NCT06587672

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
15mo left

Started Sep 2024

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Sep 2024Jul 2027

First Submitted

Initial submission to the registry

August 6, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

September 15, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

September 19, 2024

Status Verified

August 1, 2024

Enrollment Period

1.9 years

First QC Date

August 6, 2024

Last Update Submit

September 4, 2024

Conditions

PacemakerAtrioventricular BlockClinical TrialsPacing

Keywords

Leadless pacingAtrioventricular synchronyAtrioventricular blockAtrial contraction

Outcome Measures

Primary Outcomes (2)

  • Complete the survey questionnair before implanting a pacemaker

    Complete the survey questionnair

    1 day before implanting a pacemaker

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

    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 months post-implant

Secondary Outcomes (14)

  • Immediate success rate of Micra AV implantation.

    During implantation on day 0

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

    6, 12 months post-implant

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

    3, 6, 12months post-implant

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

    3, 6, 12 months post-implant

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

    3, 6, 12 months post-implant

  • +9 more secondary outcomes

Study Arms (1)

Patients received Micra AV implantation

Patients received Micra AV implantation

Device: Micra AV implantation

Interventions

Micra AV implantationDEVICE

Patients received Micra AV implantation

Patients received Micra AV implantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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)".All patients should sign written informed consent for agreement of the implantation procedure.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fu Wai Hospital

Beijing, Beijing Municipality, 100037, China

Location

Peking University First Hospital

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (6)

  • Ann HW, Ahn JY, Jeon YD, Jung IY, Jeong SJ, Joung B, Lee M, Ku NS, Han SH, Kim JM, Choi JY. Incidence of and risk factors for infectious complications in patients with cardiac device implantation. Int J Infect Dis. 2015 Jul;36:9-14. doi: 10.1016/j.ijid.2015.05.011. Epub 2015 May 14.

    PMID: 25980618BACKGROUND

  • Wilkoff BL. How to treat and identify device infections. Heart Rhythm. 2007 Nov;4(11):1467-70. doi: 10.1016/j.hrthm.2007.08.007. Epub 2007 Aug 11. No abstract available.

    PMID: 17954409BACKGROUND

  • Johansen JB, Jorgensen OD, Moller M, Arnsbo P, Mortensen PT, Nielsen JC. Infection after pacemaker implantation: infection rates and risk factors associated with infection in a population-based cohort study of 46299 consecutive patients. Eur Heart J. 2011 Apr;32(8):991-8. doi: 10.1093/eurheartj/ehq497. Epub 2011 Jan 20.

    PMID: 21252172BACKGROUND

  • Knops RE, Tjong FV, Neuzil P, Sperzel J, Miller MA, Petru J, Simon J, Sediva L, de Groot JR, Dukkipati SR, Koruth JS, Wilde AA, Kautzner J, Reddy VY. Chronic performance of a leadless cardiac pacemaker: 1-year follow-up of the LEADLESS trial. J Am Coll Cardiol. 2015 Apr 21;65(15):1497-504. doi: 10.1016/j.jacc.2015.02.022.

    PMID: 25881930BACKGROUND

  • Reddy VY, Knops RE, Sperzel J, Miller MA, Petru J, Simon J, Sediva L, de Groot JR, Tjong FV, Jacobson P, Ostrosff A, Dukkipati SR, Koruth JS, Wilde AA, Kautzner J, Neuzil P. Permanent leadless cardiac pacing: results of the LEADLESS trial. Circulation. 2014 Apr 8;129(14):1466-71. doi: 10.1161/CIRCULATIONAHA.113.006987. Epub 2014 Mar 24.

    PMID: 24664277BACKGROUND

  • Reynolds DW, Ritter P. A Leadless Intracardiac Transcatheter Pacing System. N Engl J Med. 2016 Jun 30;374(26):2604-5. doi: 10.1056/NEJMc1604852. No abstract available.

    PMID: 27355552BACKGROUND

MeSH Terms

Conditions

Atrioventricular Block

Condition Hierarchy (Ancestors)

Heart BlockArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Xiaohan Fan, MD,PhD

    Chinese Academy of Medical Sciences, Fuwai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaohan Fan

CONTACT

+861088322393fanxiaohan@fuwaihospital.org

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 6, 2024

First Posted

September 19, 2024

Study Start

September 15, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2027

Last Updated

September 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)