Ventricular TachycardiaNCT04837183
Catheter Ablation of Ventricular Arrhythmia Reduces Skin Sympathetic Activity
An observational study of Ventricular Tachycardia, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being done to determine whether there is an increase in sympathetic nerve activity before the onset of ventricular arrhythmias or irregular heartbeat rhythm. In addition, this study is looking at the relationship between sympathetic nerve activity and how patients with ventricular arrhythmias respond to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2021to 1 Jan 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients will undergo catheter ablation to control VA recommended by current guideline.
Who may be able to join
- Patients who have non-sustained or sustained VA (VA ≥ 30s or receiving appropriate ICD therapies) are presented to the clinic or admitted to the hospital within 7 days of episodes.
- The causes of VA are associated with structural heart diseases including ischemic or nonischemic cardiomyopathy (idiopathic cardiomyopathy, hypertrophic cardiomyopathy, cardiac sarcoidosis or amyloidosis, and arrhythmogentic right ventricular dysplasia).
- Subjects are 18 years of age and older.
Who cannot join
- Female patients who is pregnant or of childbearing potential and not on a reliable form of birth control.
- Allergic to skin patch electrodes.
- Vulnerable populations (fetuses, neonates, pregnant women, prisoners, institutionalized individuals).
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
This study is being done to determine whether there is an increase in sympathetic nerve activity before the onset of ventricular arrhythmias or irregular heartbeat rhythm. In addition, this study is looking at the relationship between sympathetic nerve activity and how patients with ventricular arrhythmias respond to catheter ablation treatment.
- Conditions
- Ventricular Tachycardia
- Medical subject headings
- Tachycardia, Ventricular
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in amplitude of skin sympathetic nerve activity
measured in µV
Measured: Baseline, 24 hours post catheter ablation and approximately 3-6 months post-operative
Change in LF/HF ratio
low frequency (LF)/high frequency (HF) ratio of the skin sympathetic nerve activity
Measured: Baseline, 24 hours post catheter ablation and approximately 3-6 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start15 Nov 2021
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Why it stopped: This study was closed before its planned primary completion date because early data indicated that VT ablation had little impact on sympathetic nerve activity in short-term follow up.
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 Mayo ClinicThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Cedars-Sinai Medical Center
- Responsible party
- Principal investigator, Yong-Mei Cha, Mayo Clinic
- Investigators
- Yong-Mei Cha, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837183
- Sponsor's protocol ID
- 20-001448
- Status last verified
- Jun 2024
- First submitted
- 16 Mar 2021
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter Ablation of Ventricular Arrhythmia Reduces Skin Sympathetic Activity
- ClinicalTrials.gov ID
- NCT04837183
- Acronym / sponsor ID
- 20-001448
- Conditions
- Ventricular Tachycardia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This study was closed before its planned primary completion date because early data indicated that VT ablation had little impact on sympathetic nerve activity in short-term follow up.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Cedars-Sinai Medical Center
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 8 Apr 2021 (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 study is being done to determine whether there is an increase in sympathetic nerve activity before the onset of ventricular arrhythmias or irregular heartbeat rhythm. In addition, this study is looking at the relationship between sympathetic nerve activity and how patients with ventricular arrhythmias respond to catheter ablation treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients will undergo catheter ablation to control VA recommended by current guideline.
Key inclusion criteria (3 listed)
- Patients who have non-sustained or sustained VA (VA ≥ 30s or receiving appropriate ICD therapies) are presented to the clinic or admitted to the hospital within 7 days of episodes.
- The causes of VA are associated with structural heart diseases including ischemic or nonischemic cardiomyopathy (idiopathic cardiomyopathy, hypertrophic cardiomyopathy, cardiac sarcoidosis or amyloidosis, and arrhythmogentic right ventricular dysplasia).
- Subjects are 18 years of age and older.
Key exclusion criteria (3 listed)
- Female patients who is pregnant or of childbearing potential and not on a reliable form of birth control.
- Allergic to skin patch electrodes.
- Vulnerable populations (fetuses, neonates, pregnant women, prisoners, institutionalized individuals).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in amplitude of skin sympathetic nerve activity
Time frame: Baseline, 24 hours post catheter ablation and approximately 3-6 months post-operative
measured in µV
Change in LF/HF ratio
Time frame: Baseline, 24 hours post catheter ablation and approximately 3-6 months post-operative
low frequency (LF)/high frequency (HF) ratio of the skin sympathetic nerve activity
Results and safety
The study was stopped early (reason given: This study was closed before its planned primary completion date because early data indicated that VT ablation had little impact on sympathetic nerve activity in short-term follow up.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Ventricular Tachycardia
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Assessment of Combined CCM and ICD Device in HFrEF
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A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
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Genetic Markers of Cardiovascular Disease in Epilepsy
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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. This study is not recruiting at the moment.
Yong-Mei Cha, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia, run by Mayo Clinic at 1 site in United States.
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 3 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: stopped early, as of the sponsor's last update on 3 Jul 2024. 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 United States. 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?
The study was stopped early (reason given: This study was closed before its planned primary completion date because early data indicated that VT ablation had little impact on sympathetic nerve activity in short-term follow up.). Results are not available in the source record.
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 amplitude of skin sympathetic nerve activity (time frame: Baseline, 24 hours post catheter ablation and approximately 3-6 months post-operative). The study lists 2 primary outcomes in all. 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 3 Jul 2024.