Ventricular Outflow Tract TachycardiaNCT02722577
EGM Analysis in Idiopathic Outflow Tract Ventricular Arrhythmia
An observational study of Ventricular Outflow Tract Tachycardia, run by Abbott Medical Devices.
Trial summary
Investigate the value of unipolar and bipolar electrograms (EGM) for predicting the successful ablation site for idiopathic outflow tract ventricular arrhythmia (OTVA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Outflow Tract Tachycardia
- What is being tested?
- Radio-frequency Ablation
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to May 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: 20 patients meeting the inclusion and exclusion criteria
Who may be able to join
- Patients scheduled to undergo ablation for idiopathic OTVA
- Have the ability to provide informed consent for study participation.
Who cannot join
- Be currently participating in any other investigational study
- Be less than 18 years of age
- Be pregnant
- Has any other conditions that are not suitable for catheter ablation (including but are not limited to active whole-body infection or sepsis, coagulation or hemorrhage disorder history)
About this study
Official title: Usefulness of Unipolar and Bipolar Electrograms in Predicting Successful Ablation Site During Idiopathic Outflow Tract Ventricular Arrhythmia Ablation
Investigate the value of unipolar and bipolar electrograms (EGM) for predicting the successful ablation site for idiopathic outflow tract ventricular arrhythmia (OTVA).
Read the detailed description
The proposed study aims to evaluate the predictive value of using reversed polarity in adjacent bipolar EGMs (bi-RP method) and unipolar EGM with QS morphology (uni-QS method) for identifying successful ablation site, and evaluate the feasibility of enhancing uni-QS method's performance by using its morphology characteristics such as descending slope and symmetry.
- Conditions
- Ventricular Outflow Tract Tachycardia
- Being tested
- Radio-frequency Ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radio-frequency AblationProcedure or surgery
A procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Ablation Targets With Termination of the Clinical Ventricular Arrhythmia After RF Energy Delivery
Measured: Intraoperative, an average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ventricular Outflow Tract TachycardiaStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guodong Niu, MD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722577
- Sponsor's protocol ID
- SJM-CIP-10090
- Status last verified
- Jul 2019
- First submitted
- 8 Mar 2016
- Last updated
- 6 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Unipolar and Bipolar Electrograms in Predicting Successful Ablation Site During Idiopathic Outflow Tract Ventricular Arrhythmia Ablation
- ClinicalTrials.gov ID
- NCT02722577
- Acronym / sponsor ID
- SJM-CIP-10090
- Conditions
- Ventricular Outflow Tract Tachycardia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Mar 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Posted 29 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigate the value of unipolar and bipolar electrograms (EGM) for predicting the successful ablation site for idiopathic outflow tract ventricular arrhythmia (OTVA).
Detailed description
The proposed study aims to evaluate the predictive value of using reversed polarity in adjacent bipolar EGMs (bi-RP method) and unipolar EGM with QS morphology (uni-QS method) for identifying successful ablation site, and evaluate the feasibility of enhancing uni-QS method's performance by using its morphology characteristics such as descending slope and symmetry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 20 patients meeting the inclusion and exclusion criteria
Key inclusion criteria (2 listed)
- Patients scheduled to undergo ablation for idiopathic OTVA
- Have the ability to provide informed consent for study participation.
Key exclusion criteria (4 listed)
- Be currently participating in any other investigational study
- Be less than 18 years of age
- Be pregnant
- Has any other conditions that are not suitable for catheter ablation (including but are not limited to active whole-body infection or sepsis, coagulation or hemorrhage disorder history)
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 |
|---|---|---|
| Radio-frequency AblationA procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats. | Procedure or surgery | – |
Primary outcome
Percent of Ablation Targets With Termination of the Clinical Ventricular Arrhythmia After RF Energy Delivery
Time frame: Intraoperative, an average of 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Ventricular Outflow Tract Tachycardia
RecruitingObservational study
Mayo AVC Registry and Biobank
Arrhythmogenic Right Ventricular Cardiomyopathy, Cardiomyopathies
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.
Guodong Niu, MD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Outflow Tract Tachycardia, run by Abbott Medical Devices.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 29 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent of Ablation Targets With Termination of the Clinical Ventricular Arrhythmia After RF Energy Delivery (time frame: Intraoperative, an average of 2 hours). 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 6 Aug 2019.