BIO|MASTER.CSP Study

N/AActive Not RecruitingNCT06620237

Biotronik SE & Co. KG152 enrolled

Overview

The goal of this clinical study is to test the clinical safety and performance of the Amvia pacemakers and the Solia CSP S lead when used for left bundle branch area pacing (LBBAP). The patient population consist of patients with cardiac pacemaker indication or cardiac resynchronization therapy indication and intended for implantation of a system with left bundle branch area stimulation. Participants will visit sites at enrollment in the study, at implantation and pre-hospital discharge, 1-, 6- and 12-month follow-up visits. Additional annual follow-up(s) may apply until study termination after regulatory approval of Solia CSP S. The total duration of the clinical investigation is expected to be until September 2027, with last patient out (LPO). During the visits the regular pacemaker and lead measurement are performed. A 12-lead ECG is recorded to document intrinsic and ventricularly paced heart rhythm to assess left bundle branch area pacing. Programming of the pacemakers will be done according to the participant´s therapeutical needs. The study will be conducted in approximately 18 sites in Europe, Australia and New Zealand where more than one physician per site are expected to participate.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

152

Conditions

Cardiac Pacing, Artificial Cardiac Pacemaker, Artificial

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: For patient enrollment in the study all of the following inclusion criteria have to be fulfilled at the time of enrollment: * Standard indication for de novo pacemaker implantation or cardiac resynchronization therapy (CRT) * Patient is intended for implantation of a pacemaker or CRT-P system with left bundle branch area stimulation * Ability to understand the nature of the study * Ability and willingness to perform all follow-up visits at the study site * Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring concept Exclusion Criteria: Enrollment of a patient is not permitted if at least one of the following criteria is fulfilled: * Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months * Expected to receive heart transplantation or ventricular assist device within 12 months * Life-expectancy less than 12 months * Pregnant or breast feeding * Age less than 18 years * Participation in another interventional clinical investigation (according to the definition given in the CIP)

Locations (14)

Integral Healthcare

Adelaide, Australia

Victorian Heart Hospital

Clayton, Australia

Lyell McEwin Hospital

Elizabeth Vale, Australia

AZ Sint-Jan

Bruges, Belgium

Grand Hôpital de Charleroi

Charleroi, Belgium

UZ Gent - Universitair Ziekenhuis Gent

Ghent, Belgium

Clinique Saint-Pierre Ottignies

Ottignies, Belgium

Hopital de la Timone (CHU La Timone)

Marseille, France

Centre Hospitalier Metz-Thionville

Metz, France

Hôpital privé du Confluent

Nantes, France

...and 4 more locations

Outcomes

Primary Outcomes

Amvia related SADE-d free rate

rate of serious adverse device effects possible, probable or causal related to the Amvia pacemaker

Time frame: 6 months (183 days) after implantation

Solia CSP S related SADE-d free rate

rate of serious adverse device effects possible, probable or causal related to the Solia CSP S lead

Time frame: 6 months (183 days) after implantation

Secondary Outcomes

Amvia related SADE-d free rate

Rate of serious adverse device effects possible, probable or causal related to the Amvia pacemaker

Time frame: 12 months (365 days) after implantation

Solia CSP S related SADE-d free rate

Rate of serious adverse device effects possible, probable or causal related to the Solia CSP S lead

Time frame: 12 months (365 days) after implantation

Rate of successful acute CSP implantation of Solia CSP S

All implantations, in which the investigator decides to leave the Solia CSP S pacing lead permanently in the conduction system, are counted as acute success.

Time frame: At the day of implantation

Sensing performance

Investigators will be asked whether the sensing is adequate (yes/no decision)

Time frame: At the day of implantation and at the date of each in-office patient follow-up visit (1-, 6-, 12-month follow-up, and annual follow-up*) * please refer to study duration in study description section

Pacing performance

Investigators will be asked whether the pacing is adequate (yes/no decision)

Physiologic ventricular excitation

Investigators are asked to assess whether pacing in the left bundle branch area is still present based on the 12-lead ECG recording

Mid-term change in LVEF

Collection of left ventricular ejection fraction (LVEF) values

Time frame: At baseline, at the 6-month follow-up, at the 12-month follow-up and at all following annual in-office follow-ups*, if applicable; * please refer to study duration in study description section

Mid-term change in LVESV

Collection of left ventricular ejection systolic volume (LVESV) values

Mid-term change in quality of life, EQ-5D-5L (EuroQol) questionnaire

Collection of health-related quality of life questionnaires from the patient to monitor mid-term changes in the quality of life, analysis and reporting according to EuroQol methodology

Time frame: At baseline after patient enrollment prior to implantation, at the date of 6-month follow-up, at the 12-month follow-up and at all following annual in-office follow-ups*, if applicable; * please refer to study duration in study description section

Mid-term change in quality of life, SF-36 (Short Form Health Survey) questionnaire

Collection of health-related quality of life questionnaires from the patient to monitor mid-term changes in the quality of life, analysis and reporting according to item short form health survey (SF-36) standard methodology