Trial studying safety and effects for Atrial Fibrillation
Official title A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System
ClinicalTrials.gov ID: NCT07227532
What this study is testing
- What it's testing
- The study aims to find out how safe and how well the FDA‑approved VARIPULSE catheter works over the long term for pulmonary vein isolation in symptomatic paroxysmal atrial fibrillation.
- Who it's for
- Adults who have symptomatic paroxysmal atrial fibrillation.
- What's involved
- Participants will have the VARIPULSE catheter procedure to isolate the pulmonary veins, followed by scheduled check‑ups and tests to monitor safety and heart rhythm.
- Time commitment
- The study follows participants for several years with periodic clinic visits and assessments.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- Symptomatic paroxysmal Atrial Fibrillation (AF) who, in the opinion of the investigator, are candidates for catheter ablation for AF
- Refractory (that is, ineffective, not tolerated, or not desired) or contraindicated to at least one Class I/III antiarrhythmic drugs (AAD)
- Willing and capable of providing consent
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements
You likely can't join if
- Previously diagnosed with persistent or long-standing persistent AF (more than [\>] 7 days in duration)
- Previous surgical or catheter ablation for AF
- Significant congenital anomaly or medical problem that in the opinion of the investigator would be a contraindication to catheter ablation for AF
- Current enrollment in an investigational study evaluating another device or drug
- Life expectancy less than 12 months
- Any contraindications as defined in the Protocol
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Fountain Valley, California, United States
- Ventura, California, United States
- Aurora, Colorado, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Naperville, Illinois, United States
- Iowa City, Iowa, United States
- Kansas City, Kansas, United States
- Overland Park, Kansas, United States
- Detroit, Michigan, United States
- Ypsilanti, Michigan, United States
- Rochester, Minnesota, United States
- Trenton, New Jersey, United States
- Lake Success, New York, United States
- The Bronx, New York, United States
- Cincinnati, Ohio, United States
- Springfield, Ohio, United States
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Tucson, Arizona, United States; Fountain Valley, California, United States; Ventura, California, United States; Aurora, Colorado, United States; Jacksonville, Florida, United States and 19 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.