Reverse Electrical Remodeling of Native Conduction in Cardiac Resynchronization Therapy (RER CRT)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Larisa Tereshchenko, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01924221
First received: August 14, 2013
Last updated: NA
Last verified: August 2013
History: No changes posted

August 14, 2013
August 14, 2013
December 2011
December 2021   (final data collection date for primary outcome measure)
Sustained ventricular tachyarrhythmias [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Heart Failure Hospitalizations [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Same as current
All-cause mortality [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Same as current
 
Reverse Electrical Remodeling of Native Conduction in Cardiac Resynchronization Therapy
Study of Reverse Electrical Remodeling of Native Conduction in Cardiac Resynchronization Therapy

Cardiac resynchronization therapy with pacemaker alone, or in combination with a cardioverter-defibrillator, prolongs life and decreases risk of heart failure exacerbation in patients with low ejection fraction and wide QRS. Some patients achieve decrease in QRS duration 6 months after cardiac resynchronization therapy. Such fenomenon is called reverse electrical remodeling of native conduction. Retrospective analysis showed that reverse electrical remodeling of the native conduction after at least 6 months of CRT is associated with decreased rate of ventricular arrhythmias and better survival. This study is designed to study reverse electrical remodeling prospectively.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Heart Failure Patients with currently approved indications for implantation of cardiac resynchronization therapy defibrillator

  • Heart Failure.
  • An Approved Indication Per ACC/AHA/HRS Guidelines for Implantation of a Cardiac Resynchronization Therapy Defibrillator
Other: this is an observational study. No intervention
CRT
Patients with implanted cardiac resynchronization therapy defibrillator
Intervention: Other: this is an observational study. No intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
400
Not Provided
December 2021   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • an approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D

Exclusion Criteria:

  • age < 18 y
  • pregnancy or planned pregnancy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01924221
RER CRT, NA_00065477
No
Larisa Tereshchenko, Johns Hopkins University
Johns Hopkins University
Not Provided
Not Provided
Johns Hopkins University
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP