Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06587672

Factors Affecting Selection of Leadless Pacemaker and Atrioventricular Synchronous Pacing Status

This is a multicenter, prospective, observational study ,the aim of this study is to find factors affecting selection of double-chamber leadless pacemaker in patients with atrioventricular block and ambulatory atrioventricular synchronous pacing status over time using a leadless ventricular pacemaker.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fu Wai Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

About this study

Traditional pacemakers consist of a pulse generator and leads. Infections of the pulse generator pocket and lead-related complications are unavoidable issues in the application oftraditional pacemakers.Leadless pacemakers have emerged to address complications associated with the pacemaker pocket and leads in specific patients.The initial design of leadless pacemakers focused on single-chamber (right ventricular)sensing and pacing,However, patients with sinus rhythm may experience pacemakersyndrome symptoms due to atrioventricular desynchrony. Furthermore, a high proportion of atrioventricular dyssynchronous ventricular pacing might increase hospitalization rates for atrial fibrillation and heart failure.Recent developments in leadless dual-chamber pacemakersutilize a built-in triaxial accelerometer.This study aims to investigate factors considered by patients with atrioventricular block and clinical pacemaker implanting physicians when make sure the use of Micra AV. 2). It also seeks to evaluate the atrioventricular synchrony of Micra AV pacing in patients during both exercise and rest, while analyzing factors that influence the AV synchrony.For all screened patients, a questionnaire is required to be finished with data including age, gender, occupation, educational level, clinical history, comorbidities, previous infections, history of implanted electronic devices, economic status, and medical insurance conditions. At same time, all physicians are asked to complete a questionnaire for analyzing the factors influencing the decision of device option.An ambulatory electrocardiogram will be performed at 3 months, 6 months, and 1 year follow-up after device implantation. Data regarding the proportion of atrioventricular Research Protocol Template (Observational Study)_V1.0_2023.10.04 7/10 synchrony, atrial sensing atrial contraction mechanical wave (A4) threshold, ventricular pacing threshold, sensing, and impedance will be tested and collected. Postoperative exercise related symptoms and adverse events will be routinely tracked.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with atrioventricular conduction block, meeting the indications for dual-chamber leadless pacemakers as per the "Chinese Expert Consensus on Clinical Application of Leadless Pacemakers (2022)".
  • Age ≥18 years.
  • Expected lifespan ≥1 year.
  • Consent to sign an informed consent form and cooperate in the collection of baseline data and subsequent follow-ups

Exclusion criteria

  • Patients anticipated to have a high ventricular pacing proportion (>40%) and with left ventricular ejection fraction less than 50%.
  • Patients with persistent atrial fibrillation and a high expected ventricular pacing proportion.
  • Post-tricuspid valve mechanical valve replacement surgery.
  • Patients with inferior vena cava pathway anomalies, precluding passage of the leadless pacemaker's delivery sheath.
  • Patients with an expected lifespan of less than 1 year. 6 Patients who are pregnant, planning pregnancy, or undergoing cardiac transplantation.

Treatment and study plan

Micra AV implantation

Device

Patients received Micra AV implantation

Primary outcomes

  1. Complete the survey questionnair before implanting a pacemaker

    Time frame: 1 day before implanting a pacemaker

    Complete the survey questionnair

  2. The percentage of atrioventricular synchrony at 3 months after Micra AV implantation.

    Time frame: 3 months post-implant

    The percentage of atrioventricular synchrony will be calculated based on the recording of a 20-minute resting period in the outpatient consulting room, via dividing the total number of AV synchronous cycles by the total number of cardiac cycles recoded by a Holter. An AV synchronous cycle will be defined as a paced or sensed ventricular beat within 300 ms following a surface ECG confirmed P-wave.

Secondary outcomes

  1. Immediate success rate of Micra AV implantation.

    Time frame: During implantation on day 0

    Successfully implant a Micra AV during procedure.

  2. The percentage of atrioventricular synchrony at 6, 12 months after Micra AV implantation.

    Time frame: 6, 12 months post-implant

    The percentage of atrioventricular synchrony will be calculated based on the recording of a 20-minute resting period in the outpatient consulting room, via dividing the total number of AV synchronous cycles by the total number of cardiac cycles recoded by a Holter. An AV synchronous cycle will be defined as a paced or sensed ventricular beat within 300 ms following a surface ECG confirmed P-wave.

  3. Ventricular pacing threshold, at 3 months, 6 months, and 1 year after Micra AV implantation.

    Time frame: 3, 6, 12months post-implant

    Measuring the ventricular pacing threshold by a programmer at the outpatient clinic at 3,6 and 12 month.

  4. Ventricular sensing at 3 months, 6 months, and 1 year after Micra AV implantation.

    Time frame: 3, 6, 12 months post-implant

    Measuring ventricular sensing by a programmer at the outpatient clinic at 3,6 and 12 month.

  5. Impedance at 3 months, 6months, and 1 year after Micra AV implantation.

    Time frame: 3, 6, 12 months post-implant

    Measuring Impedance by a programmer at the outpatient clinic at 3,6 and 12 month.

  6. Major complications related to the device implantation at perioperative period, and 3, 6, 9, 12 months after Micra AV implantation

    Time frame: Days 0,1 and 3, 6, 9, 12 months post- implant

    Major complations related to the device implantation include, pericardial effusion, dislodgement, threshold elevation or loss of capture, infection, etc.

  7. All-cause mortality rates at 3 months, 6 months, and 1 year after Micra AV implantation.

    Time frame: 3, 6, 9, 12 months post-implant

    These data will be collected at the outpatient clinic at 3,6 and 12 month, 9-month follow-up will be conducted via telephone.

  8. Rehospitalization events related to heart failure at 3 months, 6 months, and 1year after Micra AV implantation.

    Time frame: 3, 6, 12 months post-implant

    Rehospitalization events due to heart failure at 3 months, 6 months, and 1year after Micra AV implantation.

  9. Tachycardia related to the pacemaker, or adverse events related to the device or algorithm at 3, 6, 12 months after Micra AV implantation.

    Time frame: 3,6,12 months post-implant

    Tachycardia or or adverse events related to the device or algorithm during the follow-up

  10. Left venriculat ejection fraction measured by echocardiography at 6, 12 months after Micra AV implanted

    Time frame: 6, 12 months post-implant

    Left venriculat ejection fraction measured by echocardiography.

  11. Left ventricular end-diastolic diameter measured by echocardiography at 6, 12 months after Micra AV implantation.

    Time frame: 6, 12 months post-implant

    Left ventricular end-diastolic diameter measured by echocardiography

  12. Parameter adjustment events related to the synchrony less than 70% at 3, 6, 12 months after Micra AV implantation..

    Time frame: 3, 6, 12months post-implant

    Parameter adjustment event will be defined as optimamizing the pacemaker parameters due to synchrony less than 70%.

  13. Arrhythmias events at 3, 6, 12 months after Micra AV implantion

    Time frame: 3, 6, 12months post-implant

    All kinds of arrhythmias events recorded via electrocardiogram or device during the follow up

  14. Syncope events at 3, 6, 12 months after Micra AV implantion

    Time frame: 3, 6, 12months post-implant

    Syncope events during the follow up

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaohan Fan

CONTACT

[email protected]

+861088322393 ext. +861088322393

Sponsors and collaborators

Lead sponsor

Xiaohan Fan

Other

Collaborators

  • Beijing Friendship Hospital
  • Beijing Hospital
  • Peking University First Hospital
  • Tianjin Chest Hospital

Registry information

Official study title

Factors Affecting Selection of Leadless Pacemaker in Patients With Atrioventricular Block and Atrioventricular Synchronous Pacing Status With a Micra AV: a Multicenter, Prospective, Observational Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.