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Cardiac Autonomic Nerve Improvement and Pacemaker Therapy in Patients With Sinus Bradycardia

Primary Purpose

Sinus Bradycardia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cardiac autonomic nerve modification
Pacemaker implantation
Sponsored by
Shanghai Chest Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sinus Bradycardia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged 18 to 80 years old;
  2. Symptomatic sinus bradycardia;
  3. Not meet the class I indications for pacemaker implantation.

Exclusion Criteria:

  1. Structural heart disease, heart surgery history;
  2. Drug-induced SB, sinus pause >2.0 s, positive atropine test, corrected sinus node recovery time (cSNRT) >525 ms;
  3. Any atrial or ventricular arrhythmia, or a history of ablation procedures to treat atrial tachyarrhythmias;
  4. With Significant congenital heart disease, ejection fraction was <40% measured by echocardiography;
  5. Allergic to contrast media;
  6. Contraindication to anticoagulation medications;
  7. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);

9. Poor general health; 10.Life expectancy less than 6 months.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Cardiac autonomic nerve modification

    Pacemaker

    Arm Description

    Outcomes

    Primary Outcome Measures

    Symptom score after operation
    Each patient subjectively assessed his or her SB-related symptom, including dizziness, fatigue, and palpitation, on a score of 1 to 10 points (mildtosevere). The total SB-related symptom score for each patient was calculated as the sum of all scores for individual symptoms.

    Secondary Outcome Measures

    Quality of life score
    The Medical Outcomes Study Short-Form 36 Health Survey (SF-36) was used to assess quality of life (QoL) at baseline and 12 months after ablation. The self-administration mode was strictly followed for QoL surveys. TheSF-36 assesses 8 specific QoL domains, namely physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problem, and mental health. For each subscale, scores were transformed to a scale ranging from 0 to 100, with lower scores representing a lower QoL.
    Psychological quality score
    The Zung Self-Rating Depression Scale is a short self administered survey to quantify the depressed status of a patient. There are 20 items on the scale that rate the four common characteristics of depression: the pervasive effect, the physiological equivalents, other disturbances, and psychomotor activities. There are ten positively worded and ten negatively worded questions. Each question is scored on a scale of 1-4 (a little of the time, some of the time, good part of the time, most of the time).

    Full Information

    First Posted
    August 15, 2021
    Last Updated
    August 19, 2021
    Sponsor
    Shanghai Chest Hospital
    Collaborators
    The Second Affiliated Hospital of Shandong University of traditional Chinese Medicine, The Second People's Hospital of Yuhuan City
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05021627
    Brief Title
    Cardiac Autonomic Nerve Improvement and Pacemaker Therapy in Patients With Sinus Bradycardia
    Official Title
    A Multicenter Randomized Controlled Study of Cardiac Autonomic Nerve Improvement and Pacemaker Therapy in Patients With Sinus Bradycardia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2021 (Anticipated)
    Primary Completion Date
    August 31, 2026 (Anticipated)
    Study Completion Date
    August 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai Chest Hospital
    Collaborators
    The Second Affiliated Hospital of Shandong University of traditional Chinese Medicine, The Second People's Hospital of Yuhuan City

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is a multicenter randomized controlled study. By comparing patients with sinus bradycardia undergoing cardiac autonomic ganglion ablation and pacemaker therapy, and long-term follow-up to evaluate its safety and effectiveness after surgery, in order to evaluate the safety and effectiveness of cardiac autonomic ganglion ablation in the treatment of sinus bradycardia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sinus Bradycardia

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Cardiac autonomic nerve modification
    Arm Type
    Experimental
    Arm Title
    Pacemaker
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Cardiac autonomic nerve modification
    Intervention Description
    Patients with sinus bradycardia undergoing cardiac autonomic ganglion ablation. Specific anatomic ablation of the 4 major left atrial GP and aorta-superior vena cava (Ao-SVC) GP was performed. Briefly, catheter ablation was performed under the guidance of an electroanatomic mapping system (CARTO,BiosenseWebster,DiamondBar,California). After completed the electroanatomic mapping of the left atrium was complete and pulmonary vein (PV) ostia identified, presumed GP clusters were ablated 1 to 2cm outside the PV-left atrium junctions at the following sites: the left superolateral area (leftsuperior GP[LSGP]), the leftinfer oposterior area(left inferior GP[LIGP]), the right superoanterior area (rightanterior GP[RAGP]), the right inferoposterior area(right inferior GP[RIGP]), and the Ao-SVC fat pad (Ao-SVCGP), and in that sequence.
    Intervention Type
    Procedure
    Intervention Name(s)
    Pacemaker implantation
    Intervention Description
    Patients with sinus bradycardia received pacemaker implantation. The patient lay flat on the bed, puncture the subclavian vein and insert two guide wires. Cut the skin under the guide wire to make a skin bag, and stop bleeding accurately to avoid continuous bleeding of the skin bag. The pacemaker electrode is inserted into the heart cavity by guiding the guide wire, one is placed in the ventricle and the other in the atrium, and the corresponding parameters of the electrode, such as pacing threshold, impedance, etc., are measured at the same time. If the parameters are good, fix the electrode, connect the electrode with the pacemaker, place the pacemaker in the skin bag, fix the pacemaker and electrode, suture the skin layer by layer, and the operation is completed.
    Primary Outcome Measure Information:
    Title
    Symptom score after operation
    Description
    Each patient subjectively assessed his or her SB-related symptom, including dizziness, fatigue, and palpitation, on a score of 1 to 10 points (mildtosevere). The total SB-related symptom score for each patient was calculated as the sum of all scores for individual symptoms.
    Time Frame
    48 months
    Secondary Outcome Measure Information:
    Title
    Quality of life score
    Description
    The Medical Outcomes Study Short-Form 36 Health Survey (SF-36) was used to assess quality of life (QoL) at baseline and 12 months after ablation. The self-administration mode was strictly followed for QoL surveys. TheSF-36 assesses 8 specific QoL domains, namely physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problem, and mental health. For each subscale, scores were transformed to a scale ranging from 0 to 100, with lower scores representing a lower QoL.
    Time Frame
    48 months
    Title
    Psychological quality score
    Description
    The Zung Self-Rating Depression Scale is a short self administered survey to quantify the depressed status of a patient. There are 20 items on the scale that rate the four common characteristics of depression: the pervasive effect, the physiological equivalents, other disturbances, and psychomotor activities. There are ten positively worded and ten negatively worded questions. Each question is scored on a scale of 1-4 (a little of the time, some of the time, good part of the time, most of the time).
    Time Frame
    48 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged 18 to 80 years old; Symptomatic sinus bradycardia; Not meet the class I indications for pacemaker implantation. Exclusion Criteria: Structural heart disease, heart surgery history; Drug-induced SB, sinus pause >2.0 s, positive atropine test, corrected sinus node recovery time (cSNRT) >525 ms; Any atrial or ventricular arrhythmia, or a history of ablation procedures to treat atrial tachyarrhythmias; With Significant congenital heart disease, ejection fraction was <40% measured by echocardiography; Allergic to contrast media; Contraindication to anticoagulation medications; Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD); 9. Poor general health; 10.Life expectancy less than 6 months.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xu Liu, MD
    Phone
    +8613052320103
    Email
    heartlx@sina.com

    12. IPD Sharing Statement

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    Cardiac Autonomic Nerve Improvement and Pacemaker Therapy in Patients With Sinus Bradycardia

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