About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Micra AV implantation
Device
Patients received Micra AV implantation

Treatment groups

112 Participants

are divided into 1 treatment group

Group A: Patients received Micra AV implantation1 intervention

Trial outcomes

Primary outcomes

1

Complete the survey questionnair before implanting a pacemaker

Complete the survey questionnair

Time frame

1 day before implanting a pacemaker

2

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.

Time frame

3 months post-implant

Secondary outcomes

1

Immediate success rate of Micra AV implantation.

Successfully implant a Micra AV during procedure.

Time frame

During implantation on day 0

2

The percentage of atrioventricular synchrony at 6, 12 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.

Time frame

6, 12 months post-implant

3

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

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

Time frame

3, 6, 12months post-implant

4

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

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

Time frame

3, 6, 12 months post-implant

Factors Affecting Selection of Leadless Pacemaker and Atrioventricular Synchronous Pacing Status

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial population

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts