UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060394 |
|---|---|
| Receipt number | R000067903 |
| Scientific Title | Efficacy and safety of septal lead implantation using a delivery catheter in implantable-cardiovert defibrillator recipients : A multicenter observational study (SEPTAL NAGOYA study) |
| Date of disclosure of the study information | 2026/01/17 |
| Last modified on | 2026/01/17 23:54:05 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy and safety of septal lead implantation using a delivery catheter in implantable-cardiovert defibrillator recipients : A multicenter observational study (SEPTAL NAGOYA study)
Acronym
SEPTAL NAGOYA study
Scientific Title
Efficacy and safety of septal lead implantation using a delivery catheter in implantable-cardiovert defibrillator recipients : A multicenter observational study (SEPTAL NAGOYA study)
Scientific Title:Acronym
SEPTAL NAGOYA study
Region
| Japan |
Condition
Condition
Ventricular tachycardia, ventricular fibrillation.
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will conduct a multicenter collaborative study to evaluate the safety and efficacy of implanting the Durata ICD lead (Abbott) in the interventricular septum using a delivery catheter-guided approach. The study will assess the imaging-based success rate of septal placement, lead parameters, and defibrillation thresholds. In addition, outcomes will be compared with those of non-septal lead placements. Furthermore, cases in which the same lead was previously implanted using the conventional stylet-delivery technique will serve as a control group, allowing comparative analysis of the proportion of successful septal placements, procedural safety, subsequent clinical management, and long-term prognosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevalence of true septal ICD lead implantation based on an imaging modality.
Key secondary outcomes
Lead parameters (threshold, sensing, and impedance) at six months postoperatively, shock impedance, defibrillation threshold, paced QRS duration, incidence of lead-related complications, antitachycardia pacing and defibrillation success rates for ventricular arrhythmias, occurrence of atrial fibrillation, and all-cause mortality and heart failure hospitalization during two years after implantation.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Defibrillation test during implantation, chest-CT tomography for an evaluation of the lead position after the implantation.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Patients at participating institutions who underwent transvenous implantation of an ICD or CRT-D (cardiac resynchronization therapy defibrillator) using the Abbott Durata ICD lead between January 2020 and the date of study approval, and who either have a prior history of chest CT imaging or newly provided informed consent for additional CT imaging at the time of data access after study approval (retrospective cohort).
- Patients at participating institutions who will undergo ICD or CRT-D implantation using the Abbott Durata ICD lead and have provided informed consent for CT imaging (prospective cohort).
- Newly implanted device cases.
- Patients aged 18 years or older, regardless of sex.
- The type of ICD lead shall be limited to active-fixation (screw-in) leads.
- Patients who have provided written informed consent to participate in this study.
Key exclusion criteria
- Patients who did not provide informed consent to participate in this study.
- Cases in which a tined lead was used.
- Cases in which the implanted ICD lead was not an Abbott Durata ICD lead.
- Patients with a previous history of defibrillation lead implantation, in whom the lead was extracted and subsequently reimplanted.
- Upgrade cases from a conventional pacemaker system.
- Cases in which a subcutaneous defibrillation lead system was used.
- In the retrospective cohort, cases without prior CT imaging or without additional consent for new CT imaging.
- Cases in which the Abbott Durata ICD lead was used, but the ICD or CRT-D pulse generator was manufactured by another company.
- Any other cases deemed inappropriate for inclusion in the study at the discretion of the principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Toyoaki |
| Middle name | |
| Last name | Murohara |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
466-8550
Address
65, Tsurumai, Showa-ku, Nagoya, Aichi
TEL
81-52-744-2148
murohara@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Yanagisawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Advanced Cardiovascular Therapeutics
Zip code
466-8550
Address
65, Tsurumai, Showa-ku, Nagoya, Aichi
TEL
81-52-744-2148
Homepage URL
yanagisawa-sato@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Nagoya University Ethics Committee
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi4668550, Japan.
Tel
81-52-744-2423
ethics@med.nagoya-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
JCHO中京病院 (愛知県）
大垣市民病院 (岐阜県）
藤田医科大学病院 (愛知県）
日本赤十字社愛知医療センター名古屋第二病院 (愛知県）
浜松医科大学附属病院 (静岡県）
安城更生病院 (愛知県）
海南病院 (愛知県）
市立四日市病院 (三重県）
小牧市民病院 (愛知県）
公立陶生病院 (愛知県）
一宮市立市民病院 (愛知県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 17 | Day |
Last modified on
| 2026 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067903
