Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indicated for a VVI(R) pacemaker |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implanted with a Nanostim leadless pacemaker system | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complication Free-rate | A complication is defined as a serious adverse device effect | 6 months |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years |
| Long Term Freedom From Complications |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Subjects who are at least 18 years old and who are indicated for a VVI(R) pacemaker
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Johannes Sperzel, MD | Kerckhoff Klinick GmbH, Bad Nauheim, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Na Homolce Hospital | Prague | 150 30 | Czechia | |||
| CHRU Albert Michallon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27932427 | Derived | Reddy VY, Miller MA, Knops RE, Neuzil P, Defaye P, Jung W, Doshi R, Castellani M, Strickberger A, Mead RH, Doppalapudi H, Lakkireddy D, Bennett M, Sperzel J. Retrieval of the Leadless Cardiac Pacemaker: A Multicenter Experience. Circ Arrhythm Electrophysiol. 2016 Dec;9(12):e004626. doi: 10.1161/CIRCEP.116.004626. |
Not provided
Not provided
491 participants were enrolled in the study but implant could be attempted in 488/491.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Indicated for a VVI(R) Pacemaker | Implanted with a Nanostim leadless pacemaker system |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 22, 2017 |
Not provided
Not provided
Not provided
Not provided
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. |
| 90 days |
| Grenoble |
| 38043 |
| France |
| Hopital La Timone | Marseille | 13385 | France |
| Nouvelles cliniques Nantaises | Nantes | 44270 | France |
| CHRU Hopital de Pontchaillou | Rennes | 35033 | France |
| CHU Strasbourg - Hôpital de Hautepierre | Strasbourg | 67200 | France |
| Kerckhoff-Klinik gGmbH | Bad Nauheim | 61231 | Germany |
| Universitätsmedizin Berlin - Campus Benjamin Franklin | Berlin | 12200 | Germany |
| Klinikum Bielefeld gGmbH Klinikum-Mitte | Bielefeld | 33604 | Germany |
| Herzzentrum Dresden GmbH Universitätsklinik | Dresden | 01307 | Germany |
| Asklepios Klinik St. Georg | Hamburg | 20099 | Germany |
| Kath. Krankenhaus Marienhospital | Herne | 44625 | Germany |
| Herzzentrum Leipzig GmbH | Leipzig | 04289 | Germany |
| Deutsches Herzzentrum München des Freistaates Bayern | München | 80636 | Germany |
| Kliniken Villingen-Schwenningen | Villingen-Schwenningen | 78052 | Germany |
| Az. Osp. Spedali Civili di Brescia | Brescia | 25124 | Italy |
| Ospedale San Raffaele | Milan | 20132 | Italy |
| Ospedale Niguarda Ca'Granda | Milan | 20132 | Italy |
| Centro Cardiologico Monzino | Milan | 20138 | Italy |
| Policlinico San Donato | San Donato Milanese | 20097 | Italy |
| Azienda Ospedaliera Bolognini | Seriate | 24068 | Italy |
| AMC | Amsterdam | 1105 AZ | Netherlands |
| Isala Klinieken | Zwolle | 8025 | Netherlands |
| Hospital Infanta Cristina | Badajoz | 6080 | Spain |
| Hospital Universitario de la Paz | Madrid | 28046 | Spain |
| Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Universitario Donostia | San Sebastián | 20014 | Spain |
| Hospital do Meixoeiro | Vigo | 36214 | Spain |
| St. Bartholomew's Hospital | London | EC1A 7BE | United Kingdom |
| Royal Brompton Hospital | London | SW3 6NP | United Kingdom |
| Manchester Heart Center, Manchester Royal Infirmary | Manchester | M13 9WL | United Kingdom |
| John Radcliffe Hospital | Oxford | OX3 9DU | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
491 participants were enrolled in the study but implant could be attempted in 488/491. Baseline analyses include all participants enrolled
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Indicated for a VVI(R) Pacemaker | Implanted with a Nanostim leadless pacemaker system |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Body-Mass Index | Values were not taken for 2 patients, it was forgotten by the team. | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||||
| Weight | Value was not taken for 1 patient, it was forgotten by the clinical team. | Mean | Standard Deviation | kg |
