Septal - Success Rate and Clinical Outcome of Septal Impl... | NCT00180297

ID	Type	Description	Link
2004/12/012

Status Module

Name	Class
Guidant Corporation	INDUSTRY

Label	Type	Description	Intervention Names
Mid septal site location	Experimental	RV lead is placed at mid septum.	Device: Endotak Reliance G
Apical site location	Active Comparator	RV lead is placed in apical position	Device: Endotak Reliance G

Name	Type	Description	Arm Group Labels	Other Names
Endotak Reliance G	Device	Reliance G is a defibrillation lead to be placed in the right ventricle.	Apical site location Mid septal site location

Measure	Description	Time Frame
Implant Success Rate at Septal Site	Success of implant procedure: 1. implanted at the randomized site; 2. With electric criteria satisfied: pacing threshold < 1.5V, intrinsic amplitude >3 mV, impedance between 450 and 1800 Ω, shock impedance between 29 and 80 Ω and defibrillation at a maximum of 21J.	At implant

Measure	Description	Time Frame
- The Number of "Low Energy" Shocks (at 11 Joules), Efficient in the VT Zone, in the Population Programmed at This Recommended Value.		3 months, 6 months, 12 months, 36 months, 60 months
The Rate of ATP Success Therapy	in VT zone with at least one efficient ATP

Name	Affiliation	Role
Philippe Mabo, MD	Hôpital Pontchaillou, Rennes, France	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
CH Amiens		Amiens		80054	France
CHU Angers

ID	Title	Description
FG000	Mid Septal Site Location	RV lead is placed at mid septum. Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.
FG001	Apical Site Location

ID	Title	Description
BG000	Mid Septal Site Location	RV lead is placed at mid septum. Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.
BG001	Apical Site Location	RV lead is placed in apical position Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000107 BG001108 BG002215

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Implant Success Rate at Septal Site

Success of implant procedure: 1. implanted at the randomized site; 2. With electric criteria satisfied: pacing threshold < 1.5V, intrinsic amplitude >3 mV, impedance between 450 and 1800 Ω, shock impedance between 29 and 80 Ω and defibrillation at a maximum of 21J.

Posted

Count of Participants

Participants

At implant

ID	Title	Description
OG000	Mid Septal Site Location	RV lead is placed at mid septum. Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.
OG001	Apical Site Location	RV lead is placed in apical position Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.

Units	Counts
Participants	OG000107 OG001108

Title

Denominators

Categories

Title	Measurements
	OG00097 OG00199

Secondary

- The Number of "Low Energy" Shocks (at 11 Joules), Efficient in the VT Zone, in the Population Programmed at This Recommended Value.

The number of participants analyzed per time frame is excluding those participants that have ended the study before the time frame or for whom visit data is missing

Posted

Count of Participants

Participants

3 months, 6 months, 12 months, 36 months, 60 months

ID	Title	Description
OG000	Mid Septal Site Location	RV lead is placed at mid septum. Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.
OG001	Apical Site Location	RV lead is placed in apical position Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.

Units	Counts
Participants	OG000

Secondary

The Rate of ATP Success Therapy

in VT zone with at least one efficient ATP

The number of participants analyzed per time frame is excluding those participants that have ended the study before the time frame or for whom visit data is missing

Posted

Count of Participants

Participants

3 months, 6 months, 12 months, 36 months, 60 months

ID	Title	Description
OG000	Mid Septal Site Location	RV lead is placed at mid septum. Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.
OG001	Apical Site Location	RV lead is placed in apical position Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.

Units	Counts
Participants	OG000

Secondary

Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment

The number of participants analyzed per time frame is excluding those participants that have ended the study before the time frame or for whom visit data is missing

Posted

Count of Participants

Participants

Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months

ID	Title	Description
OG000	Mid Septal Site Location	RV lead is placed at mid septum. Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.
OG001	Apical Site Location	RV lead is placed in apical position Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.

Units	Counts
Participants	OG000

Secondary

Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment

The number of participants analyzed per time frame is excluding those participants that have ended the study before the time frame or for whom visit data is missing

Posted

Count of Participants

Participants

Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months

ID	Title	Description
OG000	Mid Septal Site Location	RV lead is placed at mid septum. Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.
OG001	Apical Site Location	RV lead is placed in apical position Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.

