Trial Outcomes & Findings for Safety and Efficacy Study of Tendril MRI™ Leads in Standard Bradycardia Pacing Indication (NCT NCT01528150)

Last Updated: 2019-02-04

Results Overview

Safety of the Accent MRI™ system with the Tendril MRI™ lead will be evaluated in terms of freedom from Right Atrial (RA) and Right Ventricular (RV) lead-related complications for the acute (implant to 2 month visit) and chronic (2 month visit through the 12 month visit) timeframes.

Recruitment status

COMPLETED

Target enrollment

466 participants

Primary outcome timeframe

up to 12 months post-implant

Results posted on

2019-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	Accent MRI System Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads
Overall Study STARTED	466
Overall Study COMPLETED	422
Overall Study NOT COMPLETED	44

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy Study of Tendril MRI™ Leads in Standard Bradycardia Pacing Indication

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Accent MRI System n=466 Participants Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads
Age, Continuous	71.74 years STANDARD_DEVIATION 11.71 • n=5 Participants
Sex: Female, Male Female	194 Participants n=5 Participants
Sex: Female, Male Male	272 Participants n=5 Participants
AtrioVentricular-Block (AV-Block) No AV Block	179 participants n=5 Participants
AtrioVentricular-Block (AV-Block) 1st Degree AV Block	41 participants n=5 Participants
AtrioVentricular-Block (AV-Block) 2nd Degree AV Block	99 participants n=5 Participants
AtrioVentricular-Block (AV-Block) 3rd Degree AV block	147 participants n=5 Participants
Sick Node Dysfunction Sick Node Dysfunction	205 participants n=5 Participants
Sick Node Dysfunction No Sick Node Dysfunction	261 participants n=5 Participants
Neurocardiogenic Syncope Previous Neurocardiogenic Syncope	75 participants n=5 Participants
Neurocardiogenic Syncope No Previous Neurocardiogenic Syncope	391 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 12 months post-implant

Population: A total of 464 patients were implanted. 463 patients (99.78%) were implanted with Accent MRI™ systems with the Tendril MRI™ leads while the remaining 1 patient (0.22%) was implanted with a device that was not an Accent MRI™ system. This patient was excluded from all primary endpoint analyses.

Outcome measures

Outcome measures
Measure	Accent MRI System n=463 Participants Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads
Freedom From RA and RV Lead-related Complications Acute Timeframe (Implant to 2 Months)	97.19 percentage of participants Interval 94.94 to 98.63
Freedom From RA and RV Lead-related Complications Chronic Timeframe (>2 Months to 12 Months)	99.14 percentage of participants Interval 97.58 to 99.81

Adverse Events

Accent MRI System

Serious events: 174 serious events

Other events: 78 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Accent MRI System n=466 participants at risk Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads
Cardiac disorders Arrhythmia	5.4% 25/466 • Number of events 25 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Vascular disorders Cardiac/Venous Perforation	0.43% 2/466 • Number of events 2 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Surgical and medical procedures Device migration	0.21% 1/466 • Number of events 1 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Endocrine disorders Exacerbation of Diabetes	0.43% 2/466 • Number of events 2 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Cardiac disorders Exacerbation of heart failure	3.2% 15/466 • Number of events 15 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Surgical and medical procedures Helix issue	0.21% 1/466 • Number of events 1 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Injury, poisoning and procedural complications hematoma/bleeding	1.1% 5/466 • Number of events 5 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Surgical and medical procedures Impedance out of range	0.21% 1/466 • Number of events 1 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Infections and infestations infection	4.3% 20/466 • Number of events 20 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Surgical and medical procedures lead dislodgement or migration	2.6% 12/466 • Number of events 12 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Musculoskeletal and connective tissue disorders Muskuloskeletal event	2.1% 10/466 • Number of events 10 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Surgical and medical procedures Lead replacement	0.21% 1/466 • Number of events 1 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) neoplastic disease	1.1% 5/466 • Number of events 5 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Nervous system disorders neurological event	3.4% 16/466 • Number of events 16 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Investigations other various	3.4% 16/466 • Number of events 16 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Cardiac disorders Other Cardiac/cardiovascular	5.6% 26/466 • Number of events 26 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Surgical and medical procedures Other lead related	0.21% 1/466 • Number of events 1 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Respiratory, thoracic and mediastinal disorders Pneumothorax/hemothorax	0.64% 3/466 • Number of events 3 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Respiratory, thoracic and mediastinal disorders Pulmonary events	1.9% 9/466 • Number of events 9 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Renal and urinary disorders renal event	0.64% 3/466 • Number of events 3 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.

Other adverse events

Other adverse events
Measure	Accent MRI System n=466 participants at risk Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads
Cardiac disorders arrhythmia	5.8% 27/466 • Number of events 27 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Investigations Decreased right ventricular sensing	0.21% 1/466 • Number of events 1 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Investigations device programming	0.43% 2/466 • Number of events 2 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Cardiac disorders exacerbation of heart failure	0.86% 4/466 • Number of events 4 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Injury, poisoning and procedural complications hematoma/bleeding	0.86% 4/466 • Number of events 4 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Investigations impedance out of range	0.43% 2/466 • Number of events 2 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Infections and infestations infection	0.43% 2/466 • Number of events 2 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Investigations lead noise	0.64% 3/466 • Number of events 3 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Musculoskeletal and connective tissue disorders musculoskeletal event	0.64% 3/466 • Number of events 3 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Nervous system disorders neurological event	0.64% 3/466 • Number of events 3 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Investigations other various	2.8% 13/466 • Number of events 13 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Cardiac disorders other cardio/cardiovascular	1.9% 9/466 • Number of events 9 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Investigations Other lead related	0.21% 1/466 • Number of events 1 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Investigations Pacemaker software issue	0.21% 1/466 • Number of events 1 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Respiratory, thoracic and mediastinal disorders pulmonary event	0.64% 3/466 • Number of events 3 • Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.

Additional Information

Director Clinical Studies

St. Jude Medical

Phone: +1 818 493 3648

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60