Indications for VVI(R) Pacemaker
Conditions
Brief summary
The objective of the study is to confirm clinical performance and safety of the Nanostim leadless cardiac pacemaker system within its intended use and according to its instructions for use.
Interventions
DEVICEImplanted with a Nanostim leadless pacemaker system
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject must have one of the following clinical indications: Chronic atrial fibrillation with 2 or 3° AV or bifascicular bundle branch block (BBB block) ; or Normal sinus rhythm with 2º or 3° AV or BBB block and a low level of physical activity or short expected lifespan (but at least one year); or Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings; and * Subject ≥18 years of age; and * Subject has life expectancy of at least one year and is a suitable candidate based on overall health and well-being; and * Subject is not enrolled in another clinical investigation with a treatment arm or that could confound the results of this study; and * Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and * Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the EC; and * Subject is not pregnant and does not plan on getting pregnant during the course of the study.
Exclusion criteria
* Known pacemaker syndrome, have retrograde VA conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing; or * Hypersensitivity to \< 1 mg of dexamethasone sodium phosphate; or * Mechanical tricuspid valve prosthesis; or * Pre-existing pulmonary arterial (PA) hypertension (PA systolic pressure exceeds 40mmHg or RV systolic pressure (RVSP) as estimated by echo exceeds 40mmHg) or significant physiologically-impairing lung disease (has severe pulmonary disease producing frequent hospitalization for respiratory distress or requiring continuous home oxygen); or * Pre-existing ventricular pacing or defibrillation leads; or * Current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT); or * Presence of implanted vena cava filter; or * Evidence of thrombosis in one of the veins used for access during the procedure; or * Cardiovascular or peripheral vascular surgery/intervention within 30 days of enrolment; or * Presence of implanted leadless cardiac pacemaker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complication Free-rate | 6 months | A complication is defined as a serious adverse device effect |
Other
| Measure | Time frame | Description |
|---|---|---|
| Long Term Freedom From Complications | 5 years | A complication is defined as a serious adverse device effect. The complication-free rate was calculated using the Kaplan-Meier method, and the 95% confidence interval was estimated using the Greenwood method. |
Countries
Czechia, France, Germany, Italy, Netherlands, Spain, United Kingdom
Participant flow
Pre-assignment details
491 participants were enrolled in the study but implant could be attempted in 488/491.
Participants by arm
| Arm | Count |
|---|---|
| Indicated for a VVI(R) Pacemaker Implanted with a Nanostim leadless pacemaker system | 491 |
| Total | 491 |
Baseline characteristics
| Characteristic | Indicated for a VVI(R) Pacemaker | — |
|---|---|---|
| Age, Continuous | 75.8 years STANDARD_DEVIATION 12.9 | — |
| Body-Mass Index | 27.3 kg/m^2 STANDARD_DEVIATION 6.6 | — |
| Height | 169.8 cm STANDARD_DEVIATION 9.3 | — |
| LV Ejection Fraction | 57.8 Percentage of Left Ventricular Ejection STANDARD_DEVIATION 9.2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Czechia | 99 participants | — |
| Region of Enrollment France | 107 participants | — |
| Region of Enrollment Germany | 66 participants | — |
| Region of Enrollment Italy | 47 participants | — |
| Region of Enrollment Netherlands | 86 participants | — |
| Region of Enrollment Spain | 66 participants | — |
| Region of Enrollment United Kingdom | 20 participants | — |
| Sex: Female, Male Female | 182 Participants | — |
| Sex: Female, Male Male | 309 Participants | — |
| Weight | 78.9 kg STANDARD_DEVIATION 20.9 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 140 / 491 |
| other Total, other adverse events | 7 / 491 |
| serious Total, serious adverse events | 142 / 491 |
Outcome results
Primary
Complication Free-rate
A complication is defined as a serious adverse device effect
Time frame: 6 months
Population: The evaluation was completed for the first 300 subjects that completed 6 months of follow-up.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Indicated for a VVI(R) Pacemaker | Complication Free-rate | Number of patients with SADEs | 16 Participants |
| Indicated for a VVI(R) Pacemaker | Complication Free-rate | Number of patients free of SADEs | 284 Participants |
Other Pre-specified
Long Term Freedom From Complications
A complication is defined as a serious adverse device effect. The complication-free rate was calculated using the Kaplan-Meier method, and the 95% confidence interval was estimated using the Greenwood method.
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Indicated for a VVI(R) Pacemaker | Long Term Freedom From Complications | 55.9 percentage of patients |
Other Pre-specified
Long Term Freedom From Complications
A complication is defined as a serious adverse device effect. The complication-free rate was calculated using the Kaplan-Meier method, and the 95% confidence interval was estimated using the Greenwood method.
Time frame: 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Indicated for a VVI(R) Pacemaker | Long Term Freedom From Complications | 94.0 percentage of patients |