the first affiliated hopital of Xiamen University
Xiamen, Fujian, 361003, China
Location status: Recruiting
NCT Number: NCT05841615
The close relationship between the increase of sympathetic tension, AF, and HTN cannot be ignored. In addition, the significant failure rate of PVI (20-50%) in the treatment of AF makes it very necessary to explore the effect of RDN on AF. Therefore, this study aims to compare the effects and safety of PVI alone and PVI combined with RDN with AF combined with HTN, which will open a new chapter for PVI combined with RDN in the treatment of AF.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Xiamen, Fujian, 361003, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
RDN: Percutaneous renal artery sympathetic radiofrequency ablation for both sides. For each side, a total of 13 targets were ablated. The ablation power was 8W~12W for 40 seconds
PVI: Pulmonary vein isolation was performed until the potential of each pulmonary vein disappeared under the guidance of the CARTO mapping system. Ablation of the top line and the bottom line of the left atrium was performed at the same time.
Time frame: within 2 years post operation
Fatal and nonfatal stroke
Time frame: within 2 years post operation
cerebral hemorrhage
Time frame: within 2 years post operation
acute myocardial infarction
Time frame: within 2 years post operation
cardiovascular death
Time frame: within 2 years post operation
Hospitalization for heart failure
Time frame: within 2 years post operation
elevation of blood pressure(mmHg, upper arm blood pressure electronic monitor)
Time frame: within 2 years post operation
left ventricular hypertrophy(mm, by Cardiac color ultrasound)
Time frame: within 2 years post operation
coronary revascularization(by coronary arteriography)
Time frame: within 2 years post operation
transient ischemic attack
Time frame: within 2 years post operation
renal insufficiency (eGFR ml/min, by ECT);
Time frame: within 2 years post operation
renal artery stenosis(by renal arteriography)
Time frame: within 2 years post operation
proteinuria(mg/L, PRM assay)
Time frame: within 2 years post operation
the recurrence rate of atrial fibrillation
Time frame: within 2 years post operation
the control rate of blood pressure
The First Affiliated Hospital of Xiamen University
Other
Evaluation of the Safety and Efficacy of Pulmonary Vein Isolation (PVI) Combined With Renal Denervation (RDN) in Patients With Atrial Fibrillation (AF) and Hypertension (HTN)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07316270
AF - Atrial Fibrillation, Arrhythmias, Cardiac
Hefei, Anhui, China
View Trial DetailsNCT04577859
AF - Atrial Fibrillation, Arrhythmias, Cardiac
Naples, Florida, United States
View Trial DetailsNCT07411170
AF - Atrial Fibrillation, Arrhythmias, Cardiac
View Trial DetailsNCT07583784
AF - Atrial Fibrillation, Arrhythmias, Cardiac
Gwangju, South Korea
View Trial Details