Trial Outcomes & Findings for Acute Defibrillation Study (NCT NCT02227121)

NCT ID: NCT02227121

Last Updated: 2017-02-13

Results Overview

Subjects will demonstrate a successful defibrillation outcome if they have a successful defibrillation shock with the research system.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 16 participants
• Primary outcome timeframe: Day of procedure
• Results posted on: 2017-02-13

Participant Flow

Participant milestones

Measure	Enrolled Subjects All subjects consented for the study.
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acute Defibrillation Study

Baseline characteristics by cohort

Measure	Enrolled Subjects n=16 Participants All subjects consented for the study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Age, Continuous	61.6 years n=5 Participants
Gender Female	4 Participants n=5 Participants
Gender Male	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United Kingdom · Hong Kong	7 Participants n=5 Participants
Region of Enrollment United Kingdom · United Kingdom	5 Participants n=5 Participants
Region of Enrollment United Kingdom · Poland	3 Participants n=5 Participants
Region of Enrollment United Kingdom · Netherlands	1 Participants n=5 Participants
Primary Indication for Surgery Cardiac Surgery: Coronary Artery Bypass Graft	2 Participants n=5 Participants
Primary Indication for Surgery Cardiac Surgery: Valve Replacement	5 Participants n=5 Participants
Primary Indication for Surgery Cardiac Surgery: Valve Repair	2 Participants n=5 Participants
Primary Indication for Surgery Surgery Related to ICD (transvenous)	1 Participants n=5 Participants
Primary Indication for Surgery Surgery Related to S-ICD (subcutaneous ICD)	5 Participants n=5 Participants
Primary Indication for Surgery Aortic Aneurysm	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day of procedure

Population: Only subjects with ventricular fibrillation successfully induced were eligible for analysis

Subjects will demonstrate a successful defibrillation outcome if they have a successful defibrillation shock with the research system.

Outcome measures

Measure	VF Induction and Defibrillation n=14 Participants Ventricular Fibrillation (VF) induction and defibrillation will be carried out as the invention in all subjects undergoing study procedures. Defibrillation following induction of VF: Up to 10 VF induction attempts followed by shock(s) delivered by an externally placed Implantable Cardioverter/Defibrillator (ICD) and/or external defibrillator.
Defibrillation Outcome VF Successfully Terminated with 35J shock	13 Participants
Defibrillation Outcome VF Not Successfully Terminated with 35J shock	1 Participants

Adverse Events

Enrolled Subjects

Serious events: 5 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Enrolled Subjects n=16 participants at risk All subjects consented into the study
Infections and infestations Clostridium difficile colitis	6.2% 1/16 • Number of events 1 • Baseline Assessment to routine Post-surgery follow-up visit.
Cardiac disorders Atrioventricular block complete	6.2% 1/16 • Number of events 1 • Baseline Assessment to routine Post-surgery follow-up visit.
Gastrointestinal disorders Gastrointestinal haemorrhage	6.2% 1/16 • Number of events 1 • Baseline Assessment to routine Post-surgery follow-up visit.
Injury, poisoning and procedural complications Contusion	6.2% 1/16 • Number of events 1 • Baseline Assessment to routine Post-surgery follow-up visit.
Cardiac disorders Chest pain	6.2% 1/16 • Number of events 1 • Baseline Assessment to routine Post-surgery follow-up visit.

Other adverse events

Measure	Enrolled Subjects n=16 participants at risk All subjects consented into the study
Respiratory, thoracic and mediastinal disorders Lower respiratory tract infection	6.2% 1/16 • Number of events 1 • Baseline Assessment to routine Post-surgery follow-up visit.
Metabolism and nutrition disorders Hypokalaemia	6.2% 1/16 • Number of events 1 • Baseline Assessment to routine Post-surgery follow-up visit.
Cardiac disorders Pericardial effusion	6.2% 1/16 • Number of events 1 • Baseline Assessment to routine Post-surgery follow-up visit.
Skin and subcutaneous tissue disorders Erythema	6.2% 1/16 • Number of events 1 • Baseline Assessment to routine Post-surgery follow-up visit.
General disorders Post-traumatic headache	6.2% 1/16 • Number of events 1 • Baseline Assessment to routine Post-surgery follow-up visit.

Additional Information

Griet Wouters

Medtronic Cardiac Rhythm and Heart Failure

Phone: 800-328-2518

Email: MedtronicCRMtrials@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee Generally, contracts allow investigators to publish study results per the protocol and publication plan. Investigators and Participating Institutions will provide any publication of Study Data generated by PI and/or Participating Institution to Medtronic for review prior to submission to determine if confidential information ("CI") is included and to check for technical correctness. Medtronic may not censor/interfere with the publication beyond the extent necessary to protect CI.
• Publication restrictions are in place

Restriction type: OTHER