MI Related Malignant Ventricular ArrhythmiaRACAVANCT02991170
Effect of Radiofrequency Ablation in Patients With Ventricular Arrhythmia Undergoing CABG
A study testing unipolar or bipolar radiofrequency ablation+CABG and CABG in people with MI Related Malignant Ventricular Arrhythmia, run by Beijing Anzhen Hospital at 3 sites in China.
Trial summary
Patients with myocardial infarction related potential malignant ventricular arrhythmia have high risk of sudden death. The aim of this clinical trial is evaluating therapeutic efficacy of unipolar or bipolar radiofrequency ablation in Coronary Artery Bypass Grafts (CABG) Surgery, which can reduce myocardial ischemia… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- MI Related Malignant Ventricular Arrhythmia
- What is being tested?
- unipolar or bipolar radiofrequency ablation+CABG and CABG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 3 sitesChina
- Study dates
- Jan 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients have been receiving coronary artery bypass grafts from 2015.1-2017.12
- The patients had old myocardial infarction related potential malignant ventricular arrhythmia
- Anti-arrhythmic drug treatment is invalid
- All enrolled patients must being signed the informed consent
Who cannot join
- Severe heart failure( ejection fraction under 35%)
- Patients with acute myocardial infarction
- Patients with ICD implanted
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Xuanwu Hospital
Beijing, Beijing Municipality, 100000
Dong Xu, doctor, +8613910868737, lancetzkf@aliyun.com
- Recruiting
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, 100020
Ying Tian, doctor, +8613601117313, doctorty2000@163.com
- Recruiting
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
Yang Yu, doctor, +8613911524101, 13911524101@163.com
Mingxin Gao, master, +8618611979396, star880312@126.com
About this study
Official title: Impact of Radiofrequency Ablation Therapy in Coronary Artery Bypass Grafts Surgery on Outcomes in Patients With Myocardial Infarction Related Ventricular Arrhythmia
Patients with myocardial infarction related potential malignant ventricular arrhythmia have high risk of sudden death. The aim of this clinical trial is evaluating therapeutic efficacy of unipolar or bipolar radiofrequency ablation in Coronary Artery Bypass Grafts (CABG) Surgery, which can reduce myocardial ischemia and block reentry circuits of ventricular arrhythmia at the same time. The observation indexes include the morbidity of potential malignant ventricular arrhythmia and major adverse cardiovascular events in mid-long-term after CABG surgery.
- Being tested
- unipolar or bipolar radiofrequency ablation+CABG, CABG
- Keywords
- myocardial infarction, ventricular arrhythmia, radiofrequency ablation, Coronary Artery Bypass Grafts
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unipolar or bipolar radiofrequency ablation+CABGProcedure or surgery
Patients with myocardial infarction related potential malignant ventricular arrhythmia undergoing unipolar or bipolar radiofrequency ablation and Coronary Artery Bypass Grafts at the same time
CABGProcedure or surgery
Patients with myocardial infarction related potential malignant ventricular arrhythmia undergoing Coronary Artery Bypass Grafts
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Patients with myocardial infarction related potential malignant ventricular arrhythmia undergoing Coronary Artery Bypass Grafts Receives: Procedure: CABG |
| interventional group | Experimental | Patients with myocardial infarction related potential malignant ventricular arrhythmia undergoing unipolar or bipolar radiofrequency ablation and Coronary Artery Bypass Grafts at the same time Receives: Procedure: unipolar or bipolar radiofrequency ablation+CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity of potential malignant ventricular arrhythmia
The morbidity of potential malignant ventricular arrhythmia in 1 year after surgery
Measured: 1 year after surgery
Secondary outcomes (1)
Morbidity of major adverse cardiovascular events
The morbidity of the major adverse cardiovascular events in 1 year after surgery
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MI Related Malignant Ventricular ArrhythmiaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing, Beijing Chao Yang Hospital
- Responsible party
- Principal investigator, Yang Yu, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991170
- Sponsor's protocol ID
- XMLX201504
- Acronym
- RACAVA
- Status last verified
- Dec 2016
- First submitted
- 7 Dec 2016
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Radiofrequency Ablation Therapy in Coronary Artery Bypass Grafts Surgery on Outcomes in Patients With Myocardial Infarction Related Ventricular Arrhythmia
- ClinicalTrials.gov ID
- NCT02991170
- Acronym / sponsor ID
- RACAVA / XMLX201504
- Keywords
- myocardial infarction, ventricular arrhythmia, radiofrequency ablation, Coronary Artery Bypass Grafts
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing, Beijing Chao Yang Hospital
- Study start
- Jan 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 13 Dec 2016 (estimated)
- 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.
Patients with myocardial infarction related potential malignant ventricular arrhythmia have high risk of sudden death. The aim of this clinical trial is evaluating therapeutic efficacy of unipolar or bipolar radiofrequency ablation in Coronary Artery Bypass Grafts (CABG) Surgery, which can reduce myocardial ischemia and block reentry circuits of ventricular arrhythmia at the same time. The observation indexes include the morbidity of potential malignant ventricular arrhythmia and major adverse cardiovascular events in mid-long-term after CABG surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Procedure: CABGPatients with myocardial infarction related potential malignant ventricular arrhythmia undergoing Coronary Artery Bypass Grafts |
| interventional group | Experimental | Procedure: unipolar or bipolar radiofrequency ablation+CABGPatients with myocardial infarction related potential malignant ventricular arrhythmia undergoing unipolar or bipolar radiofrequency ablation and Coronary Artery Bypass Grafts at the same time |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patients have been receiving coronary artery bypass grafts from 2015.1-2017.12
- The patients had old myocardial infarction related potential malignant ventricular arrhythmia
- Anti-arrhythmic drug treatment is invalid
- All enrolled patients must being signed the informed consent
Key exclusion criteria (3 listed)
- Severe heart failure( ejection fraction under 35%)
- Patients with acute myocardial infarction
- Patients with ICD implanted
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 |
|---|---|---|
| unipolar or bipolar radiofrequency ablation+CABGPatients with myocardial infarction related potential malignant ventricular arrhythmia undergoing unipolar or bipolar radiofrequency ablation and Coronary Artery Bypass Grafts at the same time | Procedure or surgery | interventional group |
| CABGPatients with myocardial infarction related potential malignant ventricular arrhythmia undergoing Coronary Artery Bypass Grafts | Procedure or surgery | control group |
Primary outcome
Morbidity of potential malignant ventricular arrhythmia
Time frame: 1 year after surgery
The morbidity of potential malignant ventricular arrhythmia in 1 year after surgery
1 secondary outcome
Morbidity of major adverse cardiovascular events
Time frame: 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
- Individual participant dataSharing planned: Undecided
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing unipolar or bipolar radiofrequency ablation+CABG and CABG in people with MI Related Malignant Ventricular Arrhythmia, run by Beijing Anzhen Hospital at 3 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 3 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: status not confirmed, as of the sponsor's last update on 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity of potential malignant ventricular arrhythmia (time frame: 1 year after surgery). 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 13 Dec 2016.