NCT02814214

Brief Summary

The purpose of this study is to collect simultaneous surface electrocardiogram (ECG) recordings and Cardiac Resynchronization Therapy (CRT) intracardiac electrogram (IEGM) recordings of variations in electrical synchrony.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 27, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2019

Enrollment Period

1.2 years

First QC Date

June 22, 2016

Last Update Submit

January 31, 2019

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Characterize CRT IEGM-based estimations of QRS duration

    Acute (1 day)

Study Arms (1)

ECG+IEGM

Surface ECG and intracardiac electrogram recordings will be taken during the adjustment of programmable Cardiac Resynchronization Therapy settings

Device: ECG+IEGM

Interventions

ECG+IEGMDEVICE

Cardiac Resynchronization Therapy programming adjustments

ECG+IEGM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will include approximately 100 patients who have been implanted with SJM Quadripolar Pacing Systems

You may qualify if:

  • Already implanted with SJM Quadripolar CRT Pacing System
  • Ability to provide informed consent for study participation
  • Willing to comply with the study evaluation requirements
  • At least 18 years of age

You may not qualify if:

  • Resting ventricular rate \>100 bpm
  • Intrinsic PR interval \> 300 ms
  • Paroxysmal or persistent atrial tachycardia or atrial fibrillation documented
  • Pregnant or plans to become pregnant during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

I.R.C.C.S. Policlinico San Donato

San Donato Milanese, MI, 20097, Italy

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

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

Study Record Dates

First Submitted

June 22, 2016

First Posted

June 27, 2016

Study Start

June 1, 2016

Primary Completion

August 1, 2017

Study Completion

September 1, 2017

Last Updated

February 4, 2019

Record last verified: 2019-01

Locations

IT(1)