Trial Outcomes & Findings for BIO|CONCEPT.Amvia Study (NCT NCT05610176)

Last Updated: 2025-07-24

Results Overview

Descriptive statistics of the investigational device related SADE-free rate after first implantation attempt will be calculated using a Kaplan-Meier estimate

Recruitment status

COMPLETED

Study phase

Target enrollment

52 participants

Primary outcome timeframe

12 months

Results posted on

2025-07-24

Participant Flow

52 patients were enrolled between the date of first patient in (November 23, 2022) and last patient in (May 25, 2023). Patients that were already enrolled at the time of the notification of enrollment stop (after the 50th implantation) were still admitted for implantation, thus leading to two more patients than specified in the protocol (N=50)l.

50 patients were planned to be enrolled according to the protocol. At the time of the notification of enrollment stop (after the 50th implantation), two additional patients were already enrolled, thus leading to a total of 52 enrolled patients. All enrolled patients provided written informed consent and were implanted with an investigational device.

Participant milestones

Participant milestones
Measure	Amvia Sky Pacemaker or CRT-P Implantation Patients implanted with an Amvia Sky pacemaker or CRT-P device Amvia Sky pacemaker or CRT-P device: Subjects with an indication for a pacemaker or CRT-P device were implanted with an Amvia Sky device of the Amvia/Solvia pacemaker family according to standard pacemaker implantation procedures. After implantation with an investigational device, the patients were seen by the investigator at pre-hospital discharge, 1-month, 3-months, and 12-months follow-up. All clinical procedures were performed according to clinical routine.
Overall Study STARTED	52
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Amvia Sky Pacemaker or CRT-P Implantation Patients implanted with an Amvia Sky pacemaker or CRT-P device Amvia Sky pacemaker or CRT-P device: Subjects with an indication for a pacemaker or CRT-P device were implanted with an Amvia Sky device of the Amvia/Solvia pacemaker family according to standard pacemaker implantation procedures. After implantation with an investigational device, the patients were seen by the investigator at pre-hospital discharge, 1-month, 3-months, and 12-months follow-up. All clinical procedures were performed according to clinical routine.
Overall Study Death	6

Baseline Characteristics

BIO|CONCEPT.Amvia Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Amvia Sky Pacemaker or CRT-P Implantation n=52 Participants Patients implanted with an Amvia Sky pacemaker or CRT-P device Amvia Sky pacemaker or CRT-P device: Subjects with an indication for a pacemaker or CRT-P device were implanted with an Amvia Sky device of the Amvia/Solvia pacemaker family according to standard pacemaker implantation procedures. After implantation with an investigational device, the patients were seen by the investigator at pre-hospital discharge, 1-month, 3-months, and 12-months follow-up. All clinical procedures were performed according to clinical routine.
Age, Continuous	75.2 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Caucasion	49 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Black	0 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Indigenous	1 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Other	1 Participants n=5 Participants
Region of Enrollment Australia	36 participants n=5 Participants
Region of Enrollment New Zealand	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: All 52 patients implanted with an investigational device contribute to the analysis of the SADE-free rate. Neither any of the 46 patients with regular study termination after 12 months, nor any of the 6 patients with premature study termination had any SADE. Thus, a 95% CI for the SADE-free rate could methodologically not be estimated with the Kaplan-Meier method, but instead with the binomial method.

Descriptive statistics of the investigational device related SADE-free rate after first implantation attempt will be calculated using a Kaplan-Meier estimate

Outcome measures

Outcome measures
Measure	Amvia Sky Pacemaker or CRT-P Implantation n=52 Participants Patients implanted with an Amvia Sky pacemaker or CRT-P device Amvia Sky pacemaker or CRT-P device: Subjects with an indication for a pacemaker or CRT-P device were implanted with an Amvia Sky device of the Amvia/Solvia pacemaker family according to standard pacemaker implantation procedures. After implantation with an investigational device, the patients were seen by the investigator at pre-hospital discharge, 1-month, 3-months, and 12-months follow-up. All clinical procedures were performed according to clinical routine.
Serious Adverse Device Effect (SADE)-Free Rate After 12 Months	52 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: The analysis population for right atrial lead parameters consists of those patients that were implanted with an atrial lead, i.e. patients with a dual- or triple-chamber device, and for whom a value was measured at the specified timepoint.

The sensing amplitude is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum voltage of the heart's intrinsic electrical signals that a pacemaker can detect through its leads to monitor the heart's natural activity and decide whether pacing is needed. In this case refering to the lead placed in the right atrium.

Outcome measures

Outcome measures
Measure	Amvia Sky Pacemaker or CRT-P Implantation n=39 Participants Patients implanted with an Amvia Sky pacemaker or CRT-P device Amvia Sky pacemaker or CRT-P device: Subjects with an indication for a pacemaker or CRT-P device were implanted with an Amvia Sky device of the Amvia/Solvia pacemaker family according to standard pacemaker implantation procedures. After implantation with an investigational device, the patients were seen by the investigator at pre-hospital discharge, 1-month, 3-months, and 12-months follow-up. All clinical procedures were performed according to clinical routine.
Right Atrial Sensing Amplitude	3.4 mV Standard Deviation 1.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

The pacing threshold is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum amount of electrical energy required to consistently depolarize the myocardium, thereby triggering a cardiac contraction. In this case refering to the lead placed in the right atrium.

Outcome measures

Outcome measures
Measure	Amvia Sky Pacemaker or CRT-P Implantation n=37 Participants Patients implanted with an Amvia Sky pacemaker or CRT-P device Amvia Sky pacemaker or CRT-P device: Subjects with an indication for a pacemaker or CRT-P device were implanted with an Amvia Sky device of the Amvia/Solvia pacemaker family according to standard pacemaker implantation procedures. After implantation with an investigational device, the patients were seen by the investigator at pre-hospital discharge, 1-month, 3-months, and 12-months follow-up. All clinical procedures were performed according to clinical routine.
Right Atrial Pacing Threshold	0.9 V Standard Deviation 0.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: The analysis population for right ventricular lead parameters consists of all patients for whom a value was measured at the specified timepoint.

Outcome measures

Outcome measures
Measure	Amvia Sky Pacemaker or CRT-P Implantation n=45 Participants Patients implanted with an Amvia Sky pacemaker or CRT-P device Amvia Sky pacemaker or CRT-P device: Subjects with an indication for a pacemaker or CRT-P device were implanted with an Amvia Sky device of the Amvia/Solvia pacemaker family according to standard pacemaker implantation procedures. After implantation with an investigational device, the patients were seen by the investigator at pre-hospital discharge, 1-month, 3-months, and 12-months follow-up. All clinical procedures were performed according to clinical routine.
Right Ventricular Sensing Amplitude	10.8 mV Standard Deviation 3.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: The analysis population for right ventricular lead parameters consists of all patients for whom a value was measured at the specified timepoint.

Outcome measures

Outcome measures
Measure	Amvia Sky Pacemaker or CRT-P Implantation n=46 Participants Patients implanted with an Amvia Sky pacemaker or CRT-P device Amvia Sky pacemaker or CRT-P device: Subjects with an indication for a pacemaker or CRT-P device were implanted with an Amvia Sky device of the Amvia/Solvia pacemaker family according to standard pacemaker implantation procedures. After implantation with an investigational device, the patients were seen by the investigator at pre-hospital discharge, 1-month, 3-months, and 12-months follow-up. All clinical procedures were performed according to clinical routine.
Right Ventricular Pacing Threshold	0.9 V Standard Deviation 0.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: The analysis population for left ventricular lead parameters consists of those patients that were implanted with an LV lead, i.e. patients with a triple-chamber device, and for whom a value was measured at the specified timepoint.

Outcome measures

Outcome measures
Measure	Amvia Sky Pacemaker or CRT-P Implantation n=7 Participants Patients implanted with an Amvia Sky pacemaker or CRT-P device Amvia Sky pacemaker or CRT-P device: Subjects with an indication for a pacemaker or CRT-P device were implanted with an Amvia Sky device of the Amvia/Solvia pacemaker family according to standard pacemaker implantation procedures. After implantation with an investigational device, the patients were seen by the investigator at pre-hospital discharge, 1-month, 3-months, and 12-months follow-up. All clinical procedures were performed according to clinical routine.
Left Ventricular Sensing Amplitude	11.5 mV Standard Deviation 6.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Amvia Sky Pacemaker or CRT-P Implantation n=7 Participants Patients implanted with an Amvia Sky pacemaker or CRT-P device Amvia Sky pacemaker or CRT-P device: Subjects with an indication for a pacemaker or CRT-P device were implanted with an Amvia Sky device of the Amvia/Solvia pacemaker family according to standard pacemaker implantation procedures. After implantation with an investigational device, the patients were seen by the investigator at pre-hospital discharge, 1-month, 3-months, and 12-months follow-up. All clinical procedures were performed according to clinical routine.
Left Ventricular Pacing Threshold	1.4 V Standard Deviation 0.5

