A Clinical Evaluation of ST Changes in a Group of Patients Having Ventricular Arrhythmias

NCT01685047 | Completed Results

• 1 other identifier: CR-12-014-ID-HV
• Study Type: observational
• Target: 481
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this investigation is to determine the prevalence of device-recorded ST segment changes occurring before appropriate Implantable Cardiac Defibrillator (ICD) therapies (ATP or Shock) and to define their temporal relationship to ventricular arrhythmias.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease; Ventricular Arrhythmias; ST Segment Changes

Outcome Measures

Primary Outcomes (1)

• Among Patients With an Appropriate ICD Therapy (Shock or ATP) for Ventricular Tachycardia or Fibrillation, the Number of Patients Who Have Characterized ST Segment Changes From Baseline Prior to the Therapy Was Calculated.

  Until the end of follow up period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient is implanted with SJM ICD and has or is at high risk of CAD

You may qualify if:

• The patient is implanted with an St Jude Medical (SJM) ICD with ST Monitoring and ShockGuard™ features (and remote care feature in case Merlin.net will be used)
• The patient, in the opinion of the investigator, will not require ventricular pacing for more than 20% of the time.
• The patient, in the opinion of the investigator, has or is at high risk of Coronary Artery Disease (CAD).
• The patient is ≥ 18 years of age.
• The patient is able to provide written Informed Consent prior to any investigational related procedure.

You may not qualify if:

• The patient has longstanding persistent Atrial Fibrillation (AF) /Atrial Flutter (AFl) or permanent AF/AFl
• The patient has documented complete heart block.
• The patient is known to have uncontrolled ventricular bigeminy or trigeminy (PVCs on regular basis).
• The patient has severe Left Ventricular Hypertrophy resulting in interventricular conduction defect (IVCD).
• The patient has intermittent bundle branch blocks (BBB).
• The patient is unable to comply with the follow up schedule.
• The patient is participating in another investigational device or drug investigation.
• The patient is pregnant or is planning to become pregnant during the duration of the investigation.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Kerckhoff Klinik

Bad Nauheim, D-61231, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Limitations and Caveats

Additional investigation into ST segment changes in advance of VT/VF, including their association to confirmed ischemic events, is warranted.

Results Point of Contact

• Title: Karolien Timmermans
• Organization: St Jude Medical

ktimmermans@sjm.com

0032 497 51 39 21

Study Officials

• Johannes SPERZEL, MD

  Kerckhoff Klinik, Bad Nauheim Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: September 13, 2012
• Study Start: December 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: April 1, 2016
• Last Updated: August 28, 2019
• Results First Posted: January 25, 2019

Record last verified: 2019-07

Locations

DE (1)