Cardioneuroablation for Variant Angina

NCT06992830 | Active Not Recruiting DMC

• 1 other identifier: 2025032
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Variant angina, also known as vasospastic angina, is a form of chest pain caused by temporary spasms of the coronary arteries, which reduce blood flow to the heart. These spasms often occur at rest and may lead to serious complications, including life-threatening heart rhythm problems and sudden cardiac death. While most patients improve with medications such as calcium channel blockers and nitrates, some continue to have symptoms despite treatment. In addition, some patients are unable or unwilling to take medications regularly, which further limits effective management. These cases are referred to as medication-refractory or drug-intolerant variant angina. The autonomic nervous system, which controls involuntary functions like heart rate and blood vessel tone, is believed to play an important role in the development of coronary artery spasms. Recent research suggests that imbalances in autonomic activity, particularly excessive parasympathetic signals, may trigger these spasms. Cardioneuroablation (CNA) is a minimally invasive procedure that uses a catheter to target specific nerve clusters called cardiac ganglionated plexi, located on the surface of the heart. These plexi are important centers of autonomic control and are mostly made up of parasympathetic nerve cells. Originally developed to treat conditions such as fainting spells and certain types of abnormal heart rhythms, CNA works by selectively reducing abnormal parasympathetic activity in the heart. This study is designed to explore whether CNA can help relieve chest pain and reduce coronary spasms in patients with variant angina who do not respond to medications or cannot take them consistently. The study will evaluate the safety, practicality, and potential benefits of this approach as a new treatment option for a difficult-to-manage heart condition.

Conditions

Variant Angina

Outcome Measures

Primary Outcomes (7)

• Change in Frequency of Coronary Spasm Episodes

  The number of coronary spasm episodes will be recorded before and after the procedure using 24-hour Holter ECG and integrated dynamic ECG device. Reduction in episode frequency will be used to evaluate treatment efficacy.

  Baseline and up to 6 months post-procedure

• Change in Angina Attack Frequency

  The frequency of chest pain episodes will be assessed through patient diaries and clinical interviews to evaluate symptom relief after treatment.

  Baseline and up to 6 months after treatment

• Severity of Coronary Spasms

  Severity will be assessed using imaging findings and clinical scoring systems, such as the Canadian Cardiovascular Society (CCS) Angina Grading Scale, to compare pre- and post-procedural status. CCS Angina Grading Scale ranges from Class I (least severe) to Class IV (most severe), with higher scores indicating worse angina severity. Additional imaging-based assessments (e.g., degree of coronary artery narrowing on angiography) will be qualitatively or semi-quantitatively described.

  Baseline and up to 6 months post-procedure

• Electrocardiographic Changes

  Standard 12-lead ECGs and 24-hour Holter monitoring will be analyzed for changes in ST-segment shifts and arrhythmias before and after the procedure.

  Baseline and up to 6 months

• Major Adverse Cardiovascular Events

  Incidence of cardiovascular events including arrhythmia, cardiac arrest, cardiac death, and acute myocardial infarction will be recorded during follow-up.

  From procedure until 6 months post-procedure

• Heart Rate Variability (HRV) Changes

  HRV parameters will be analyzed from 24-hour Holter ECG to assess autonomic modulation following ablation.

  Baseline and 1, 3, and 6 months post-treatment

• Requirement for Anti-Anginal Medications

  Dosage and frequency of anti-anginal drug use will be recorded to assess dependence on medication after CNA.

  Baseline and up to 6 months post-procedure

Secondary Outcomes (6)

• Acute Procedural Success Rate

  Intraoperative (immediate post-procedure)

• Incidence of Acute Procedural Complications

  Within 24 hours post-procedure

• Short-term Postoperative Complications

  Up to 30 days post-procedure

• Mid- to Long-Term Complications

  From 30 days to 12 months post-procedure

• Biomarker Monitoring (e.g., Cardiac Enzymes and Inflammatory Markers)

  Baseline and within 72 hours post-procedure

Study Arms (1)

Cardioneuroablation group

EXPERIMENTAL

Participants diagnosed with medication-refractory variant angina or those unable or unwilling to take medications regularly will undergo a catheter-based cardioneuroablation (CNA) procedure. CNA targets epicardial cardiac ganglionated plexi (GP), which are clusters of autonomic ganglia involved in parasympathetic modulation of cardiac function. The procedure is designed to reduce parasympathetic overactivity contributing to coronary artery spasms. Ablation will be performed using a radiofrequency catheter to eliminate GP areas identified by anatomical landmarks and electrophysiological mapping. No control or sham procedure is included in this single-arm study.

Procedure: cardioneuroablation

Interventions

cardioneuroablation PROCEDURE

Participants diagnosed with medication-refractory variant angina or those unable or unwilling to take medications regularly will undergo a catheter-based cardioneuroablation (CNA) procedure. CNA targets epicardial cardiac ganglionated plexi (GP), which are clusters of autonomic ganglia involved in parasympathetic modulation of cardiac function. The procedure is designed to reduce parasympathetic overactivity contributing to coronary artery spasms. Ablation will be performed using a radiofrequency catheter to eliminate GP areas identified by anatomical landmarks and electrophysiological mapping. No control or sham procedure is included in this single-arm study.

Cardioneuroablation group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 80 years;
• variant angina;
• positive ergonovine provocation test;
• refractory to antispasmodic drug therapy, or inability to achieve adequate symptom control due to drug intolerance, poor adherence, or unwillingness to take medications regularly.

You may not qualify if:

• cardiogenic shock;
• chronic heart failure;
• life expectancy less than 12 months;
• current participation in another clinical study without completing the primary endpoint visit; inability to provide informed consent;
• women of childbearing potential without effective contraception or who are breastfeeding;
• coronary artery stenosis ≥50% or FFR ≤0.80;
• sick sinus syndrome or high-degree AV block without pacemaker;
• systolic blood pressure \<90mmHg or heart rate \<50 bpm;
• allergy to diltiazem, nitrates, or nitroglycerin.

Sponsors & Collaborators

• Zhibing Lu: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

MeSH Terms

Conditions

Angina Pectoris, Variant

Condition Hierarchy (Ancestors)

Angina, Unstable; Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The chief of cardiology department

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 28, 2025
• Study Start: February 7, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-05

Locations

CN (1)