Scandinavian Multicenter Study to Advance Risk Stratification in Heart Disease- Ventricular Arrhythmias

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02864771
• Date of registration: 01/07/2016
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Akershus
• Public title: Scandinavian Multicenter Study to Advance Risk Stratification in Heart Disease- Ventricular Arrhythmias SMASH 1
• Scientific title: Scandinavian Multicenter Study to Advance Risk Stratification in Heart Disease- Ventricular Arrhythmias: A Multicenter, Observational Trial
• Date of first enrolment: August 2016
• Target sample size: 504
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02864771
• Study type: Observational

Countries of recruitment

Norway

Contacts

• Name: Torbjørn Omland, MD,PhD, MPH
• Affiliation: Professor of Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients = 18 years old

- Current treatment with an ICD

- Signed written informed consent before study commencement

Exclusion Criteria:

- Participation in other interventional clinical trial or previously included in the
current study

- Patients not able to provide written informed consent

- Known or suspected, non-curable cancer,

- Neurological condition with short life expectancy; e.g. amyotropic lateral sclerosis
(ALS)

- Patients unwilling or unable to comply with the protocol

- History of non-compliance to medical management and patients who are considered
potentially unreliable by the Investigator

- History or evidence of alcohol or drug abuse with the last 12 months that may
influence the participation of the patient in the study, as assessed by the
Investigator during the screening phase

- Any surgical or medical condition, which in the option of the Investigator, will
impair the ability of the patient to participate in the study



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Implantable Defibrillator User

Ventricular Arrhythmias

Heart Disease

Biological Markers

Primary Outcome(s)

Episodes of ventricular fibrillation (VF) or ventricular tachycardia (VT) resulting in appropriately delivered ICD therapies (including antitachycardia pacing) or sustained ventricular tachyarrhythmia (>100/min, >30sek). [Time Frame: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.]

Secondary Outcome(s)

All-cause mortality [Time Frame: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.]

Episodes of ventricular- or supra-ventricular arrhythmias (specified above) registered from the monitoring function of the ICD. [Time Frame: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.]

The combination of cardiovascular mortality and heart failure hospitalizations [Time Frame: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.]

New occurrence of supra-ventricular arrhythmias (i.e. atrial fibrillation, atrial flutter, atrial tachycardia etc.) [Time Frame: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.]

Heart failure hospitalization [Time Frame: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.]

Cardiovascular mortality [Time Frame: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.]

Major adverse cardiac event (MACE), i.e. acute myocardial infarction, stroke, urgent myocardial revascularization and cardiovascular mortality [Time Frame: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.]

Number of premature ventricular complexes (PVCs) and non-sustained VT (> 3 coupled PVCs) registered from the monitoring function of the ICD [Time Frame: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.]

Secondary ID(s)

2015/2080

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Helse Stavanger HF

University of Oslo