Septal - Success Rate and Clinical Outcome of Septal Implant of Ventricular Defibrillation Lead
Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00180297
Collaborator
Guidant Corporation (Industry)
215
18
2
89
11.9
0.1
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the safety and efficacy of the implant of a ICD lead of defibrillation in the septum of the right ventricle
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The rate of success at implant and the positive clinical outcomes for the patients implanted with a lead of defibrillation at the septal site would make it possible to recommend this site as a "new standard" for implant of the defibrillation lead in the RV for ICD.
Study Design
Study Type:
Interventional
Actual Enrollment
:
215 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Evaluation of the Success Rate and the Clinical Evolution of a Ventricular Lead Implanted in the Septum Versus the Right Ventricular Apex.
Study Start Date
:
Apr 1, 2005
Actual Primary Completion Date
:
Sep 1, 2012
Actual Study Completion Date
:
Sep 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mid septal site location RV lead is placed at mid septum. |
Device: Endotak Reliance G
Reliance G is a defibrillation lead to be placed in the right ventricle.
|
| Active Comparator: Apical site location RV lead is placed in apical position |
Device: Endotak Reliance G
Reliance G is a defibrillation lead to be placed in the right ventricle.
|
Outcome Measures
Primary Outcome Measures
- Implant Success Rate at Septal Site [At implant]
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.
Secondary Outcome Measures
- - 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 [3 months, 6 months, 12 months, 36 months, 60 months]
in VT zone with at least one efficient ATP
- Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment [Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months]
- Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment [Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months]
- Evolution of Left Ventricular Ejection Fraction [12 Months]
LVEF at 12 months and the change in LVEF at 12 months compared to implant (in %)
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- ICD indication according to current Guidelines
Exclusion Criteria:
- Indication for cardiac resynchronisation therapy, absence of spontaneous ventricular rhythm, pacemaker dependency
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CH Amiens | Amiens | France | 80054 | |
| 2 | CHU Angers | Angers | France | 49033 | |
| 3 | CH Besancon | Besancon | France | 25030 | |
| 4 | CHU Clermont Ferrand | Clermont Ferrand | France | 63003 | |
| 5 | CHU Henri Mandor | Créteil | France | 94010 | |
| 6 | CHU Michalon | Grenoble | France | 38043 | |
| 7 | CH St. Joseph | Marseille | France | 13008 | |
| 8 | CHU La Timone | Marseille | France | 13385 | |
| 9 | CHU Montpellier | Montpellier | France | 34295 | |
| 10 | CHU Nantes | Nantes | France | 34295 | |
| 11 | Nouvelle Clinique Nantaise | Nantes | France | 34295 | |
| 12 | CHU Lariboisière | Paris | France | 75010 | |
| 13 | CHU Pitié Salpitrière | Paris | France | 75013 | |
| 14 | HEGP | Paris | France | 75908 | |
| 15 | Hôpital Pontchaillou | Rennes | France | ||
| 16 | CHU Rouen | Rouen | France | 76031 | |
| 17 | CHU Rangueil | Toulouse | France | 31403 | |
| 18 | CHU Tours | Tours | France | 37044 |
Sponsors and Collaborators
- Boston Scientific Corporation
- Guidant Corporation
Investigators
- Principal Investigator: Philippe Mabo, MD, Hôpital Pontchaillou, Rennes, France
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00180297
Other Study ID Numbers:
- Septal 1.1 / 14.04.2005
- 2004/12/012
First Posted:
Sep 16, 2005
Last Update Posted:
Oct 14, 2021
Last Verified:
Sep 1, 2012
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Mid Septal Site Location | Apical Site Location |
|---|---|---|
| Arm/Group Description | RV lead is placed at mid septum. Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle. | RV lead is placed in apical position Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle. |
| Period Title: Overall Study | ||
| STARTED | 107 | 108 |
| COMPLETED | 61 | 67 |
| NOT COMPLETED | 46 | 41 |
Baseline Characteristics
| Arm/Group Title | Mid Septal Site Location | Apical Site Location | Total |
|---|---|---|---|
| Arm/Group Description | RV lead is placed at mid septum. Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle. | RV lead is placed in apical position Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle. | Total of all reporting groups |
| Overall Participants | 107 | 108 | 215 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
60.3
(12)
|
59.1
(12.7)
|
59.7
(12.4)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
16
15%
|
18
16.7%
|
34
15.8%
|
| Male |
91
85%
|
90
83.3%
|
181
84.2%
|
Outcome Measures
| Title | Implant Success Rate at Septal Site |
|---|---|
| Description | 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. |
| Time Frame | At implant |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Mid Septal Site Location | Apical Site Location |
|---|---|---|
| Arm/Group Description | RV lead is placed at mid septum. Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle. | RV lead is placed in apical position Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle. |
| Measure Participants | 107 | 108 |
| Count of Participants [Participants] |
97
90.7%
|
99
91.7%
|
| Title | - The Number of "Low Energy" Shocks (at 11 Joules), Efficient in the VT Zone, in the Population Programmed at This Recommended Value. |
|---|---|
| Description | |
| Time Frame | 3 months, 6 months, 12 months, 36 months, 60 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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 |
| Arm/Group Title | Mid Septal Site Location | Apical Site Location |
|---|---|---|
| Arm/Group Description | RV lead is placed at mid septum. Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle. | RV lead is placed in apical position Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle. |
| Measure Participants | 91 | 104 |
| 3 Months |
0
0%
|
3
2.8%
|
| 6 Months |
1
0.9%
|
4
3.7%
|
| 12 Months |
2
1.9%
|
7
6.5%
|
| 36 Months |
2
1.9%
|
11
10.2%
|
| 60 Months |
4
3.7%
|
9
8.3%
|
| Title | The Rate of ATP Success Therapy |
|---|---|
| Description | in VT zone with at least one efficient ATP |
| Time Frame | 3 months, 6 months, 12 months, 36 months, 60 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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 |
| Arm/Group Title | Mid Septal Site Location | Apical Site Location |
|---|---|---|
| Arm/Group Description | RV lead is placed at mid septum. Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle. | RV lead is placed in apical position Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle. |
| Measure Participants | 91 | 104 |
| 3 Months |
6
5.6%
|
11
10.2%
|
| 6 Months |
12
11.2%
|
14
13%
|
| 12 Months |
19
17.8%
|
19
17.6%
|
| 36 Months |
23
21.5%
|
23
21.3%
|
| 60 Months |
17
15.9%
|
20
18.5%
|
| Title | Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment |
|---|---|
| Description | |
| Time Frame | Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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 |
| Arm/Group Title | Mid Septal Site Location | Apical Site Location |
|---|---|---|
| Arm/Group Description | RV lead is placed at mid septum. Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle. | RV lead is placed in apical position Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle. |
| Measure Participants | 107 | 108 |
| Discharge |
1
0.9%
|
2
1.9%
|
| 3 Months |
8
7.5%
|
11
10.2%
|
| 6 Months |
14
13.1%
|
17
15.7%
|
| 12 Months |
21
19.6%
|
22
20.4%
|
| 36 Months |
23
21.5%
|
28
25.9%
|
| 60 Months |
19
17.8%
|
23
21.3%
|
| Title | Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment |
|---|---|
| Description | |
| Time Frame | Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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 |
| Arm/Group Title | Mid Septal Site Location | Apical Site Location |
|---|---|---|
| Arm/Group Description | RV lead is placed at mid septum. Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle. | RV lead is placed in apical position Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle. |
| Measure Participants | 107 | 108 |
| Discharge |
0
0%
|
0
0%
|
| 3 Months |
4
3.7%
|
3
2.8%
|
| 6 Months |
3
2.8%
|
4
3.7%
|
| 12 Months |
9
8.4%
|
8
7.4%
|
| 36 Months |
8
7.5%
|
6
5.6%
|
| 60 Months |
8
7.5%
|
5
4.6%
|