Adverse Events

Amvia Sky Pacemaker or CRT-P Implantation

Serious events: 30 serious events

Other events: 27 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Amvia Sky Pacemaker or CRT-P Implantation n=52 participants at risk Patients implanted with an Amvia Sky pacemaker or CRT-P device Amvia Sky pacemaker or CRT-P device: Subjects with an indication for a pacemaker or CRT-P device were implanted with an Amvia Sky device of the Amvia/Solvia pacemaker family according to standard pacemaker implantation procedures. After implantation with an investigational device, the patients were seen by the investigator at pre-hospital discharge, 1-month, 3-months, and 12-months follow-up. All clinical procedures were performed according to clinical routine.
Infections and infestations Pneumonia	7.7% 4/52 • Number of events 6 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
General disorders Adverse drug reaction	7.7% 4/52 • Number of events 5 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Cardiac disorders Atrial fibrillation	7.7% 4/52 • Number of events 4 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Injury, poisoning and procedural complications Fall	5.8% 3/52 • Number of events 3 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Injury, poisoning and procedural complications Procedural pneumothorax	5.8% 3/52 • Number of events 3 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Infections and infestations Respiratory tract infection	5.8% 3/52 • Number of events 3 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Infections and infestations Urinary tract infection	5.8% 3/52 • Number of events 3 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Cardiac disorders Cardiac failure	3.8% 2/52 • Number of events 2 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Cardiac disorders Cardiac failure congestive	3.8% 2/52 • Number of events 2 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	3.8% 2/52 • Number of events 2 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Psychiatric disorders Delirium	3.8% 2/52 • Number of events 2 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Vascular disorders Hypotension	3.8% 2/52 • Number of events 2 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Nervous system disorders Cerebrovascular accident	1.9% 1/52 • Number of events 2 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Cardiac disorders Accelerated idioventricular rhythm	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Renal and urinary disorders Acute kidney injury	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Cardiac disorders Acute myocardial infarction	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Reproductive system and breast disorders Adnexa uteri mass	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Blood and lymphatic system disorders Anaemia	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Cardiac disorders Aortic valve incompetence	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Respiratory, thoracic and mediastinal disorders Aspiration	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Respiratory, thoracic and mediastinal disorders Atelectasis	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Cardiac disorders Atrial flutter	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Cardiac disorders Atrial tachycardia	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Musculoskeletal and connective tissue disorders Back pain	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer recurrent	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Infections and infestations Bronchitis	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Infections and infestations Candida infection	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Nervous system disorders Central nervous system lesion	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Nervous system disorders Cerebral ischaemia	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
General disorders Condition aggravated	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Vascular disorders Deep vein thrombosis	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Nervous system disorders Dementia Alzheimer's type	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Nervous system disorders Dizziness	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Skin and subcutaneous tissue disorders Eczema	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Infections and infestations Enterobacter pneumonia	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Infections and infestations Escherichia urinary tract infection	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Metabolism and nutrition disorders Fluid overload	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrooesophageal cancer recurrent	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Nervous system disorders Generalised tonic-clonic seizure	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Eye disorders Glaucoma	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioma	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Psychiatric disorders Hallucination	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Hepatobiliary disorders Hepatic function abnormal	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Infections and infestations Herpes simplex encephalitis	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Infections and infestations Herpes simplex meningoencephalitis	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Skin and subcutaneous tissue disorders Hyperhidrosis	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Gastrointestinal disorders Ileus	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Vascular disorders Iliac artery perforation	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
General disorders Implant site erythema	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
General disorders Implant site pain	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
General disorders Implant site swelling	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
General disorders Implant site warmth	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Investigations Inflammatory marker increased	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Gastrointestinal disorders Intestinal mass	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Product Issues Lead dislodgement	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Nervous system disorders Loss of consciousness	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Respiratory, thoracic and mediastinal disorders Lung consolidation	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Metabolism and nutrition disorders Malnutrition	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Infections and infestations Morganella infection	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Cardiac disorders Myocardial infarction	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Injury, poisoning and procedural complications Nerve injury	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Infections and infestations Oral candidiasis	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Vascular disorders Orthostatic hypotension	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Investigations Oxygen saturation decreased	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Musculoskeletal and connective tissue disorders Pain in extremity	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Skin and subcutaneous tissue disorders Pemphigoid	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
General disorders Peripheral swelling	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Infections and infestations Pneumonia moraxella	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Renal and urinary disorders Polyuria	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Injury, poisoning and procedural complications Procedural complication	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Reproductive system and breast disorders Prostatitis	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Skin and subcutaneous tissue disorders Rash	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Nervous system disorders Somnolence	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Injury, poisoning and procedural complications Spinal compression fracture	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Infections and infestations Tooth infection	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Cardiac disorders Tricuspid valve incompetence	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Infections and infestations Urinary tract infection bacterial	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Infections and infestations Vestibular neuronitis	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.

