Trial Outcomes & Findings for REASSURE AV Registry (NCT NCT01074034)

Last Updated: 2017-08-01

Results Overview

Incidences of ventricular shock therapy up to three months post implant. Rescue shocks are intended for the treatment of cardiac arrhythmias detected in the ventricle at rates greater than 220 bpm, including arrhythmias that originate in the atria if they are conducted at rates greater than 220 bpm as this can be life threatening if persistent. Shocks delivered for other reasons will be considered inappropriate shocks.

Recruitment status

COMPLETED

Study phase

Target enrollment

211 participants

Primary outcome timeframe

Three months post-implant

Results posted on

2017-08-01

Participant Flow

Participant milestones

Participant milestones
Measure	B301 Device B301 ASSURE Device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device
Overall Study STARTED	211
Overall Study COMPLETED	205
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

REASSURE AV Registry

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AV Therapy Assessment Group n=211 Participants AV Therapy Assessment group, Atrial ATP and Atrial Therapy Suite (ATS) AV Therapy Assessment-B301 investigational device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device Ventricular tachyarrhythmia rescue shock feature AV Therapy Assessment-B301 investigational device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device
Age, Continuous	71.7 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	87 Participants n=5 Participants
Sex: Female, Male Male	124 Participants n=5 Participants
Region of Enrollment United States	211 Participants n=5 Participants

PRIMARY outcome

Timeframe: Three months post-implant

Outcome measures

Outcome measures
Measure	AV Therapy Assessment Group n=211 Participants appropriate system performance of the atrial and ventricular tachyarrhythmia therapies in the ASSURE device AV Therapy Assessment-B301 investigational device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device
Inappropriate Shock Free Rate	97.2 % of shock free rates

SECONDARY outcome

Timeframe: Three months post-implant

For a pacemaker patient who experiences a spontaneous high rate ventricular arrhythmia, the ASSURE device may provide rescue shocks, a faster and more effective response than external methods of rescue. Successful conversion of an episode is defined by conversion to either; sinus rhythm, sinus tachycardia or atrial pacing by one minute post therapy delivery.

Outcome measures

Outcome measures
Measure	AV Therapy Assessment Group n=22 Participants appropriate system performance of the atrial and ventricular tachyarrhythmia therapies in the ASSURE device AV Therapy Assessment-B301 investigational device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device
Conversion Success Rate up to Three Months Post-implant	90.9 % of conversion rates

Adverse Events

B301 Device

Serious events: 52 serious events

Other events: 17 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	B301 Device n=211 participants at risk B301 ASSURE Device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device
General disorders Adverse reaction - General	0.95% 2/211 • Number of events 2 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Blood and lymphatic system disorders Aortic stenosis	0.95% 2/211 • Number of events 2 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Cardiac disorders Atrial fibrillation	2.4% 5/211 • Number of events 6 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Nervous system disorders Cerebrovascular accident	0.95% 2/211 • Number of events 2 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Cardiac disorders Coronary artery disease	0.95% 2/211 • Number of events 2 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Blood and lymphatic system disorders Deep vein thrombosis	0.47% 1/211 • Number of events 1 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
General disorders Dehydration	0.47% 1/211 • Number of events 1 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Cardiac disorders Dislodgment - Elevated threshold - RV	0.47% 1/211 • Number of events 1 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Cardiac disorders Dislodgment - Unable to capture - RA	0.95% 2/211 • Number of events 2 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea - Heart failure	0.95% 2/211 • Number of events 2 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Cardiac disorders Early ERI - Random component failure	0.47% 1/211 • Number of events 1 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Endocrine disorders Endocrine	0.95% 2/211 • Number of events 2 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Cardiac disorders Extracardiac stimulation - RV	0.47% 1/211 • Number of events 1 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Reproductive system and breast disorders Genitourinary	2.4% 5/211 • Number of events 5 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Skin and subcutaneous tissue disorders Guidewire removal- femoral vein	0.47% 1/211 • Number of events 1 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Eye disorders Head, eyes, ears, nose, throat (HEENT)	0.47% 1/211 • Number of events 1 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Blood and lymphatic system disorders Hematological	0.47% 1/211 • Number of events 1 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Blood and lymphatic system disorders Hematoma - Pocket (<=30 days post-implant)	0.47% 1/211 • Number of events 1 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Blood and lymphatic system disorders Hypotension	0.47% 1/211 • Number of events 1 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Cardiac disorders Inappropriate tachy therapy - SVT	0.47% 1/211 • Number of events 1 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Skin and subcutaneous tissue disorders Integumentary	0.95% 2/211 • Number of events 2 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Cardiac disorders Intermittent claudication	0.47% 1/211 • Number of events 1 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
General disorders Latching	0.95% 2/211 • Number of events 2 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
General disorders Migration	0.47% 1/211 • Number of events 1 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Cardiac disorders Multiple heart failure symptoms	3.3% 7/211 • Number of events 7 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
General disorders Multiple symptoms	0.95% 2/211 • Number of events 2 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Cardiac disorders Multi-system failure - Heart failure	0.47% 1/211 • Number of events 1 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal	1.4% 3/211 • Number of events 3 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Cardiac disorders Myocardial infarction	0.47% 1/211 • Number of events 1 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Cardiac disorders Pericardial effusion	0.47% 1/211 • Number of events 1 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Cardiac disorders Peripheral edema - Heart failure	0.95% 2/211 • Number of events 2 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary	0.47% 1/211 • Number of events 1 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary edema - Heart failure	0.47% 1/211 • Number of events 1 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.95% 2/211 • Number of events 2 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Cardiac disorders Pulseless electrical activity	0.47% 1/211 • Number of events 1 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Renal and urinary disorders Renal insufficiency - Heart failure	0.47% 1/211 • Number of events 1 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Blood and lymphatic system disorders Seroma - Pocket (<=30 days post-implant)	0.47% 1/211 • Number of events 1 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Cardiac disorders Syncope	0.47% 1/211 • Number of events 1 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.

Other adverse events

Other adverse events
Measure	B301 Device n=211 participants at risk B301 ASSURE Device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device
Cardiac disorders Atrial fibrillation	8.1% 17/211 • Number of events 24 • Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit). An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.

Additional Information

Elke Sommerijns

Boston Scientific

Phone: +32 479 76 71 56

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER