search
Back to results

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

Primary Purpose

AF - Atrial Fibrillation, HTN-Hypertension

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Renal Denervation operation
Pulmonary vein isolation
Sponsored by
The First Affiliated Hospital of Xiamen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for AF - Atrial Fibrillation focused on measuring Pulmonary Vein Isolation (PVI), Renal Denervation (RDN), Atrial Fibrillation (AF), Hypertension (HTN)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion 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. 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Experimental

    Arm Label

    PVI alone

    PVI and RDN

    Arm Description

    Participants only experience PVI operations

    Participants experience both PVI and RDN operations

    Outcomes

    Primary Outcome Measures

    Malignant end point event 1
    Fatal and nonfatal stroke
    Malignant end point event 2
    cerebral hemorrhage
    Malignant end point event 3
    acute myocardial infarction
    Malignant end point event 4
    cardiovascular death

    Secondary Outcome Measures

    Complex end point event 1
    Hospitalization for heart failure
    Complex end point event 2
    elevation of blood pressure(mmHg, upper arm blood pressure electronic monitor)
    Complex end point event 3
    left ventricular hypertrophy(mm, by Cardiac color ultrasound)
    Complex end point event 4
    coronary revascularization(by coronary arteriography)
    Complex end point event 5
    transient ischemic attack
    Complex end point event 6
    renal insufficiency (eGFR ml/min, by ECT);
    Complex end point event 7
    renal artery stenosis(by renal arteriography)
    Complex end point event 8
    proteinuria(mg/L, PRM assay)
    Complex end point event 9
    the recurrence rate of atrial fibrillation
    Complex end point event 10
    the control rate of blood pressure

    Full Information

    First Posted
    April 4, 2023
    Last Updated
    September 11, 2023
    Sponsor
    The First Affiliated Hospital of Xiamen University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05841615
    Brief Title
    Pulmonary Vein Isolation (PVI) Combined With Renal Denervation (RDN) in Atrial Fibrillation (AF) and Hypertension (HTN)
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    April 30, 2026 (Anticipated)
    Study Completion Date
    April 30, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The First Affiliated Hospital of Xiamen University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    AF - Atrial Fibrillation, HTN-Hypertension
    Keywords
    Pulmonary Vein Isolation (PVI), Renal Denervation (RDN), Atrial Fibrillation (AF), Hypertension (HTN)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PVI alone
    Arm Type
    Sham Comparator
    Arm Description
    Participants only experience PVI operations
    Arm Title
    PVI and RDN
    Arm Type
    Experimental
    Arm Description
    Participants experience both PVI and RDN operations
    Intervention Type
    Other
    Intervention Name(s)
    Renal Denervation operation
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Pulmonary vein isolation
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Malignant end point event 1
    Description
    Fatal and nonfatal stroke
    Time Frame
    within 2 years post operation
    Title
    Malignant end point event 2
    Description
    cerebral hemorrhage
    Time Frame
    within 2 years post operation
    Title
    Malignant end point event 3
    Description
    acute myocardial infarction
    Time Frame
    within 2 years post operation
    Title
    Malignant end point event 4
    Description
    cardiovascular death
    Time Frame
    within 2 years post operation
    Secondary Outcome Measure Information:
    Title
    Complex end point event 1
    Description
    Hospitalization for heart failure
    Time Frame
    within 2 years post operation
    Title
    Complex end point event 2
    Description
    elevation of blood pressure(mmHg, upper arm blood pressure electronic monitor)
    Time Frame
    within 2 years post operation
    Title
    Complex end point event 3
    Description
    left ventricular hypertrophy(mm, by Cardiac color ultrasound)
    Time Frame
    within 2 years post operation
    Title
    Complex end point event 4
    Description
    coronary revascularization(by coronary arteriography)
    Time Frame
    within 2 years post operation
    Title
    Complex end point event 5
    Description
    transient ischemic attack
    Time Frame
    within 2 years post operation
    Title
    Complex end point event 6
    Description
    renal insufficiency (eGFR ml/min, by ECT);
    Time Frame
    within 2 years post operation
    Title
    Complex end point event 7
    Description
    renal artery stenosis(by renal arteriography)
    Time Frame
    within 2 years post operation
    Title
    Complex end point event 8
    Description
    proteinuria(mg/L, PRM assay)
    Time Frame
    within 2 years post operation
    Title
    Complex end point event 9
    Description
    the recurrence rate of atrial fibrillation
    Time Frame
    within 2 years post operation
    Title
    Complex end point event 10
    Description
    the control rate of blood pressure
    Time Frame
    within 2 years post operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion 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. 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

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs