PROSPective Evaluation of Outcome After CatheTer Ablation in Atrial Fibrillation : LONGITUDINAL STUDY OF PATIENTS UNDERGOING RADIOFREQUENCY ABLATION OF ATRIAL FIBRILLATION.
Study tracks outcomes after heart rhythm ablation for atrial fibrillation
Plain English Summary
PROSPective Evaluation of Outcome After CatheTer Ablation in Atrial Fibrillation is a Not Applicable clinical trial sponsored by University Hospital, Lille studying Atrial Fibrillation. This study observes patients who have undergone a procedure to correct atrial fibrillation (AF), a common heart rhythm disorder. It is for adults with atrial fibrillation who are having or have had a catheter ablation to treat their condition. Participation involves regular check-ups and data collection for up to 3 years after the ablation procedure. Alternatives to ablation include medication to control heart rate or rhythm, or lifestyle changes. The trial aims to enroll 750 participants.
Official Summary
Atrial fibrillation ablation is the most common intervention performed worldwide. Up to 20 to 45% of patients show recurrence of AF within 12 month after catheter ablation, however its determinant are incompletely understood. The aim of the PROSPECT-AF study is to assess the predictors of AF recurrence within the 3 years following ablation using clinical variables and innovative biomarkers in a prospective cohort of 750 patients undergoing atrial fibrillation catheter ablation. The secondary aims are to assess the incidence of major adverse cardiovascular outcomes (MACE) and the incidence of major bleeding within the 3 years Wolfing catheter ablation.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults undergoing catheter ablation for atrial fibrillation can join. Patients must be able to give their consent to participate. Children, patients under guardianship, or those unable to consent cannot join. Pregnant individuals are also excluded. This trial is studying Atrial Fibrillation, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how often atrial fibrillation comes back within 3 years after the ablation, giving patients an idea of the long-term effectiveness of the procedure. The specific primary outcome measures are: Incidence of atrial fibrillation recurrence. (At 3 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because it aims to understand why some patients experience a return of atrial fibrillation after ablation, helping to improve treatment success rates. This research targets Atrial Fibrillation, where improved treatment options are needed.
Investor Insight
This observational study focuses on a common procedure, suggesting a significant market for AF treatments and a need for better prediction of recurrence, which could inform future device or therapy de The large enrollment target of 750 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor about the risks and benefits of catheter ablation compared to other treatments. Understand how often you will need to visit the clinic and what tests will be performed. Be prepared for follow-up appointments and potential data collection over the next 3 years. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 750 participants
Interventions
- PROCEDURE: atrial fibrillation catheter ablation — The ablation is performed under local anesthesia or general anesthesia. A transseptal puncture will be performed to access the left atrium. Pulmonary vein isolation will be performed as a first step. Additional lesions will be made at the discretion of the operators. Patients will receive anticoagulation for at least 3 months after the ablation. Treatment thereafter will be extended at the discretion of the treating physician.
Primary Outcomes
- Incidence of atrial fibrillation recurrence. (At 3 years)
Secondary Outcomes
- Incidence of major adverse cardiovascular events (MACE) including hospitalization for acute heart failure, cardiovascular death, stroke, myocardial infarction (At 3 years)
- Incidence of major bleeding (defined by BARC≥3 bleeding) (At 3 years)
Full Eligibility Criteria
Inclusion Criteria: * Patient undergoing atrial fibrillation catheter ablation * Able to give their consent Exclusion Criteria: * Childs * Patient under guardianship * Patients unable to give their consent * Pregnancy
Trial Locations
- Institut Coeur-Poumon, CHU, Lille, France
Frequently Asked Questions
What is clinical trial NCT05009797?
NCT05009797 is a Not Applicable OBSERVATIONAL study titled "PROSPective Evaluation of Outcome After CatheTer Ablation in Atrial Fibrillation." It is currently recruiting and is sponsored by University Hospital, Lille. The trial targets enrollment of 750 participants.
What conditions does NCT05009797 study?
This trial investigates treatments for Atrial Fibrillation. The primary condition under study is Atrial Fibrillation.
What treatments are being tested in NCT05009797?
The interventions being studied include: atrial fibrillation catheter ablation (PROCEDURE). The ablation is performed under local anesthesia or general anesthesia. A transseptal puncture will be performed to access the left atrium. Pulmonary vein isolation will be performed as a first step. Additional lesions will be made at the discretion of the operators. Patients will receive anticoagulation for at least 3 months after the ablation. Treatment thereafter will be extended at the discretion of the treating physician.
What does Not Applicable mean for NCT05009797?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT05009797?
This trial is currently "Recruiting." It started on 2023-02-16. The estimated completion date is 2031-02.
Who is sponsoring NCT05009797?
NCT05009797 is sponsored by University Hospital, Lille. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05009797?
The trial aims to enroll 750 participants. The trial is currently recruiting and accepting new participants.
How is NCT05009797 designed?
This is a observational study.
What are the primary outcomes being measured in NCT05009797?
The primary outcome measures are: Incidence of atrial fibrillation recurrence. (At 3 years). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05009797 being conducted?
This trial is being conducted at 1 site, including Lille (France).
Where can I find official information about NCT05009797?
The official record for NCT05009797 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05009797. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05009797 testing in simple terms?
This study observes patients who have undergone a procedure to correct atrial fibrillation (AF), a common heart rhythm disorder. It is for adults with atrial fibrillation who are having or have had a catheter ablation to treat their condition.
Why is this trial significant?
This trial is important because it aims to understand why some patients experience a return of atrial fibrillation after ablation, helping to improve treatment success rates.
What are the potential risks of participating in NCT05009797?
The main risk is the recurrence of atrial fibrillation, meaning the irregular heartbeat may return. Potential side effects of the ablation procedure itself include bleeding, infection, or damage to blood vessels. There is also a risk of major adverse cardiovascular events like stroke or heart failure, and major bleeding. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05009797?
Ask your doctor about the risks and benefits of catheter ablation compared to other treatments. Understand how often you will need to visit the clinic and what tests will be performed. Be prepared for follow-up appointments and potential data collection over the next 3 years. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05009797 signal from an investment perspective?
This observational study focuses on a common procedure, suggesting a significant market for AF treatments and a need for better prediction of recurrence, which could inform future device or therapy de This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves regular check-ups and data collection for up to 3 years after the ablation procedure. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.