Trial Outcomes & Findings for The LEADLESS Observational Study (NCT NCT02051972)

NCT ID: NCT02051972

Last Updated: 2025-06-06

Results Overview

A complication is defined as a serious adverse device effect

Recruitment status

COMPLETED

Target enrollment

491 participants

Primary outcome timeframe

6 months

Results posted on

2025-06-06

Participant Flow

491 participants were enrolled in the study but implant could be attempted in 488/491.

Participant milestones

Participant milestones
Measure	Indicated for a VVI(R) Pacemaker Implanted with a Nanostim leadless pacemaker system
Overall Study STARTED	488
Overall Study COMPLETED	139
Overall Study NOT COMPLETED	349

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Indicated for a VVI(R) Pacemaker n=491 Participants Implanted with a Nanostim leadless pacemaker system
Age, Continuous	75.8 years STANDARD_DEVIATION 12.9 • n=491 Participants
Sex: Female, Male Female	182 Participants n=491 Participants
Sex: Female, Male Male	309 Participants n=491 Participants
Region of Enrollment Netherlands	86 participants n=491 Participants
Region of Enrollment Czechia	99 participants n=491 Participants
Region of Enrollment Italy	47 participants n=491 Participants
Region of Enrollment United Kingdom	20 participants n=491 Participants
Region of Enrollment France	107 participants n=491 Participants
Region of Enrollment Germany	66 participants n=491 Participants
Region of Enrollment Spain	66 participants n=491 Participants
Body-Mass Index	27.3 kg/m^2 STANDARD_DEVIATION 6.6 • n=489 Participants • Values were not taken for 2 patients, it was forgotten by the team.
Weight	78.9 kg STANDARD_DEVIATION 20.9 • n=490 Participants • Value was not taken for 1 patient, it was forgotten by the clinical team.
Height	169.8 cm STANDARD_DEVIATION 9.3 • n=489 Participants • Values was not taken by the clinical team
LV Ejection Fraction	57.8 Percentage of Left Ventricular Ejection STANDARD_DEVIATION 9.2 • n=278 Participants • Ejection fraction values could not be taken in 213 participants

PRIMARY outcome

Timeframe: 6 months

Population: The evaluation was completed for the first 300 subjects that completed 6 months of follow-up.

A complication is defined as a serious adverse device effect

Outcome measures

Outcome measures
Measure	Indicated for a VVI(R) Pacemaker n=300 Participants Implanted with a Nanostim leadless pacemaker system
Complication Free-rate Number of patients with SADEs	16 Participants
Complication Free-rate Number of patients free of SADEs	284 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Indicated for a VVI(R) Pacemaker n=488 Participants Implanted with a Nanostim leadless pacemaker system
Long Term Freedom From Complications	55.9 percentage of patients Interval 50.3 to 61.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days

Outcome measures

Outcome measures
Measure	Indicated for a VVI(R) Pacemaker n=488 Participants Implanted with a Nanostim leadless pacemaker system
Long Term Freedom From Complications	94.0 percentage of patients Interval 91.5 to 95.8

Adverse Events

Indicated for a VVI(R) Pacemaker

Serious events: 142 serious events

Other events: 7 other events

Deaths: 140 deaths

Serious adverse events

Serious adverse events
Measure	Indicated for a VVI(R) Pacemaker n=491 participants at risk Implanted with a Nanostim leadless pacemaker system
Cardiac disorders Decompensated HF	3.9% 19/491 • Number of events 20 • 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.
Skin and subcutaneous tissue disorders Infection, Local at Access Site, Or Systemic	4.1% 20/491 • Number of events 20 • 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.
Vascular disorders Stroke	2.2% 11/491 • Number of events 11 • 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.
Respiratory, thoracic and mediastinal disorders Respiratory Disease/Disorder	1.6% 8/491 • Number of events 8 • 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.
Cardiac disorders Myocardial Infarction	1.0% 5/491 • Number of events 5 • 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.
Cardiac disorders Cardiac Arrhythmias	0.81% 4/491 • Number of events 4 • 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.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.41% 2/491 • Number of events 2 • 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.
Vascular disorders Hematoma Formation, Including, Retroperitoneal Hematoma/Hemorrhage	0.41% 2/491 • Number of events 2 • 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.
Vascular disorders Excessive Bleeding	0.20% 1/491 • Number of events 1 • 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.
Cardiac disorders Insufficient Cardiac Output	0.20% 1/491 • Number of events 1 • 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.
Cardiac disorders Pericardial Effusion	0.20% 1/491 • Number of events 1 • 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.
Cardiac disorders Syncope	0.20% 1/491 • Number of events 1 • 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.
General disorders General Disorders	5.9% 29/491 • Number of events 29 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms, Benign, Malignant and Unspecified Tumor	4.9% 24/491 • Number of events 24 • 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.
Cardiac disorders Cardiac Disorder	1.6% 8/491 • Number of events 8 • 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.
Infections and infestations Infections and Infestations	0.81% 4/491 • Number of events 4 • 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.
Renal and urinary disorders Renal and Urinary Disorder	0.81% 4/491 • Number of events 4 • 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.
Endocrine disorders Endocrine Disorder	0.20% 1/491 • Number of events 1 • 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.
Injury, poisoning and procedural complications Injury, Poisoning and Procedural Complications	0.20% 1/491 • Number of events 1 • 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.

Other adverse events

Other adverse events
Measure	Indicated for a VVI(R) Pacemaker n=491 participants at risk Implanted with a Nanostim leadless pacemaker system
Vascular disorders Dizziness	0.41% 2/491 • Number of events 2 • 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.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.41% 2/491 • Number of events 2 • 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.
Cardiac disorders Cardiac Arrhythmias	0.20% 1/491 • Number of events 1 • 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.
Cardiac disorders Palpitations	0.20% 1/491 • Number of events 1 • 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.
Product Issues Investigations	0.20% 1/491 • Number of events 1 • 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.

Additional Information

Nicole Harbert

Abbott Medical

Phone: 1-972-526-4841

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place