Cardioneuroablation for Variant Angina

NCT ID: NCT06992830

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-07
• Study Completion Date: 2027-02-28

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cardioneuroablation group

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.

Group Type: EXPERIMENTAL

cardioneuroablation

Intervention Type: 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.

Interventions

cardioneuroablation

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhibing Lu

OTHER

Sponsor Role: lead

Responsible Party

Zhibing Lu

The chief of cardiology department

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Countries

China

Other Identifiers

2025032

Identifier Type: -

Identifier Source: org_study_id