| Title | Evolution of Left Ventricular Ejection Fraction |
|---|---|
| Description | LVEF at 12 months and the change in LVEF at 12 months compared to implant (in %) |
| Time Frame | 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Mid Septal Site Location | Apical Site Location |
|---|---|---|
| Arm/Group Description | RV lead is placed at mid septum. Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle. | RV lead is placed in apical position Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle. |
| Measure Participants | 82 | 99 |
| LVEF at 12 Months |
41.96
(13.81)
|
40.57
(14.00)
|
| LVEF (%) Change from Implant |
5.66
(11.96)
|
6.16
(11.96)
|
Adverse Events
| Time Frame | 5 years after device implant | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Mid Septal Site Location | Apical Site Location | ||
| Arm/Group Description | RV lead is placed at mid septum. Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle. | RV lead is placed in apical position Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle. | ||
All Cause Mortality |
||||
| Mid Septal Site Location | Apical Site Location | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 20/107 (18.7%) | 27/108 (25%) | ||
Serious Adverse Events |
||||
| Mid Septal Site Location | Apical Site Location | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 35/107 (32.7%) | 34/108 (31.5%) | ||
| Cardiac disorders | ||||
| Ablation | 2/107 (1.9%) | 3 | 0/108 (0%) | 0 |
| Atrial Fibrillation | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Angina Pectoris | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Angioplasty | 4/107 (3.7%) | 4 | 0/108 (0%) | 0 |
| Arrhythmic Storm | 5/107 (4.7%) | 7 | 3/108 (2.8%) | 3 |
| Bypass | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Cardioversion | 2/107 (1.9%) | 2 | 3/108 (2.8%) | 3 |
| Cardiac Resynchronization Therapy - Defibrillator | 1/107 (0.9%) | 1 | 1/108 (0.9%) | 1 |
| Defibrillation thhreshold | 1/107 (0.9%) | 1 | 2/108 (1.9%) | 2 |
| Drug | 6/107 (5.6%) | 8 | 5/108 (4.6%) | 5 |
| Effusion | 1/107 (0.9%) | 1 | 0/108 (0%) | 0 |
| Explant Intracardiac defibrillator | 1/107 (0.9%) | 1 | 0/108 (0%) | 0 |
| Explant System | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Ventricular Fibrillation | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Heart Transplant | 4/107 (3.7%) | 4 | 3/108 (2.8%) | 3 |
| heart Failure | 5/107 (4.7%) | 9 | 13/108 (12%) | 16 |
| Intracardiac Defibrillator Programming | 1/107 (0.9%) | 1 | 0/108 (0%) | 0 |
| Left Ventricular assistance | 1/107 (0.9%) | 1 | 0/108 (0%) | 0 |
| Mitral Valve | 1/107 (0.9%) | 1 | 0/108 (0%) | 0 |
| Orthostatic | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Pain | 2/107 (1.9%) | 3 | 0/108 (0%) | 0 |
| Peripheral angioplasty | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Pre-transplant | 0/107 (0%) | 0 | 3/108 (2.8%) | 3 |
| reprogramming | 1/107 (0.9%) | 1 | 0/108 (0%) | 0 |
| Ventricular Tachycardia | 1/107 (0.9%) | 1 | 2/108 (1.9%) | 2 |
| Endocrine disorders | ||||
| Diabetes | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Hypoglycemie | 1/107 (0.9%) | 1 | 0/108 (0%) | 0 |
| Thyroid | 1/107 (0.9%) | 2 | 0/108 (0%) | 0 |
| Eye disorders | ||||
| Eye | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Gastrointestinal disorders | ||||
| Abdominal | 2/107 (1.9%) | 2 | 0/108 (0%) | 0 |
| General disorders | ||||
| Dental | 1/107 (0.9%) | 1 | 0/108 (0%) | 0 |
| 0/107 (0%) | 0 | 1/108 (0.9%) | 1 | |
| Hepatobiliary disorders | ||||
| Cholesystectomy | 1/107 (0.9%) | 1 | 0/108 (0%) | 0 |
| Infections and infestations | ||||
| Artheritis | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Gout | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Hematoma/Infection | 2/107 (1.9%) | 4 | 1/108 (0.9%) | 1 |
| Infection | 2/107 (1.9%) | 2 | 4/108 (3.7%) | 4 |
| Pocket infection | 1/107 (0.9%) | 1 | 0/108 (0%) | 0 |
| Rhumatism | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Hematoma/infection at implant | 1/107 (0.9%) | 1 | 2/108 (1.9%) | 2 |
| Investigations | ||||
| Other | 1/107 (0.9%) | 1 | 0/108 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Orthopedic | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Bladder Cancer | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Cancer | 0/107 (0%) | 0 | 1/108 (0.9%) | 2 |
| Nervous system disorders | ||||
