Ventricular TachycardiaNCT06455020
Catheter Ablation of Haemodynamically Not-tolerated Electrical Storm in Structural Heart Disease
A study testing Catheter ablation and Stepped-care strategies in people with Ventricular Tachycardia, run by Beijing Anzhen Hospital at 4 sites in China.
Trial summary
This is a multi-center, parallel-group, randomized, open-label trial evaluating the clinical outcome and efficacy of emergency catheter ablation versus conventional stepped-care strategies in patients with haemodynamically not-tolerated ventricular tachycardia (VT). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- Catheter ablation and Stepped-care strategies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jul 2024to 30 Jun 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
- Patients aged 18 to 80 years;
- Having structural heart disease, including ischemic cardiomyopathy and nonischemic cardiomyopathy;
- Haemodynamically not-tolerated, defined as persistent hypotension (systolic blood pressure <90 mmHg and mean arterial pressure 30 mmHg lower than baseline or <70 mmHg, with associated signs of end-organ hypoperfusion);
- Electrical storm, defined as >3 VT episodes within 24 hours.
Who cannot join
- Reversible causes of ventricular tachycardia or cardiomyopathy;
- Ventricular thrombosis diagnosed by echocardiography and/or cardiac magnetic resonance;
- Acute ST-segment-elevation myocardial infarction within 60 days;
- Cardiac surgery within 60 days;
- Unstable angina;
- Pregnancy.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
Beijing Anzhen Hospital, Capital Medical University
Beijing
Mengmeng Li, 86+18610650190, lmm6701@163.com
Second Xiangya Hospital, Central South University
Changsha
Qiming Liu, MD, 86+13873181753, qimingliu@126.com
The Affiliated YanAn Hospital of KunMing Medical University
Kunming
Shaolong Li, MD, 86+13700651472, 13700651472@126.com
The First Affiliated Hospital of Nanjing Medical University
Nanjing
Jiangang Zou, MD, 86+13605191407, jgzou@njmu.edu.cn
About this study
This is a multi-center, parallel-group, randomized, open-label trial evaluating the clinical outcome and efficacy of emergency catheter ablation versus conventional stepped-care strategies in patients with haemodynamically not-tolerated ventricular tachycardia (VT).
Read the detailed description
The prognosis of haemodynamically not-tolerated VT in structural heart disease is very poor, with a high 30-day mortality rate >30%, resulting in extremely heavy medical burden. Current guidelines lack specific recommendations for managing this condition. The prevailing treatment strategy involves a sequential approach-beginning with anti-arrhythmic drugs, sedation, and anesthesia, followed by haemodynamic mechanical support devices. Catheter ablation is only used as the final rescue treatment. Typically, patients undergo repeated electrical cardioversion and receive multiple vasopressors and antiarrhythmic drugs, facing increased risks of complications from enhanced haemodynamic support. Studies have shown that these patients often eventually progress to irreversible pump failure, miss the window for effective catheter ablation, and ultimately die. Early cardioversion and maintenance of sinus rhythm, may significantly reduce mortality rates in patients with haemodynamically not-tolerated VT. Therefore, emergency catheter ablation is expected to reduce the mortality of haemodynamically not-tolerated ventricular tachycardia.
In this study, we aim to evaluate the effect of emergency catheter ablation in haemodynamically not-tolerated ventricular tachycardia. Current study will include 96 patients, and all patients will be randomized to either the emergency catheter ablation arm or stepped-care strategies arm in a 1:1 fashion. The follow-up duration is 1 year. The primary outcome is a composite outcome of VT recurrence, cardiovascular re-hospitalization, and all-cause mortality.
