrhage, subclavian vein steal syndrome and drug-induced syncope.
  • Complied with congenital heart disease, valvular heart disease, cardiomyopathy, and diabetes.
  • History of cardiac catheter ablation, peacemaker implantation and cardiac surgery.
  • History of midodrine usage, or compiled with contradiction of midodrine, including urine retention, hypertension (Bp≥140/90mmHg), glaucoma， renal dysfunction.
  • Life expectancy \<1 year for any medical condition
  • Pregnancy or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

RECRUITING

Related Publications (4)

  • Tu B, Wu L, Hu F, Fan S, Liu S, Liu L, Ding L, Zheng L, Yao Y. Cardiac deceleration capacity as an indicator for cardioneuroablation in patients with refractory vasovagal syncope. Heart Rhythm. 2022 Apr;19(4):562-569. doi: 10.1016/j.hrthm.2021.12.007. Epub 2021 Dec 9.

    PMID: 34896621RESULT

  • Sheldon R, Faris P, Tang A, Ayala-Paredes F, Guzman J, Marquez M, Morillo CA, Krahn AD, Kus T, Ritchie D, Safdar S, Maxey C, Raj SR; POST 4 investigators. Midodrine for the Prevention of Vasovagal Syncope : A Randomized Clinical Trial. Ann Intern Med. 2021 Oct;174(10):1349-1356. doi: 10.7326/M20-5415. Epub 2021 Aug 3.

    PMID: 34339231RESULT

  • Hu F, Zheng L, Liang E, Ding L, Wu L, Chen G, Fan X, Yao Y. Right anterior ganglionated plexus: The primary target of cardioneuroablation? Heart Rhythm. 2019 Oct;16(10):1545-1551. doi: 10.1016/j.hrthm.2019.07.018. Epub 2019 Jul 19.

    PMID: 31330187RESULT

  • Maimaitijiang P, Tu B, Lai Z, Chen A, Zhang Z, Zhou L, Cai S, Zheng L, Yao Y; CAMPAIGN Investigators. The Efficacy of Cardioneuroablation versus Midodrine in Patients with Vasovagal Syncope: Design and Rationale for the CAMPAIGN Trial. J Interv Card Electrophysiol. 2025 Mar;68(2):257-265. doi: 10.1007/s10840-025-02029-4. Epub 2025 Mar 21.

    PMID: 40117099DERIVED

MeSH Terms

Conditions

Syncope, Vasovagal

Interventions

Midodrine

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesSyncopeUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Officials

  • yan Yao, PhD

    Fuwai Hospital, National Center for Cardiovascular Diseases

    STUDY CHAIR

Central Study Contacts

yan Yao, PhD

CONTACT

13901121319ianyao@263.net.cn

lihui Zheng, PhD

CONTACT

13910617612zhenglihui@263.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of First Department of Arrythmia Center

Study Record Dates

First Submitted

March 9, 2023

First Posted

April 7, 2023

Study Start

April 5, 2023

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

March 21, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)