Studying Routine Patient Care With BIOTRONIK Devices That Allow a More Natural Heart Stimulation

N/ANot Yet RecruitingNCT07393009

Biotronik SE & Co. KG1,000 enrolled

Overview

The registry is designed to assess outcome, performance and residual safety aspects of BIOTRONIK products which are used in the context of CSP based on long-term data from an unselected, real-life clinical set-up.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Cardiac Pacing Cardiac Pacemaker Implantable Cardioverter Defibrillator Cardiac Resynchronization Therapy Devices Bradycardia Tachycardia Heart Failure

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Guideline indication for pacemaker or cardiac resynchronization therapy with or without defibrillation function (CRT-P/-D) * Patient is intended for a de novo implantation and LBBAP therapy with an investigational generator and an investigational lead OR has just been implanted with an investigational generator and an investigational lead positioned permanently deep within the intraventricular septum and has not yet been discharged from the hospital OR transitions from the BIO\|MASTER.CSP study * Ability to understand the nature of the study * Ability and willingness to perform all follow-up visits * Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring concept Exclusion Criteria: * Planned dation from intended use * Planned for cardiac surgical procedures, heart transplantation or interventional measures other than the study procedure within one year after enrollment * Life-expectancy less than 12 months * Pregnant or breast feeding * Age less than 18 years * Participation in an interventional clinical investigation, except for submodules within this study.

Outcomes

Primary Outcomes

SADE-d free rate related to any investigatonal device

Rate of serious adverse device effects possible, probable or causal related to any investigational device.

Time frame: throughout study duration, average of 4 years; annual evaluations

Rate of successful acute implantation in LBBAP using investigational devices in LBBAP

All implantations, in which the investigator decides to leave the Solia CSP S pacing lead permanently deep within the intraventricular septum are counted as acute success.

Time frame: Day 1

Capture type at implantation

The investigator confirms the type of pacing capture for any implantation in which the pacing lead is permanently positioned deep within the interventricular septum. Success rates for LBBAP and CSP are determined based on ECG parameters.

Time frame: Day 1

Long-term maintenance of LBBAP

The investigator is asked to assess the effectiveness of LBBAP during follow-up based on the interpretation of a 12-lead ECG recording.

Time frame: throughout study duration, average of 4 years; annual evaluations

Electrical parameters - pacing threshold

The investigators will be asked to record the pacing thresholds (Volts) of the LBBAP leads at a pulse width of 0.4 ms.

Time frame: throughout study duration, average of 4 years; annual evaluations

Electrical parameters - sensing amplitude

The investigators will be asked to record the sensing amplitude (Millivolts) of the LBBAP leads.

Time frame: throughout study duration, average of 4 years; annual evaluations

Electrical parameters - pacing impedance

The investigators will be asked to record the lead pacing impedance (Ohms) of the LBBAP leads.

Time frame: throughout study duration, average of 4 years; annual evaluations

Studying Routine Patient Care With BIOTRONIK Devices That Allow a More Natural Heart Stimulation

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Central Contacts