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Compares treatment options for Atrial Fibrillation
Official title Renal Denervation + PVI vs PVI Alone for Persistent AF
ClinicalTrials.gov ID: NCT05116384
What this study is testing
- What it's testing
- Pulmonary vein isolation (PVI) is the cornerstone of ablation for atrial fibrillation (AF). Increased cardiac sympathetic stimulation can facilitate AF and reduction can be accomplished by renal artery denervation (RDN).
- 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 and older
You may be able to join if
- Age \> 18 years
- Symptomatic persistent AF eligible for referral for PVI based on current guidelines1 (persistent AF defined as continuation \> 7 days and up to 1...
- No prior history of HTN or HTN controlled on medical therapy (defined as SBP \<140 mm Hg and DBP \<85 mm Hg)
- Renal vasculature accessible as determined by pre-procedural renal magnetic resonance angiogram
- Willingness to undergo ILR placement
You likely can't join if
- Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation)
- Prior left atrial ablation for an atrial arrhythmia
- NYHA class IV congestive heart failure or LVEF \< 25%
- Paroxysmal AF, or longstanding persistent AF (duration \> 1 year)
- Coronary revascularization or valve surgery within 3 months
- Prior valve surgery using a mechanical prosthesis
See the full eligibility criteria
- Age \> 18 years
- Symptomatic persistent AF eligible for referral for PVI based on current guidelines1 (persistent AF defined as continuation \> 7 days and up to 1 year)
- No prior history of HTN or HTN controlled on medical therapy (defined as SBP \<140 mm Hg and DBP \<85 mm Hg)
- Renal vasculature accessible as determined by pre-procedural renal magnetic resonance angiogram
- Willingness to undergo ILR placement
- Willingness to comply with post-procedural follow-up requirements and to sign informed consent.
- Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation)
- Prior left atrial ablation for an atrial arrhythmia
- NYHA class IV congestive heart failure or LVEF \< 25%
- Paroxysmal AF, or longstanding persistent AF (duration \> 1 year)
- Coronary revascularization or valve surgery within 3 months
- Prior valve surgery using a mechanical prosthesis
- Renal artery anatomy that is ineligible for treatment including:
- Predicted inability to access renal vasculature
- Main renal arteries \< 4 mm in diameter or \< 20 mm in length.
- Hemodynamically or anatomically significant renal artery abnormality or stenosis
- A history of prior renal artery intervention including balloon angioplasty or stenting that precludes a possibility of ablation treatment
- Multiple main renal arteries to either kidney
- An estimated glomerular filtration rate (eGFR) \< 45mL/min/1.73m2, using the MDRD calculation
- Life expectancy \<1 year for any medical condition
The study team makes the final eligibility decision.
Where it's taking place
- Short Hills, New Jersey, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Short Hills, New Jersey, 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.