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New treatment option for Atrial Fibrillation - Symptomatic
Official title Low Voltage-Directed Catheter Ablation for Atrial Fibrillation
ClinicalTrials.gov ID: NCT03355456
What this study is testing
- What it's testing
- A two-pronged approach to evaluate long term success of non-paroxysmal ablation when using a: 1. specified low voltage-directed with pulmonary vein isolation (LD+PVI) approach compared to , 2.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- people must meet all of the following criteria:
- Non-Paroxysmal Atrial Fibrillation.
- Failed or intolerable to at least 1 one antiarrhythmic drug (AAD).
- 18-85 year of age at time of consent.
- Scheduled to undergo a clinically indicated AF ablation procedure.
You likely can't join if
- people will be excluded if any of the follow criteria are present:
- History of prior left-sided catheter or surgical ablation for AF or atypical atrial flutter, including MAZE or mini MAZE.
- Prior ablation for typical atrial flutter or left-sided ablation for WPW, AV node reentry tachycardia or focal ectopic atrial tachycardia may be...
- Uncontrolled heart Failure or NYHA Class IIIb or IV heart failure.
- Ejection Fraction \< 0.20.
- Active ventricular tachycardia requiring treatment with catheter ablation or anti-arrhythmic drug within the last 6 months.
See the full eligibility criteria
- people must meet all of the following criteria:
- Non-Paroxysmal Atrial Fibrillation.
- Failed or intolerable to at least 1 one antiarrhythmic drug (AAD).
- 18-85 year of age at time of consent.
- Scheduled to undergo a clinically indicated AF ablation procedure.
- Able and willing to comply with all protocol visit requirements.
- Signed Patient Informed Consent (ICF).
- Presence of low voltage in the left atrium on 3-D map during index catheter ablation procedure
- people will be excluded if any of the follow criteria are present:
- History of prior left-sided catheter or surgical ablation for AF or atypical atrial flutter, including MAZE or mini MAZE.
- Prior ablation for typical atrial flutter or left-sided ablation for WPW, AV node reentry tachycardia or focal ectopic atrial tachycardia may be included.
- Uncontrolled heart Failure or NYHA Class IIIb or IV heart failure.
- Ejection Fraction \< 0.20.
- Active ventricular tachycardia requiring treatment with catheter ablation or anti-arrhythmic drug within the last 6 months.
- Left atrial size \> 60 mm diameter on echocardiogram.
- "Long standing" persistent AF defined as \> or = 1 year of continuous atrial fibrillation at the time of enrollment.
- Severe pulmonary hypertension (PAP \> 70 mmHg)
- Unstable valvular disease.
- AF secondary to electrolyte imbalance, thyroid disease or reversible non- cardiac cause.
- Poor candidate for general anesthesia.
- Anticipated survival \< 1 year.
- MI or CABG within 3 months.
- Left atrial thrombus in pre-procedure imaging within 4 weeks of the ablation procedure.
- Any documented thromboembolic event within 6 months of the ablation procedure.
- Contraindication to anticoagulation.
- Inability to have implantable monitoring device for atrial fibrillation burden with no pre-existing cardiac device that can monitor atrial arrhythmias OR inability to wear external Holter Monitor continuously for 4...
- Significant congenital anomaly or medical condition that may affect the integrity of study data.
- Women who are pregnant - pregnancy test required if pre-menopausal or non-sterile.
- Active enrollment in another investigational study involving a drug or device.
- Inability to undergo complete voltage mapping in normal sinus rhythm - see intraprocedural protocol.
- Presence of any medical or psychological condition or medical non-compliance history that may adversely impact study outcomes.
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
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 - 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, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.