Other adverse events

Other adverse events
Measure	Amvia Sky Pacemaker or CRT-P Implantation n=52 participants at risk Patients implanted with an Amvia Sky pacemaker or CRT-P device Amvia Sky pacemaker or CRT-P device: Subjects with an indication for a pacemaker or CRT-P device were implanted with an Amvia Sky device of the Amvia/Solvia pacemaker family according to standard pacemaker implantation procedures. After implantation with an investigational device, the patients were seen by the investigator at pre-hospital discharge, 1-month, 3-months, and 12-months follow-up. All clinical procedures were performed according to clinical routine.
Product Issues Device computer issue	9.6% 5/52 • Number of events 8 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
General disorders Adverse drug reaction	5.8% 3/52 • Number of events 4 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Infections and infestations Corona virus infection	5.8% 3/52 • Number of events 3 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Cardiac disorders Angina pectoris	3.8% 2/52 • Number of events 2 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Cardiac disorders Atrial fibrillation	3.8% 2/52 • Number of events 2 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Cardiac disorders Atrial flutter	3.8% 2/52 • Number of events 2 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Product Issues Device stimulation issue	3.8% 2/52 • Number of events 2 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Nervous system disorders Dizziness	3.8% 2/52 • Number of events 2 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Nervous system disorders Headache	3.8% 2/52 • Number of events 2 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Vascular disorders Hypertension	3.8% 2/52 • Number of events 2 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
General disorders Non-cardiac chest pain	3.8% 2/52 • Number of events 2 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Injury, poisoning and procedural complications Fall	1.9% 1/52 • Number of events 2 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Metabolism and nutrition disorders Gout	1.9% 1/52 • Number of events 2 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Cardiac disorders Left ventricular dysfunction	1.9% 1/52 • Number of events 2 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Cardiac disorders Ventricular tachycardia	1.9% 1/52 • Number of events 2 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Gastrointestinal disorders Abdominal pain	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Gastrointestinal disorders Abdominal pain lower	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Blood and lymphatic system disorders Anaemia	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Injury, poisoning and procedural complications Anaemia postoperative	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Injury, poisoning and procedural complications Animal bite	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Cardiac disorders Arrhythmia	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Injury, poisoning and procedural complications Back injury	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Cardiac disorders Bundle branch block left	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Cardiac disorders Cardiac sarcoidosis	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
General disorders Chest discomfort	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
General disorders Chest pain	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Gastrointestinal disorders Constipation	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Injury, poisoning and procedural complications Device programming error	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Gastrointestinal disorders Diarrhoea	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
General disorders Fatigue	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Investigations Gastrointestinal stoma output abnormal	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Vascular disorders Haemorrhage	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Injury, poisoning and procedural complications Head injury	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Injury, poisoning and procedural complications Humerus fracture	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Vascular disorders Hypotension	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
General disorders Implant site haematoma	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
General disorders Implant site pain	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
General disorders Implant site paraesthesia	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
General disorders Implant site swelling	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Nervous system disorders Lethargy	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Investigations Liver function test abnormal	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Gastrointestinal disorders Nausea	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Infections and infestations Oral candidiasis	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Vascular disorders Orthostatic hypotension	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
General disorders Pain	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Musculoskeletal and connective tissue disorders Pain in extremity	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Vascular disorders Peripheral coldness	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Injury, poisoning and procedural complications Procedural pain	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Vascular disorders Raynaud's phenomenon	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Renal and urinary disorders Renal cyst	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Renal and urinary disorders Renal impairment	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Immune system disorders Sarcoidosis	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Infections and infestations Skin candida	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Cardiac disorders Tachycardia	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Nervous system disorders Tension headache	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Injury, poisoning and procedural complications Tongue injury	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Product Issues Undersensing	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Renal and urinary disorders Urinary incontinence	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Ear and labyrinth disorders Vertigo	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.
Gastrointestinal disorders Vomiting	1.9% 1/52 • Number of events 1 • Adverse Events were collected from enrollment until study exit at 12-month follow-up, i.e. for one year.

Additional Information

Director Clinical Project Management

BIOTRONIK SE & Co. KG

Phone: +49 30 68905

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60