High-quality Pulmonary Veins Isolation Using Varipulse Catheter Under Contact and Continuity Guidance in Patients With Paroxysmal Atrial Fibrillation Under Optimized Sedation
New study tests Varipulse catheter for irregular heartbeat with optimized sedation
Plain English Summary
A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation is a Not Applicable clinical trial sponsored by Johnson & Johnson Medical (Shanghai) Ltd. studying Atrial Fibrillation. This study tests the Varipulse catheter, a standard treatment for atrial fibrillation, using different sedation methods. It is for adults with symptomatic paroxysmal atrial fibrillation that hasn't responded to medication. Participants will undergo a catheter ablation procedure and follow-up visits. Alternatives include medication, other ablation techniques, or lifestyle changes. The trial aims to enroll 300 participants.
Official Summary
The main purpose of the study is to assess how well the standard ablation procedure (Varipulse Catheter) works over long term when used with different types of anesthesia in participants with symptomatic paroxysmal atrial fibrillation (PAF, irregular heartbeat that comes and goes on its own, causing noticeable symptoms like a racing heart, or shortness of breath).
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18-80 with a specific type of irregular heartbeat (paroxysmal atrial fibrillation) that is symptomatic and hasn't improved with certain medications. Individuals must be able to follow study instructions and give consent. Cannot join if the irregular heartbeat is caused by other conditions, if they've had previous heart procedures, or have certain heart size or function issues. Women who are pregnant, breastfeeding, or planning to become pregnant, and those with a life expectancy under 12 months are excluded. This trial is studying Atrial Fibrillation, so participants generally need a confirmed diagnosis.
What They're Measuring
The main goal is to see if patients remain free from symptomatic or silent episodes of irregular heartbeat for a full year after the procedure, indicating the treatment's lasting success. The specific primary outcome measures are: Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias Episode (Day 91 to Day 365 post index procedure). 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 aims to improve the long-term effectiveness of a common procedure for atrial fibrillation by optimizing sedation, addressing a need for more predictable and comfortable treatment outcomes. This research targets Atrial Fibrillation, where improved treatment options are needed.
Investor Insight
This observational study by Johnson & Johnson Medical focuses on optimizing a known treatment for a common condition, suggesting a commitment to refining existing therapies rather than developing new
Is This Trial Right for Me?
Ask your doctor about the specific sedation methods used and what to expect during and after the procedure. Participation involves a catheter ablation procedure and regular follow-up appointments for a year. Be prepared for potential discomfort and the need to adhere strictly to post-procedure care instructions. The trial is being conducted at multiple sites. 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: 300 participants
Primary Outcomes
- Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias Episode (Day 91 to Day 365 post index procedure)
Secondary Outcomes
- Acute Procedural Success (Intraoperative)
- Acute Reconnection (Intraoperative)
- Repeat Ablation (Up to 12 months post-index procedure)
- PV Re-Connection (Up to 12 months post-index procedure)
- Pain Visual Analogue Scale (VAS) Score (Prior to Discharge (up to Day 1 post-index procedure))
Full Eligibility Criteria
Inclusion criteria: * Diagnosed with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF) or intolerable to class I and/or III antiarrhythmic drugs (AAD) based on medical records * Age 18-80 years * Able and willing to comply with all pre-procedure, post-procedure, and follow-up testing and visit requirements * Signed patient informed consent form (ICF) Exclusion criteria: * Atrial fibrillation (AF) secondary to electrolyte imbalance, hyperthyroidism, or reversible or non-cardiac cause * Previous left atrium (LA) ablation or surgery * Left atrium diameter (LAD) greater than (\>) 50 millimeters (mm) by transthoracic echocardiography (TTE) * Left ventricular ejection fraction (LVEF) less than (\<) 40 percent (%) * Known significant pulmonary vein (PV) anomaly that in the opinion of the investigator would preclude enrollment in this study * Current enrollment in an investigational study evaluating another device or drug * Women who are pregnant (as evidenced by pregnancy test or oral confirmation if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation * Life expectancy less than 12 months * Presenting contra-indications for the devices used in the study, as indicated in the respective instructions for use (IFU) * Presenting contra-indications for catheter ablation at physicians' discretion, for example LA/Left atrial appendage (LAA) thrombus, systematic infection, situations preventing catheter access * Other conditions that, at discretion of the investigators, would preclude enrollment in this study
Frequently Asked Questions
What is clinical trial NCT07511166?
NCT07511166 is a Not Applicable OBSERVATIONAL study titled "A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation." It is currently not yet recruiting and is sponsored by Johnson & Johnson Medical (Shanghai) Ltd.. The trial targets enrollment of 300 participants.
What conditions does NCT07511166 study?
This trial investigates treatments for Atrial Fibrillation. The primary condition under study is Atrial Fibrillation.
What does Not Applicable mean for NCT07511166?
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 NCT07511166?
This trial is currently "Not Yet Recruiting." It started on 2026-03-31. The estimated completion date is 2028-02-09.
Who is sponsoring NCT07511166?
NCT07511166 is sponsored by Johnson & Johnson Medical (Shanghai) Ltd.. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07511166?
The trial aims to enroll 300 participants. The trial has not yet started recruiting.
How is NCT07511166 designed?
This is a observational study.
What are the primary outcomes being measured in NCT07511166?
The primary outcome measures are: Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias Episode (Day 91 to Day 365 post index procedure). These are the main endpoints researchers use to determine whether the treatment is effective.
Where can I find official information about NCT07511166?
The official record for NCT07511166 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07511166. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07511166 testing in simple terms?
This study tests the Varipulse catheter, a standard treatment for atrial fibrillation, using different sedation methods. It is for adults with symptomatic paroxysmal atrial fibrillation that hasn't responded to medication.
Why is this trial significant?
This trial aims to improve the long-term effectiveness of a common procedure for atrial fibrillation by optimizing sedation, addressing a need for more predictable and comfortable treatment outcomes.
What are the potential risks of participating in NCT07511166?
The main risks are related to the ablation procedure itself, such as bleeding, infection, or damage to blood vessels. Potential side effects include pain, bruising at the insertion site, and temporary discomfort. There's a small risk of the irregular heartbeat returning or complications like stroke or heart attack. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07511166?
Ask your doctor about the specific sedation methods used and what to expect during and after the procedure. Participation involves a catheter ablation procedure and regular follow-up appointments for a year. Be prepared for potential discomfort and the need to adhere strictly to post-procedure care instructions. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07511166 signal from an investment perspective?
This observational study by Johnson & Johnson Medical focuses on optimizing a known treatment for a common condition, suggesting a commitment to refining existing therapies rather than developing new This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will undergo a catheter ablation procedure and follow-up visits. 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.
Related Conditions
More Atrial Fibrillation Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.