Units	Counts
Participants	OG000

Secondary

Evolution of Left Ventricular Ejection Fraction

LVEF at 12 months and the change in LVEF at 12 months compared to implant (in %)

Posted

Mean

Standard Deviation

Percentage of LVEF

12 Months

ID	Title	Description
OG000	Mid Septal Site Location	RV lead is placed at mid septum. Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.
OG001	Apical Site Location	RV lead is placed in apical position Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Abdominal	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected107 at risk EG0010 events0 affected108 at risk
Ablation	Cardiac disorders	Systematic Assessment	EG0003 events2 affected107 at risk EG0010 events0 affected108 at risk
Atrial Fibrillation	Cardiac disorders	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Aneurysm	Vascular disorders	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Angina Pectoris	Cardiac disorders	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Angioplasty	Cardiac disorders	Systematic Assessment	EG0004 events4 affected107 at risk EG0010 events0 affected108 at risk
Aorto Femoro Bypass	Vascular disorders	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Arrhythmic Storm	Cardiac disorders	Systematic Assessment	EG0007 events5 affected107 at risk EG0013 events3 affected108 at risk
Artheritis	Infections and infestations	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Antivitamin K Overdose	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Bladder Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Bleeding	Vascular disorders	Systematic Assessment	EG0001 events1 affected107 at risk EG0010 events0 affected108 at risk
Bypass	Cardiac disorders	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected107 at risk EG0012 events1 affected108 at risk
Cardioversion	Cardiac disorders	Systematic Assessment	EG0002 events2 affected107 at risk EG0013 events3 affected108 at risk
Carotid	Vascular disorders	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Cholesystectomy	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected107 at risk EG0010 events0 affected108 at risk
Connection	Product Issues	Systematic Assessment	EG0001 events1 affected107 at risk EG0010 events0 affected108 at risk
Cardiac Resynchronization Therapy - Defibrillator	Cardiac disorders	Systematic Assessment	EG0001 events1 affected107 at risk EG0011 events1 affected108 at risk
Cardiovascular Accident (CVA)	Vascular disorders	Systematic Assessment	EG0000 events0 affected107 at risk EG0012 events2 affected108 at risk
Dental	General disorders	Systematic Assessment	EG0001 events1 affected107 at risk EG0010 events0 affected108 at risk
Defibrillation thhreshold	Cardiac disorders	Systematic Assessment	EG0001 events1 affected107 at risk EG0012 events2 affected108 at risk
Diabetes	Endocrine disorders	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Dislodgement	Product Issues	Systematic Assessment	EG0002 events2 affected107 at risk EG0011 events1 affected108 at risk
Drug	Cardiac disorders	Systematic Assessment	EG0008 events6 affected107 at risk EG0015 events5 affected108 at risk
Effusion	Cardiac disorders	Systematic Assessment	EG0001 events1 affected107 at risk EG0010 events0 affected108 at risk
End of life	Product Issues	Systematic Assessment	EG0003 events3 affected107 at risk EG0014 events4 affected108 at risk
Explant Intracardiac defibrillator	Cardiac disorders	Systematic Assessment	EG0001 events1 affected107 at risk EG0010 events0 affected108 at risk
Explant System	Cardiac disorders	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Eye	Eye disorders	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Failure	Product Issues	Systematic Assessment	EG0001 events1 affected107 at risk EG0011 events1 affected108 at risk
Ventricular Fibrillation	Cardiac disorders	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Gout	Infections and infestations	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Heart Transplant	Cardiac disorders	Systematic Assessment	EG0004 events4 affected107 at risk EG0013 events3 affected108 at risk
Hematoma/Infection	Infections and infestations	Systematic Assessment	EG0004 events2 affected107 at risk EG0011 events1 affected108 at risk
Hematoma/infection at implant	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected107 at risk EG0012 events2 affected108 at risk
heart Failure	Cardiac disorders	Systematic Assessment	EG0009 events5 affected107 at risk EG00116 events13 affected108 at risk
Hypoglycemie	Endocrine disorders	Systematic Assessment	EG0001 events1 affected107 at risk EG0010 events0 affected108 at risk
Intracardiac Defibrillator Programming	Cardiac disorders	Systematic Assessment	EG0001 events1 affected107 at risk EG0010 events0 affected108 at risk
Infection	Infections and infestations	Systematic Assessment	EG0002 events2 affected107 at risk EG0014 events4 affected108 at risk
Left Ventricular assistance	Cardiac disorders	Systematic Assessment	EG0001 events1 affected107 at risk EG0010 events0 affected108 at risk
Mitral Valve	Cardiac disorders	Systematic Assessment	EG0001 events1 affected107 at risk EG0010 events0 affected108 at risk
Neurologic	Nervous system disorders	Systematic Assessment	EG0001 events1 affected107 at risk EG0012 events2 affected108 at risk
Orthopedic	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Orthostatic	Cardiac disorders	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Other	Investigations	Systematic Assessment	EG0001 events1 affected107 at risk EG0010 events0 affected108 at risk
