Restoration of Chronotropic Competence in Heart Failure Patients With Normal Ejection Fraction (RESET)
This study will look at how pacing your heart may assist your daily activities and how you are feeling.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Restoration of Chronotropic Competence in Heart Failure Patients With Normal Ejection Fraction|
- Peak VO2 [ Time Frame: 1 month, 6 months ] [ Designated as safety issue: No ]
- Quality of Life [ Time Frame: 1 month, 6 months, 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Two experimental and/or intervention groups under 1 arm.
Device: Insignia Plus / Ultra (Guidant/Boston Scientific)
Cardiac pacing using any Guidant/Boston Scientific Implantable Pacemaker System with rate-modulation and any compatible intracardiac lead system.
Other Name: Guidant or Boston Scientific implantable pacemakers
RESET is a multicenter trial that will assess the effect of pacing in heart failure patients with a normal ejection fraction (or diastolic heart failure). The purpose of the RESET study is to evaluate the effect of pacing on exercise capacity and quality of life in this heart failure population.
|United States, Arkansas|
|Cardiovascular Associates of Northeast Arkansas|
|Jonesboro, Arkansas, United States, 72401|
|United States, Kentucky|
|Louisville, Kentucky, United States, 40205|
|United States, Maryland|
|Johns Hopkins Medical Institutions|
|Baltimore, Maryland, United States, 21205|
|United States, Minnesota|
|Mayo Clinic Foundation|
|Rochester, Minnesota, United States, 55902|
|United States, Texas|
|Tyler CV Consultants - Trinity Mother Frances|
|Tyler, Texas, United States, 75701|
|Principal Investigator:||David A Kass, M.D.||Johns Hopkins Medical Institutions|