Premature Ventricular ComplexNCT03249545
Late Effect of Ablation on Premature Ventricular Complex Ablation
An observational study of Premature Ventricular Complex and Electrophysiology, run by Yuksek Ihtisas Hospital at 1 site in Turkey (Türkiye).
Trial summary
Premature Ventricular Complex (PVC) ablation is performed in certain indications. Generally acutely abolition of PVC at the time of ablation accepted as successful ablation. However in some patients this effect occurs lately. In this study investigators sought late effect of ablation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Premature Ventricular Complex, Electrophysiology, Ablation
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2017to 1 Mar 2019
- 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: Individuals having premature complexes and matching ablation indications are included and selection will be based on above mentioned criteria
Who may be able to join
- Patients who had both of the criteria below
- Presence of premature ventricular complex requiring ablation
- Successfully abolition of premature ventricular complex hours after the procedure
Who cannot join
- Patients who had either of below mentioned criteria
- Abolition of premature ventricular complex during the procedure
- Unsuccessful procedure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Turkiye Yuksek Ihtisas Training and Research Hospital
Ankara, 06590
Firat R Ozcan, Ass. Prof, MD, 5327854000, drfozcan@gmail.com
About this study
Premature Ventricular Complex (PVC) ablation is performed in certain indications. Generally acutely abolition of PVC at the time of ablation accepted as successful ablation. However in some patients this effect occurs lately. In this study investigators sought late effect of ablation
Read the detailed description
On tissue level ablation lesion deepens and enlarges by time following the procedure. Based on this, investigators aimed to seek patients who has no acute success but late success. This phenomenon occurs in some patients. Investigators investigate the characteristics of those patients on both procedural and clinical aspects. Investigators enroll patients applied during prespecified dates
- Conditions
- Premature Ventricular Complex, Electrophysiology, Ablation
- Medical subject headings
- Ventricular Premature Complexes
What is being measured
The primary outcome is the main question the study is designed to answer.
Success
Continuation of ablation on the long term
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start1 Jul 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ventricular ComplexStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuksek Ihtisas Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fırat Özcan, Yuksek Ihtisas Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249545
- Sponsor's protocol ID
- ozcan02
- Status last verified
- Aug 2017
- First submitted
- 6 Aug 2017
- Last updated
- 15 Aug 2017
- 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 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late Effect of Ablation on Premature Ventricular Complex Ablation
- ClinicalTrials.gov ID
- NCT03249545
- Acronym / sponsor ID
- ozcan02
- Conditions
- Premature Ventricular Complex, Electrophysiology, Ablation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yuksek Ihtisas HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 15 Aug 2017 (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.
Premature Ventricular Complex (PVC) ablation is performed in certain indications. Generally acutely abolition of PVC at the time of ablation accepted as successful ablation. However in some patients this effect occurs lately. In this study investigators sought late effect of ablation
Detailed description
On tissue level ablation lesion deepens and enlarges by time following the procedure. Based on this, investigators aimed to seek patients who has no acute success but late success. This phenomenon occurs in some patients. Investigators investigate the characteristics of those patients on both procedural and clinical aspects. Investigators enroll patients applied during prespecified dates
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
- Individuals having premature complexes and matching ablation indications are included and selection will be based on above mentioned criteria
Key inclusion criteria (3 listed)
- Patients who had both of the criteria below
- Presence of premature ventricular complex requiring ablation
- Successfully abolition of premature ventricular complex hours after the procedure
Key exclusion criteria (3 listed)
- Patients who had either of below mentioned criteria
- Abolition of premature ventricular complex during the procedure
- Unsuccessful procedure
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
Success
Time frame: 3 months
Continuation of ablation on the long term
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2017.
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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.
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 Premature Ventricular Complex and Electrophysiology, run by Yuksek Ihtisas Hospital at 1 site in Turkey (Türkiye).
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: status not confirmed, as of the sponsor's last update on 15 Aug 2017. 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 Turkey (Türkiye). 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?
Contact Firat Ozcan, Ass. Prof, MD (+905327854000, drfozcan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success (time frame: 3 months). 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 15 Aug 2017.