Oversensing	Product Issues	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Pain	Cardiac disorders	Systematic Assessment	EG0003 events2 affected107 at risk EG0010 events0 affected108 at risk
Peripheral angioplasty	Cardiac disorders	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Pneumopathy	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected107 at risk EG0010 events0 affected108 at risk
Pocket infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected107 at risk EG0010 events0 affected108 at risk
post sternotomy	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Pre-transplant	Cardiac disorders	Systematic Assessment	EG0000 events0 affected107 at risk EG0013 events3 affected108 at risk
premature End of Life	Product Issues	Systematic Assessment	EG0003 events3 affected107 at risk EG0013 events3 affected108 at risk
prostate	Reproductive system and breast disorders	Systematic Assessment	EG0001 events1 affected107 at risk EG0011 events1 affected108 at risk
Pulmonary	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0004 events2 affected107 at risk EG0010 events0 affected108 at risk
renal angioplasty	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected107 at risk EG0012 events1 affected108 at risk
Renal insufficiency	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
reprogramming	Cardiac disorders	Systematic Assessment	EG0001 events1 affected107 at risk EG0010 events0 affected108 at risk
Rhumatism	Infections and infestations	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
scar dehiscence	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Thyroid	Endocrine disorders	Systematic Assessment	EG0002 events1 affected107 at risk EG0010 events0 affected108 at risk
	General disorders	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
urogenital	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Vagal syndrome	Nervous system disorders	Systematic Assessment	EG0001 events1 affected107 at risk EG0010 events0 affected108 at risk
Ventricular Tachycardia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected107 at risk EG0012 events2 affected108 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Atrial Fibrillation	Cardiac disorders	Systematic Assessment	EG0001 events1 affected107 at risk EG0011 events1 affected108 at risk
Angor	Cardiac disorders	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Atrial Disorder	Cardiac disorders	Systematic Assessment	EG0001 events1 affected107 at risk EG0010 events0 affected108 at risk
Crosstalk	Product Issues	Systematic Assessment	EG0001 events1 affected107 at risk EG0010 events0 affected108 at risk
diet	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Dysphagy	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected107 at risk EG0010 events0 affected108 at risk
healing issue	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected107 at risk EG0010 events0 affected108 at risk
Heart Failure	Cardiac disorders	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Impedance > 3000	Product Issues	Systematic Assessment	EG0001 events1 affected107 at risk EG0010 events0 affected108 at risk
Implant	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected107 at risk EG0010 events0 affected108 at risk
Inappropriate Therapy	Product Issues	Systematic Assessment	EG0001 events1 affected107 at risk EG0014 events2 affected108 at risk
Limit algorhythm	Product Issues	Systematic Assessment	EG0003 events2 affected107 at risk EG0014 events4 affected108 at risk
Loss Capture	Product Issues	Systematic Assessment	EG0001 events1 affected107 at risk EG0011 events1 affected108 at risk
Neurologic	Nervous system disorders	Systematic Assessment	EG0000 events0 affected107 at risk EG0012 events1 affected108 at risk
Oversensing	Product Issues	Systematic Assessment	EG0000 events0 affected107 at risk EG0012 events2 affected108 at risk
Pain	General disorders	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Psychologic	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected107 at risk EG0010 events0 affected108 at risk
Rhythm ID	Product Issues	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Shock	Cardiac disorders	Systematic Assessment	EG0001 events1 affected107 at risk EG0010 events0 affected108 at risk
Site of puncture	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected107 at risk EG0010 events0 affected108 at risk
Smart sensing	Product Issues	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Sternotomy wires	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Thyroid	Endocrine disorders	Systematic Assessment	EG0001 events1 affected107 at risk EG0010 events0 affected108 at risk
Tricuspid insufficiency	Cardiac disorders	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Supraventricular Tachycardia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected107 at risk EG0012 events2 affected108 at risk
Tumor	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected107 at risk EG0011 events1 affected108 at risk
Inappropriate programming	Product Issues	Systematic Assessment	EG0005 events4 affected107 at risk EG0013 events3 affected108 at risk

ID	Term
D013610	Tachycardia
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D000075224	Cardiac Conduction System Disease
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Mid Septal Site Location	RV lead is placed at mid septum. Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.	20	107	35	107	17	107
EG001	Apical Site Location	RV lead is placed in apical position Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.	27	108	34	108	17	108

ID	Term
D017180	Tachycardia, Ventricular
D014693	Ventricular Fibrillation