Variant AnginaNCT06992830

Cardioneuroablation for Variant Angina

A study testing cardioneuroablation in people with Variant Angina, run by Zhibing Lu at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Variant Angina
What is being tested?: cardioneuroablation
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteChina
Study dates: 7 Feb 2025to 28 Feb 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 9Show fewer

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071

Other trials in China

About this study

Official title: Cardioneuroablation of Atrial Ganglionated Plexi in Patients With Variant Angina

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
Being tested: cardioneuroablation
Medical subject headings: Angina Pectoris, Variant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

cardioneuroablationProcedure or surgery
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.

Study groups in NCT06992830
Study group	Role	What they receive
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. Receives: Procedure: cardioneuroablation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and up to 6 months post-procedure

Secondary outcomes (6)

Acute Procedural Success Rate
Defined as successful identification and ablation of ganglionated plexi without intraoperative complications.
Measured: Intraoperative (immediate post-procedure)
Incidence of Acute Procedural Complications
Includes intraoperative events such as vascular injury, pericardial effusion, and procedural arrhythmias.
Measured: Within 24 hours post-procedure
Short-term Postoperative Complications
Includes post-procedural complications such as bleeding, infection, and arrhythmias.
Measured: Up to 30 days post-procedure
Mid- to Long-Term Complications
Includes recurrence of coronary spasm, new myocardial infarction, and worsening of cardiac function.
Measured: From 30 days to 12 months post-procedure
Biomarker Monitoring (e.g., Cardiac Enzymes and Inflammatory Markers)
Serum levels of specific biomarkers will be measured to evaluate myocardial injury and systemic inflammation. These include cardiac enzymes (e.g., troponin I/T, CK-MB) and inflammatory markers (e.g., C-reactive protein [CRP], interleukin-6 [IL-6]). Blood samples will be collected at baseline and within 72 hours post-ablation. Levels will be quantified using standard laboratory assays, and changes will be compared to evaluate procedure-related biological responses.
Measured: Baseline and within 72 hours post-procedure
Comparison of parameters related to coronary vasospasm induced by ergonovine provocation testing before and after CNA
Measured: Periprocedural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Feb 202528 Feb 2027

First posted28 May 2025
Study start7 Feb 2025
Primary completion28 Feb 2027 (estimated)
Study completion28 Feb 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Variant AnginaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06992830
Sponsor's protocol ID: 2025032
Status last verified: May 2025
First submitted: 16 May 2025
Last updated: 25 Nov 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Gangwon PCI Prospective Registry
Coronary Artery Disease, Ischemic Heart Disease (IHD)
RecruitingPhase 4
Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Variant Angina Manifesting as Aborted Sudden Cardiac Death
Angina Pectoris, Variant, Sudden Cardiac Death
Not yet recruiting
Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women
ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
Recruiting
iCorMicA - Stratified Medicine in Angina
Microvascular Angina, Angina, Stable
RecruitingObservational study
POLish Registry of CArdioneuroablation and CArdioneuromodulation
Vasovagal Syndrome VVS, Cardioinhibitory Carotid Sinus Syndrome CSS

All Variant Angina trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cardioneuroablation of Atrial Ganglionated Plexi in Patients With Variant Angina
ClinicalTrials.gov ID: NCT06992830
Acronym / sponsor ID: 2025032
Conditions: Variant Angina
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 16 participants (actual)
Lead sponsor: Zhibing LuUniversity, hospital or other
Study start: 7 Feb 2025 (actual)
Primary completion: 28 Feb 2027 (estimated)
Study completion: 28 Feb 2027 (estimated)
First posted: 28 May 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Cardioneuroablation group	Experimental	Procedure: cardioneuroablationParticipants 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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (9 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
cardioneuroablationParticipants 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 or surgery	Cardioneuroablation group

Primary outcome

Change in Frequency of Coronary Spasm Episodes
Time frame: Baseline and up to 6 months post-procedure
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.
Change in Angina Attack Frequency
Time frame: Baseline and up to 6 months after treatment
The frequency of chest pain episodes will be assessed through patient diaries and clinical interviews to evaluate symptom relief after treatment.
Severity of Coronary Spasms
Time frame: Baseline and up to 6 months post-procedure
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.
Electrocardiographic Changes
Time frame: Baseline and up to 6 months
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.
Major Adverse Cardiovascular Events
Time frame: From procedure until 6 months post-procedure
Incidence of cardiovascular events including arrhythmia, cardiac arrest, cardiac death, and acute myocardial infarction will be recorded during follow-up.
Heart Rate Variability (HRV) Changes
Time frame: Baseline and 1, 3, and 6 months post-treatment
HRV parameters will be analyzed from 24-hour Holter ECG to assess autonomic modulation following ablation.
Requirement for Anti-Anginal Medications
Time frame: Baseline and up to 6 months post-procedure
Dosage and frequency of anti-anginal drug use will be recorded to assess dependence on medication after CNA.

6 secondary outcomes

Acute Procedural Success Rate
Time frame: Intraoperative (immediate post-procedure)
Incidence of Acute Procedural Complications
Time frame: Within 24 hours post-procedure
Short-term Postoperative Complications
Time frame: Up to 30 days post-procedure
Mid- to Long-Term Complications
Time frame: From 30 days to 12 months post-procedure
Biomarker Monitoring (e.g., Cardiac Enzymes and Inflammatory Markers)
Time frame: Baseline and within 72 hours post-procedure
Comparison of parameters related to coronary vasospasm induced by ergonovine provocation testing before and after CNA
Time frame: Periprocedural

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.

Related trials for Variant Angina

RecruitingObservational study
Gangwon PCI Prospective Registry
Coronary Artery Disease, Ischemic Heart Disease (IHD)
RecruitingPhase 4
Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Variant Angina Manifesting as Aborted Sudden Cardiac Death
Angina Pectoris, Variant, Sudden Cardiac Death
Not yet recruiting
Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women
ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
Recruiting
iCorMicA - Stratified Medicine in Angina
Microvascular Angina, Angina, Stable
RecruitingObservational study
POLish Registry of CArdioneuroablation and CArdioneuromodulation
Vasovagal Syndrome VVS, Cardioinhibitory Carotid Sinus Syndrome CSS

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing cardioneuroablation in people with Variant Angina, run by Zhibing Lu at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Frequency of Coronary Spasm Episodes (time frame: Baseline and up to 6 months post-procedure). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06992830.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.