Right Ventricular Defibrillation Lead Select Site Study

Status Recruiting

Clinical Trial Summary

This study will compare single coil right ventricular defibrillation leads for implanted cardioverter/defibrillators (ICDs) in the apical and high septal locations. It is hypothesized that RV septal positions are at least as good as apical positions using formally measured defibrillation thresholds(DFTs), and that they may have long term advantages in reducing left ventricular dysfunction.

Clinical Trial Description

The new studies "Right Ventricular Lead/Select Site Registry" and "Right Ventricular Lead/Select Site Registry: Acute Study" are studies designed to look at alternate lead locations for defibrillation leads for ICDs. The registry is designed to capture data from patients who have already undergone implant, so as to be able to publish long term data on defibrillation thresholds, pacing thresholds and left ventricular function. This will include both patients from the acute study, and those patients in whom leads have already been placed, and the exact lead location is known. The acute study is designed to directly compare defibrillation thresholds in the apical location versus the interventricular septal location for defibrillation leads. This study involves a direct comparison of two different sites in the same patient; using defined criteria for implant location (see protocol). The acute study is anticipated to enroll 34 patients, but the registry to collect ongoing data will be larger, encompassing previously implanted patients, with an expected sample size of 61 total in the registry for data collection. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00385749
Study type	Interventional
Source	Associates in Cardiology, PA
Contact	Michael A Lincoln, MD
Phone	301-681-5700
Email	mlincoln@associatesincardiology.com
Status	Recruiting
Phase	N/A
Start date	October 2006
Completion date	December 2008

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01357850` - A Multi-center, Placebo-controlled Study to Evaluate the Safety of GSK716155 and Its Effects on Myocardial Metabolism, Myocardial Function, and Exercise Capacity in Patients With NYHA Class II/III Congestive Heart Failure	Phase 2
Recruiting	`NCT00532688` - N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure	Phase 2/Phase 3
Terminated	`NCT00383630` - Bone Marrow Cell Transplantation to Improve Heart Function in Individuals With End-Stage Heart Failure	Phase 2
Completed	`NCT00531661` - CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients	N/A
Completed	`NCT00241761` - Epidemiology of Depression and Heart Failure in Aging	N/A
Completed	`NCT00159614` - Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With CHF and Renal Impairment	Phase 2
Terminated	`NCT00125437` - Larger Dose of Spironolactone for the Treatment of Patients With Nonischemic Cardiomyopathy	N/A
Completed	`NCT00149435` - Cardiovascular Health Study (CHS) Events Follow-up Study
Completed	`NCT00094263` - Long-Term Predictors of Morbidity in Older Age	N/A
Completed	`NCT00202579` - Efficacy and Safety of Ivabradine in Severe Congestive Heart Failure	Phase 2
Terminated	`NCT00357591` - Randomized Trial for Patients With Chronic Heart Failure With Acute Decompensation	N/A
Completed	`NCT00048425` - Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure.	Phase 3
Completed	`NCT00023556` - Genetic Architecture of Heart Disease in Rural Brazil	N/A
Completed	`NCT00530426` - Heart Failure Registry	Phase 4
Terminated	`NCT00190359` - Growth Hormone and Heart Failure	N/A
Completed	`NCT00004562` - Occluded Artery Trial (OAT)	Phase 3
Completed	`NCT00005265` - Natural History of Coronary Heart Disease	N/A
Completed	`NCT02772068` - Hemodynamic Response to Exercise in HFpEF Patients After Upregulation of SERCA2a	Early Phase 1
Completed	`NCT02925546` - A Phase I Study to Assess the Pharmacokinetics of GSK2798745 Tablets	Phase 1
Completed	`NCT01074307` - A Prospective, Open-labeled, Multi-centric Trial in Subjects With Systolic Heart Failure to Evaluate Bisoprolol Treatment for the Effects on Surrogate Markers of Heart Failure in Korea	Phase 4