| ||||||||||||||||
| Height | Values was not taken by the clinical team | Mean | Standard Deviation | cm |
| ||||||||||||||||
| LV Ejection Fraction | Ejection fraction values could not be taken in 213 participants | Mean | Standard Deviation | Percentage of Left Ventricular Ejection |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complication Free-rate | A complication is defined as a serious adverse device effect | The evaluation was completed for the first 300 subjects that completed 6 months of follow-up. | Posted | Count of Participants | Participants | 6 months |
|
|
| ||||||||||||||||||||||||||||
| 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. | Posted | Number | 95% Confidence Interval | percentage of patients | 5 years |
|
| |||||||||||||||||||||||||||||
| 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. | Posted | Number | 95% Confidence Interval | percentage of patients | 90 days |
|
|
The adverse event were collected over a period of 8 years
The same classification criteria as clinicaltrials.gov were used for seriousness of adverse events. Adverse events are presented based on the term classified by the Sponsor. For some events, the term is the same as the organ system class.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Indicated for a VVI(R) Pacemaker | Implanted with a Nanostim leadless pacemaker system | 140 | 491 | 142 | 491 | 7 | 491 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decompensated HF | Cardiac disorders | Systematic Assessment |
| ||
| Infection, Local at Access Site, Or Systemic | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Stroke | Vascular disorders | Systematic Assessment |
| ||
| Respiratory Disease/Disorder | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac Arrhythmias | Cardiac disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hematoma Formation, Including, Retroperitoneal Hematoma/Hemorrhage | Vascular disorders | Systematic Assessment |
| ||
| Excessive Bleeding | Vascular disorders | Systematic Assessment |
| ||
| Insufficient Cardiac Output | Cardiac disorders | Systematic Assessment |
| ||
| Pericardial Effusion | Cardiac disorders | Systematic Assessment |
| ||
| Syncope | Cardiac disorders | Systematic Assessment |
| ||
| General Disorders | General disorders | Systematic Assessment |
| ||
| Neoplasms, Benign, Malignant and Unspecified Tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Cardiac Disorder | Cardiac disorders | Systematic Assessment |
| ||
| Infections and Infestations | Infections and infestations | Systematic Assessment |
| ||
| Renal and Urinary Disorder | Renal and urinary disorders | Systematic Assessment |
| ||
| Endocrine Disorder | Endocrine disorders | Systematic Assessment |
| ||
| Injury, Poisoning and Procedural Complications | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Vascular disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cardiac Arrhythmias | Cardiac disorders | Systematic Assessment |
| ||
| Palpitations | Cardiac disorders | Systematic Assessment |
| ||
| Investigations | Product Issues | Systematic Assessment | Event described as investigations involved subject exhibiting increased inflammatory markers shortly after the implant procedure. The investigator indicated that the increase may be related to the implant procedure. |
|
The primary safety endpoint was met however, the supplementary endpoint of freedom from complications at 5 years was only evaluated using descriptive analyses. The enrollment goal for a powered analysis was not met since enrollments were suspended on October 28, 2016. The Nanostim LP device was not commercialized in the US and commercial sales in the EU were discontinued in 2016. The device was redesigned into the Aveir VR LP device- evaluated in the LEADLESS II Phase 2 study (NCT04559945.)
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicole Harbert | Abbott Medical | 1-972-526-4841 | nicole.harbert@abbott.com |
| Nov 7, 2023 |
| Prot_SAP_000.pdf |
|
| Italy |
|
|
| United Kingdom |
|
|
| France |
|
|
| Germany |
|
|
| Spain |
|
|
| Title | Denominators | Categories |
|---|
|
| Title | Denominators | Categories |
|---|
|