Comparing Cardioneuroablation and Midodrine for Vasovagal Syncope Treatment

Effect of Cardioneuroablation vs Midodrine on Syncope Recurrence Among Patients With Vasovagal Syncope: The CAMPAIGN Randomized Clinical Trial

This study is testing whether a procedure called Cardioneuroablation works better than the medication Midodrine to help adults with frequent fainting spells caused by vasovagal syncope.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 184 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: China National Center for Cardiovascular Diseases (other gov)
• Locations: 1 site (Beijing)
• Trial ID: NCT05803148 on ClinicalTrials.gov

What this trial studies

This international, multi-center trial aims to evaluate the effectiveness of Cardioneuroablation (CNA) compared to the drug Midodrine in preventing syncope recurrence in patients with moderate to severe vasovagal syncope (VVS). The study will include adults who have experienced frequent syncope episodes and have not responded to non-pharmacologic treatments. Participants will be randomly assigned to receive either CNA or Midodrine, with follow-up assessments to determine the rate of syncope recurrence. The trial seeks to provide robust evidence on the best treatment strategy for VVS.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have experienced more than three syncope episodes in the past year and have not benefited from non-pharmacologic treatments.

Not a fit: Patients with syncope caused by other medical conditions, such as postural hypotension or cardiac arrhythmias, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the frequency of syncope episodes and improve the quality of life for patients suffering from vasovagal syncope.

How similar studies have performed: Previous studies have shown promising results for Cardioneuroablation in preventing syncope, indicating that this approach may be effective, though this trial aims to provide more definitive evidence through a randomized control design.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years of age
2. Calgary Syncope Symptom Score ≥ -2 points
3. Positive response to head-up tilt test
4. With syncope episodes more than 3 times in the preceding year
5. 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
6. Willingness to comply with follow-up requirements and to sign the informed consent

Exclusion Criteria:

1. 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.
2. Complied with congenital heart disease, valvular heart disease, cardiomyopathy, and diabetes.
3. History of cardiac catheter ablation, peacemaker implantation and cardiac surgery.
4. History of midodrine usage, or compiled with contradiction of midodrine, including urine retention, hypertension (Bp≥140/90mmHg), glaucoma， renal dysfunction.
5. Life expectancy \<1 year for any medical condition
6. Pregnancy or breast-feeding

Where this trial is running

Beijing

• Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: yan Yao, PhD

Conditions: Syncope, Vasovagal, Vasovagal syncope, Cardioneuroablation, Midodrine