NCT01030705

Brief Summary

This study will collect data on features for future pacemakers via an external non-implantable system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2009

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

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

November 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

September 29, 2011

Status Verified

September 1, 2011

Enrollment Period

7 months

First QC Date

December 9, 2009

Last Update Submit

September 28, 2011

Conditions

BradycardiaChronotropic Incompetence

Keywords

Bradycardiapacemaker

Eligibility Criteria

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

Primary care clinic patients

You may qualify if:

  • Patients who are scheduled to receive either Pacemaker (dual chamber) or CRT-P devices based on physician discretion
  • Patients who are willing and capable of participating in all testing associated with this Clinical Investigation
  • Patients who are age 18 or above, or of legal age to give informed consent specific to state and national law

You may not qualify if:

  • Patient enrolled in any concurrent study, without Boston Scientific CRM written approval, that may confound the results of this study
  • Patients with a prosthetic mechanical tricuspid heart valve
  • Women who are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

St. Luke's Hospital

Cedar Rapids, Iowa, 52043, United States

Location

Nebraska Heart Institute

Lincoln, Nebraska, 68526, United States

Location

University of Pittsburgh Medical Center, Cardiac Electrophysiology

Pittsburgh, Pennsylvania, 15213, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

Virginia Commonwealth University Health System, Medical College of Virginia, MCV Physicians and Hospitals

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Samir Saba, MD

    Health Care Conusltant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2009

First Posted

December 11, 2009

Study Start

November 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

September 29, 2011

Record last verified: 2011-09

Locations

US(5)