AF - Atrial FibrillationNCT05841615
Pulmonary Vein Isolation (PVI) Combined With Renal Denervation (RDN) in Atrial Fibrillation (AF) and Hypertension (HTN)
A study testing Renal Denervation operation and Pulmonary vein isolation in people with AF - Atrial Fibrillation and HTN-Hypertension, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- AF - Atrial Fibrillation, HTN-Hypertension
- What is being tested?
- Renal Denervation operation and Pulmonary vein isolation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the first affiliated hopital of Xiamen University
Xiamen, Fujian, 361003
Ziguan Zhang, +8618750227289, 116504153@qq.com
About this study
Official title: 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)
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.
- Conditions
- AF - Atrial Fibrillation, HTN-Hypertension
- Being tested
- Renal Denervation operation, Pulmonary vein isolation
- Keywords
- Pulmonary Vein Isolation (PVI), Renal Denervation (RDN), Atrial Fibrillation (AF), Hypertension (HTN)
- Medical subject headings
- Atrial Fibrillation, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal Denervation operationOther
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
Pulmonary vein isolationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PVI alone | Sham comparator | Participants only experience PVI operations Receives: Other: Pulmonary vein isolation |
| PVI and RDN | Experimental | Participants experience both PVI and RDN operations Receives: Other: Renal Denervation operation; Other: Pulmonary vein isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malignant end point event 1
Fatal and nonfatal stroke
Measured: within 2 years post operation
Malignant end point event 2
cerebral hemorrhage
Measured: within 2 years post operation
Malignant end point event 3
acute myocardial infarction
Measured: within 2 years post operation
Malignant end point event 4
cardiovascular death
Measured: within 2 years post operation
Secondary outcomes (10)
Complex end point event 1
Hospitalization for heart failure
Measured: within 2 years post operation
Complex end point event 2
elevation of blood pressure(mmHg, upper arm blood pressure electronic monitor)
Measured: within 2 years post operation
Complex end point event 3
left ventricular hypertrophy(mm, by Cardiac color ultrasound)
Measured: within 2 years post operation
Complex end point event 4
coronary revascularization(by coronary arteriography)
Measured: within 2 years post operation
Complex end point event 5
transient ischemic attack
Measured: within 2 years post operation
Complex end point event 6
renal insufficiency (eGFR ml/min, by ECT);
Measured: within 2 years post operation
Complex end point event 7
renal artery stenosis(by renal arteriography)
Measured: within 2 years post operation
Complex end point event 8
proteinuria(mg/L, PRM assay)
Measured: within 2 years post operation
Complex end point event 9
the recurrence rate of atrial fibrillation
Measured: within 2 years post operation
Complex end point event 10
the control rate of blood pressure
Measured: within 2 years post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Sep 2023
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AF - Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhengrong Huang, The First Affiliated Hospital of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841615
- Sponsor's protocol ID
- 2022-RDN and PVI
- Status last verified
- Mar 2024
- First submitted
- 4 Apr 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05841615
- Acronym / sponsor ID
- 2022-RDN and PVI
- Conditions
- AF - Atrial Fibrillation, HTN-Hypertension
- Keywords
- Pulmonary Vein Isolation (PVI), Renal Denervation (RDN), Atrial Fibrillation (AF), Hypertension (HTN)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVI alone | Sham comparator | Other: Pulmonary vein isolationParticipants only experience PVI operations |
| PVI and RDN | Experimental | Other: Renal Denervation operation, Other: Pulmonary vein isolationParticipants experience both PVI and RDN operations |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal Denervation operationRDN: 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 | PVI and RDN |
| Pulmonary vein isolationPVI: 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. | Other | PVI alone, PVI and RDN |
Primary outcome
Malignant end point event 1
Time frame: within 2 years post operation
Fatal and nonfatal stroke
Malignant end point event 2
Time frame: within 2 years post operation
cerebral hemorrhage
Malignant end point event 3
Time frame: within 2 years post operation
acute myocardial infarction
Malignant end point event 4
Time frame: within 2 years post operation
cardiovascular death
10 secondary outcomes
Complex end point event 1
Time frame: within 2 years post operation
Complex end point event 2
Time frame: within 2 years post operation
Complex end point event 3
Time frame: within 2 years post operation
Complex end point event 4
Time frame: within 2 years post operation
Complex end point event 5
Time frame: within 2 years post operation
Complex end point event 6
Time frame: within 2 years post operation
Complex end point event 7
Time frame: within 2 years post operation
Complex end point event 8
Time frame: within 2 years post operation
Complex end point event 9
Time frame: within 2 years post operation
Complex end point event 10
Time frame: within 2 years post operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal Denervation operation and Pulmonary vein isolation in people with AF - Atrial Fibrillation and HTN-Hypertension, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malignant end point event 1 (time frame: within 2 years post operation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.