Pulmonary Vein Isolation (PVI) Combined With Renal Denervation (RDN) in Atrial Fibrillation (AF) and Hypertension (HTN)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 18

- 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.

Exclusion Criteria:

- 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 interventional surgery, renal artery malformation, renal artery diameter < 4mm or length of treatable segment < 20mm） - 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05841615
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	The First Affiliated Hospital of Xiamen University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	AF - Atrial Fibrillation, HTN-Hypertension

Arms & Interventions

Arms

Sham Comparator: PVI alone

Participants only experience PVI operations

Experimental: PVI and RDN

Participants experience both PVI and RDN operations

Interventions

Other: - Renal Denervation operation

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

Other: - Pulmonary vein isolation

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.

Contact a Trial Team

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