- Conditions
- Ventricular Tachycardia
- Being tested
- Catheter ablation, Stepped-care strategies
- Keywords
- Catheter ablation, Mortality, Electrical storm
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablationProcedure or surgery
Emergency catheter ablation is defined as ablation performed within 48 hours of hospital admission
Stepped-care strategiesProcedure or surgery
Patients randomized to the stepped-care strategy arm will receive treatment through a systematic, stepwise protocol beginning with anti-arrhythmic drugs, followed by sedation and anesthesia, and progressing to haemodynamic mechanical support devices if earlier treatments prove ineffective. Catheter ablation will be reserved as the final rescue intervention.
| Study group | Role | What they receive |
|---|---|---|
| Catheter ablation | Experimental | Patients randomized to the emergency catheter ablation arm will first undergo catheter ablation. Vasopressors, antiarrhythmic drugs, and hemodynamic mechanical support devices will be adopted as needed. All patients will be advised for ICD implantation before discharge. Receives: Procedure: Catheter ablation |
| Stepped-care strategies | Active comparator | Patients randomized to the stepped-care strategies arm will undergo a stepwise progressive procedure, with anti-arrhythmic drugs, sedation and anesthesia, and hemodynamic mechanical support devices, that is, the next treatment is only started when the previous sequence of treatment is ineffective, and catheter ablation is only used as the final rescue treatment. All patients will be advised for ICD implantation before discharge. Receives: Procedure: Stepped-care strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcomes of ventricular tachycardia recurrence, cardiovascular hospitalization, or death during the 30-day follow-up
Recurrent ventricular tachycardia is defined as any appropriate implantable cardiac defibrillation therapy (shock or antitachycardia pacing) or documented sustained monomorphic ventricular tachycardia >30 seconds. Cardiovascular rehospitalization is defined as a hospital admission after the randomly assigned procedure for heart failure, procedure-associated complications, or arrhythmic causes during the 30-day follow-up.
Measured: 30 days
Secondary outcomes (5)
Recurrence of ventricular tachycardia during the 30-day follow-up
Recurrent ventricular tachycardia is defined as any appropriate implantable cardiac defibrillation therapy (shock or antitachycardia pacing) or documented sustained monomorphic ventricular tachycardia >30 seconds during the 30-day follow-up.
Measured: 30 days
Cardiovascular re-hospitalization during the 30-day follow-up
Cardiovascular re-hospitalization is defined as a hospital admission after the randomly assigned procedure for heart failure, procedure-associated complications, or arrhythmic causes during the 30-day follow-up.
Measured: 30 days
All-cause mortality during the 30-day follow-up
All-cause mortality is defined as the death from all causes during the 30-day follow-up.
Measured: 30 days
Composite outcomes of ventricular tachycardia recurrence, cardiovascular hospitalization, or death during the 1-year follow-up
Recurrent ventricular tachycardia is defined as any appropriate implantable cardiac defibrillation therapy (shock or antitachycardia pacing) or documented sustained monomorphic ventricular tachycardia >30 seconds. Cardiovascular rehospitalization is defined as a hospital admission after the randomly assigned procedure for heart failure, procedure-associated complications, or arrhythmic causes during the 1-year follow-up.
Measured: 1 year
All-cause mortality during the 1-year follow-up
All-cause mortality is defined as the death from all causes during the 1-year follow-up.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deyong Long, MD, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455020
- Sponsor's protocol ID
- 2024-vtstorm
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter Ablation of Haemodynamically Not-tolerated Electrical Storm in Structural Heart Disease
- ClinicalTrials.gov ID
- NCT06455020
- Acronym / sponsor ID
- 2024-vtstorm
- Conditions
- Ventricular Tachycardia
- Keywords
- Catheter ablation, Mortality, Electrical storm
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 12 Jun 2024 (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.
This is a multi-center, parallel-group, randomized, open-label trial evaluating the clinical outcome and efficacy of emergency catheter ablation versus conventional stepped-care strategies in patients with haemodynamically not-tolerated ventricular tachycardia (VT).
Detailed description
The prognosis of haemodynamically not-tolerated VT in structural heart disease is very poor, with a high 30-day mortality rate >30%, resulting in extremely heavy medical burden. Current guidelines lack specific recommendations for managing this condition. The prevailing treatment strategy involves a sequential approach-beginning with anti-arrhythmic drugs, sedation, and anesthesia, followed by haemodynamic mechanical support devices. Catheter ablation is only used as the final rescue treatment. Typically, patients undergo repeated electrical cardioversion and receive multiple vasopressors and antiarrhythmic drugs, facing increased risks of complications from enhanced haemodynamic support. Studies have shown that these patients often eventually progress to irreversible pump failure, miss the window for effective catheter ablation, and ultimately die. Early cardioversion and maintenance of sinus rhythm, may significantly reduce mortality rates in patients with haemodynamically not-tolerated VT. Therefore, emergency catheter ablation is expected to reduce the mortality of haemodynamically not-tolerated ventricular tachycardia.