| Neurologic | 1/107 (0.9%) | 1 | 2/108 (1.9%) | 2 |
| Vagal syndrome | 1/107 (0.9%) | 1 | 0/108 (0%) | 0 |
| Product Issues | ||||
| Connection | 1/107 (0.9%) | 1 | 0/108 (0%) | 0 |
| Dislodgement | 2/107 (1.9%) | 2 | 1/108 (0.9%) | 1 |
| End of life | 3/107 (2.8%) | 3 | 4/108 (3.7%) | 4 |
| Failure | 1/107 (0.9%) | 1 | 1/108 (0.9%) | 1 |
| Oversensing | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| premature End of Life | 3/107 (2.8%) | 3 | 3/108 (2.8%) | 3 |
| Psychiatric disorders | ||||
| Antivitamin K Overdose | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Renal and urinary disorders | ||||
| renal angioplasty | 0/107 (0%) | 0 | 1/108 (0.9%) | 2 |
| Renal insufficiency | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| urogenital | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Reproductive system and breast disorders | ||||
| prostate | 1/107 (0.9%) | 1 | 1/108 (0.9%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Pleural effusion | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Pneumopathy | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Pneumothorax | 1/107 (0.9%) | 1 | 0/108 (0%) | 0 |
| Pulmonary | 2/107 (1.9%) | 4 | 0/108 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| scar dehiscence | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Surgical and medical procedures | ||||
| post sternotomy | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Vascular disorders | ||||
| Aneurysm | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Aorto Femoro Bypass | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Bleeding | 1/107 (0.9%) | 1 | 0/108 (0%) | 0 |
| Carotid | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Cardiovascular Accident (CVA) | 0/107 (0%) | 0 | 2/108 (1.9%) | 2 |
Other (Not Including Serious) Adverse Events |
||||
| Mid Septal Site Location | Apical Site Location | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 17/107 (15.9%) | 17/108 (15.7%) | ||
| Cardiac disorders | ||||
| Atrial Fibrillation | 1/107 (0.9%) | 1 | 1/108 (0.9%) | 1 |
| Angor | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Atrial Disorder | 1/107 (0.9%) | 1 | 0/108 (0%) | 0 |
| Heart Failure | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Shock | 1/107 (0.9%) | 1 | 0/108 (0%) | 0 |
| Tricuspid insufficiency | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Supraventricular Tachycardia | 1/107 (0.9%) | 1 | 2/108 (1.9%) | 2 |
| Endocrine disorders | ||||
| Thyroid | 1/107 (0.9%) | 1 | 0/108 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Dysphagy | 1/107 (0.9%) | 1 | 0/108 (0%) | 0 |
| General disorders | ||||
| Pain | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Implant | 2/107 (1.9%) | 2 | 0/108 (0%) | 0 |
| Sternotomy wires | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Metabolism and nutrition disorders | ||||
| diet | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Tumor | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Nervous system disorders | ||||
| Neurologic | 0/107 (0%) | 0 | 1/108 (0.9%) | 2 |
| Product Issues | ||||
| Crosstalk | 1/107 (0.9%) | 1 | 0/108 (0%) | 0 |
| Impedance > 3000 | 1/107 (0.9%) | 1 | 0/108 (0%) | 0 |
| Inappropriate Therapy | 1/107 (0.9%) | 1 | 2/108 (1.9%) | 4 |
| Limit algorhythm | 2/107 (1.9%) | 3 | 4/108 (3.7%) | 4 |
| Loss Capture | 1/107 (0.9%) | 1 | 1/108 (0.9%) | 1 |
| Oversensing | 0/107 (0%) | 0 | 2/108 (1.9%) | 2 |
| Rhythm ID | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Smart sensing | 0/107 (0%) | 0 | 1/108 (0.9%) | 1 |
| Inappropriate programming | 4/107 (3.7%) | 5 | 3/108 (2.8%) | 3 |
| Psychiatric disorders | ||||
| Psychologic | 1/107 (0.9%) | 1 | 0/108 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Site of puncture | 1/107 (0.9%) | 1 | 0/108 (0%) | 0 |
| Surgical and medical procedures | ||||
| healing issue | 1/107 (0.9%) | 1 | 0/108 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Elisabeth Mouton - Clinical Trial Manager |
|---|---|
| Organization | Boston Scientific |
| Phone | +33 1 39 30 11 90 |
| elisabeth.mouton@bsci.com |
Responsible Party:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00180297
Other Study ID Numbers:
- Septal 1.1 / 14.04.2005
- 2004/12/012
First Posted:
Sep 16, 2005
Last Update Posted:
Oct 14, 2021
Last Verified:
Sep 1, 2012