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
About this trial
This is an interventional treatment trial for Sinus Bradycardia
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.
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
NCT ID
NCT05021627
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
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
Learn more about this trial
Cardiac Autonomic Nerve Improvement and Pacemaker Therapy in Patients With Sinus Bradycardia
We'll reach out to this number within 24 hrs