Clinical trial for AF - Atrial Fibrillation
Official title Pulmonary Vein Isolation (PVI) Combined With Renal Denervation (RDN) in Atrial Fibrillation (AF) and Hypertension (HTN)
ClinicalTrials.gov ID: NCT05841615
What this study is testing
- What it's testing
- This study wants to find out if combining a kidney nerve procedure with a heart rhythm treatment is safer or more effective than the heart treatment alone.
- Who it's for
- The study is looking for people who have both atrial fibrillation (an irregular heartbeat) and high blood pressure.
- What's involved
- Participants will receive a heart rhythm procedure called pulmonary vein isolation. Some will also get a kidney nerve procedure called renal denervation.
- Time commitment
- The source text does not specify the total duration or the number of visits required.
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 75
You may be able to join if
- 18\<age\<75years
- clinic blood pressure≥140/90mmHg or 24-hour ambulatory blood pressure monitoring average blood pressure ≥135/85mmHg
- Ecg diagnosis of atrial fibrillation ;
- who signed informed consent and were approved by the Ethics Committee of the First Affiliated Hospital of Xiamen University.
You likely can't join if
- pregnant women or lactating patients;
- Patients who were unsuitable for ablation before surgery （unilateral or bilateral renal artery shape and structure were found： renal artery stenosis...
- Patients who only have one kidney or have a history of kidney transplantation
- Patients with a history of renal arterial intervention or renal denervation
- identified secondary hypertension or Pseudo hypertension except for renal parenchymal hypertension;
- malignant tumors or end-stage diseases;
See the full eligibility criteria
- 18\<age\<75years
- clinic blood pressure≥140/90mmHg or 24-hour ambulatory blood pressure monitoring average blood pressure ≥135/85mmHg
- Ecg diagnosis of atrial fibrillation ;
- who signed informed consent and were approved by the Ethics Committee of the First Affiliated Hospital of Xiamen University.
- pregnant women or lactating patients;
- Patients who were unsuitable for ablation before surgery （unilateral or bilateral renal artery shape and structure were found： renal artery stenosis exceeding 50%, renal aneurysm, previous renal artery treatment...
- Patients who only have one kidney or have a history of kidney transplantation
- Patients with a history of renal arterial intervention or renal denervation
- identified secondary hypertension or Pseudo hypertension except for renal parenchymal hypertension;
- malignant tumors or end-stage diseases;
- Severe peripheral vascular disease, abdominal aortic aneurysm
- whose left atrium is larger than 55mm
- obvious bleeding tendency and blood system diseases;
- Severe peripheral vascular disease, abdominal aortic aneurysm;
- A history of the acute coronary syndrome within two weeks;
- acute or severe systemic infection;
- drug or alcohol dependence or refusal to sign informed consent.
- Other conditions that are not suitable for PVI and RDN
The study team makes the final eligibility decision.
Where it is enrolling
- Xiamen, Fujian, China
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, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Xiamen, Fujian, China. 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.