Optimal EGM Configuration for Morphology Discrimination

Premature Ventricular Complexes Clinical Trial

— SVT Morphology  

Official title:

Optimal EGM Configuration for Morphology Discrimination

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00888667
• Other study ID #: HV001
• Status: Terminated
• Start date: April 2009
• Est. completion date: May 2010

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study will be a prospective cohort study of 20 patients recruited from site's Defibrillator Clinic patient population who are followed at the site.

Hypothesis: Among the available EGM configuration options, one is better than the others for detection enhancements purposes.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients must already have an implanted St. Jude Medical dual chamber ICD with a dual coil defibrillator lead.

2. Patients must be willing to sign an informed consent form.

3. Patients must have frequent PVCs (minimum of 30/hour)

Exclusion Criteria:

1. Known history of slow VT (under 160 bpm).

2. Patients under the age of 18 years.

3. Pregnant women.

4. Pacemaker dependent rhythm.

5. Ongoing angina pectoris.

6. Current NYHA Class 3-4 heart failure.

Related Conditions & MeSH terms

• Premature Ventricular Complexes
• Ventricular Premature Complexes

Intervention

Other:
• Pacing interventions
10 seconds recording of atrial paced rhythm at 100 ppm in sitting 10 seconds recording of atrial paced rhythm at 150 ppm in supine 10 seconds recording of atrial paced rhythm at 150 ppm in sitting

Locations

Country	Name	City	State
Canada	St Michael's Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Abbott Medical Devices	St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% morphology match	off line analysis	acute