In this study, we aim to evaluate the effect of emergency catheter ablation in haemodynamically not-tolerated ventricular tachycardia. Current study will include 96 patients, and all patients will be randomized to either the emergency catheter ablation arm or stepped-care strategies arm in a 1:1 fashion. The follow-up duration is 1 year. The primary outcome is a composite outcome of VT recurrence, cardiovascular re-hospitalization, and all-cause mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter ablation | Experimental | Procedure: Catheter ablationPatients randomized to the emergency catheter ablation arm will first undergo catheter ablation. Vasopressors, antiarrhythmic drugs, and hemodynamic mechanical support devices will be adopted as needed. All patients will be advised for ICD implantation before discharge. |
| Stepped-care strategies | Active comparator | Procedure: Stepped-care strategiesPatients randomized to the stepped-care strategies arm will undergo a stepwise progressive procedure, with anti-arrhythmic drugs, sedation and anesthesia, and hemodynamic mechanical support devices, that is, the next treatment is only started when the previous sequence of treatment is ineffective, and catheter ablation is only used as the final rescue treatment. All patients will be advised for ICD implantation before discharge. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 to 80 years;
- Having structural heart disease, including ischemic cardiomyopathy and nonischemic cardiomyopathy;
- Haemodynamically not-tolerated, defined as persistent hypotension (systolic blood pressure <90 mmHg and mean arterial pressure 30 mmHg lower than baseline or <70 mmHg, with associated signs of end-organ hypoperfusion);
- Electrical storm, defined as >3 VT episodes within 24 hours.
Key exclusion criteria (6 listed)
- Reversible causes of ventricular tachycardia or cardiomyopathy;
- Ventricular thrombosis diagnosed by echocardiography and/or cardiac magnetic resonance;
- Acute ST-segment-elevation myocardial infarction within 60 days;
- Cardiac surgery within 60 days;
- Unstable angina;
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 |
|---|---|---|
| Catheter ablationEmergency catheter ablation is defined as ablation performed within 48 hours of hospital admission | Procedure or surgery | Catheter ablation |
| Stepped-care strategiesPatients randomized to the stepped-care strategy arm will receive treatment through a systematic, stepwise protocol beginning with anti-arrhythmic drugs, followed by sedation and anesthesia, and progressing to haemodynamic mechanical support devices if earlier treatments prove ineffective. Catheter ablation will be reserved as the final rescue intervention. | Procedure or surgery | Stepped-care strategies |
Primary outcome
Composite outcomes of ventricular tachycardia recurrence, cardiovascular hospitalization, or death during the 30-day follow-up
Time frame: 30 days
Recurrent ventricular tachycardia is defined as any appropriate implantable cardiac defibrillation therapy (shock or antitachycardia pacing) or documented sustained monomorphic ventricular tachycardia >30 seconds. Cardiovascular rehospitalization is defined as a hospital admission after the randomly assigned procedure for heart failure, procedure-associated complications, or arrhythmic causes during the 30-day follow-up.
5 secondary outcomes
Recurrence of ventricular tachycardia during the 30-day follow-up
Time frame: 30 days
Cardiovascular re-hospitalization during the 30-day follow-up
Time frame: 30 days
All-cause mortality during the 30-day follow-up
Time frame: 30 days
Composite outcomes of ventricular tachycardia recurrence, cardiovascular hospitalization, or death during the 1-year follow-up
Time frame: 1 year
All-cause mortality during the 1-year follow-up
Time frame: 1 year
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 12 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Ventricular Tachycardia
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
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.
Deyong Long, MD principal investigator
Beijing Anzhen Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter ablation and Stepped-care strategies in people with Ventricular Tachycardia, run by Beijing Anzhen Hospital at 4 sites 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 6 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: opening soon, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Contact Deyong Long, MD (+86 (010) 84005361, dragon2008@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcomes of ventricular tachycardia recurrence, cardiovascular hospitalization, or death during the 30-day follow-up (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2024.