Implantable Cardioverter-DefibrillatorsT-DEFNCT04206371
Defibrillation Testing During Implantable Cardioverter Defibrillator (ICD) Replacement
A study testing Defibrillator threshold testing in people with Implantable Cardioverter-Defibrillators, run by CMC Ambroise Paré at 7 sites in France.
Trial summary
This study will evaluate safety and clinical outcomes of a systematic defibrillation threshold testing in patient with indication for defibrillator replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Implantable Cardioverter-Defibrillators
- What is being tested?
- Defibrillator threshold testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 7 sitesFrance
- Study dates
- 3 Feb 2020to 27 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with an ICD (VR or DR) or CRT-D undergoing generator replacement.
- Consent for participation
- Affiliation to the French social security system
Who cannot join
- Atrial Fibrillation without effective anti-coagulation treatments.
- Severe Aortic valve stenosis
- Stroke occurred in the previous month
- Hemodynamic instability contraindicating the high energy shock
- Contraindication for anesthesia
- Pregnant or breastfeeding women
- Communication difficulties or neuropsychiatric disorder
- Patients under protection of the adults (guardianship, curators or safeguard of justice)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Centre Hospitalier Henri Duffaut
Avignon, Provence-Alpes-Côte d'Azur Region, 84902
CHU de Caen
Caen, Normandy, 14000
Hôpital Trousseau
Chambray-lès-Tours, Centre-Val de Loire, 37170
Hôpital Privé du Confluent
Nantes, Pays de la Loire Region, 44277
CMC Ambroise Paré
Neuilly-sur-Seine, Île-de-France Region, 92200
CHU de Toulouse-Hôpital Rangueil
Toulouse, Occitanie, 31400
Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu-CHU de Nancy-Hôpitaux de Brabois
Vandœuvre-lès-Nancy, Grand Est, 54500
About this study
Official title: Longitudinal Follow-up of Patients With Defibrillator Threshold Testing During Implantable Cardioverter Defibrillator (ICD) Replacement
This study will evaluate safety and clinical outcomes of a systematic defibrillation threshold testing in patient with indication for defibrillator replacement.
Read the detailed description
Implantable cardioverter defibrillators (ICD) are strongly recommended in patients with left ventricular systolic function ≤35% or selected patients with channelopathies and cardiomyopathies.
Defibrillation threshold testing (DFT) defines the minimal energy required to successfully terminate a ventricular arrhythmia by an ICD. It remains the gold standard to evaluate the electrical integrity of the device. However inherent complications of this procedure have been registered, such as refractory ventricular fibrillation, and the need for this practice during implant and/or replacement of ICD has recently been questioned.
If several studies have led to abandonment of the DFT during initial ICD implant, its interest during replacement is still controversial. Indeed, the leads essential for the device electrical integrity are older, more fragile, and the ICD replacement may damage it.
Device replacement is indicated when battery reaches the point of Elective Replacement Interval (ERI).
Patients over 18 years old with indication for replacement of defibrillator will be included. Patient's informations (comorbidities, medical history and events during hospitalization or follow-up) and device characteristics will be collected. Procedure will be realized under local or general anesthesia and prophylactic antibiotic will be administrated. Leads will be tested before and after the implantation of the new device. After connexion of the new implanted device to the leads a DFT will be performed. Protocol of DFT will be decided by the physician who will chose between induction of ventricular fibrillation or R-wave synchronized shock. Patients will be followed for 6 and 12 months from the date of defibrillator replacement.
- Conditions
- Implantable Cardioverter-Defibrillators
- Being tested
- Defibrillator threshold testing
- Keywords
- Defibrillation threshold testing, Defibrillation lead, Defibrillator replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Defibrillator threshold testingDiagnostic test
Under general or local anesthesia. Induction of Ventricular Fibrillation or R-wave synchronized shock
| Study group | Role | What they receive |
|---|---|---|
| Defibrillation testing during ICD replacment | Other | Not described Receives: Diagnostic Test: Defibrillator threshold testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Defibrillator Electrical Integrity Dysfunction During Generator Replacement.
Number of Participants With Abnormal Shock Impedance Value.
Measured: 4 hours
Secondary outcomes (1)
Rate of Lead Malfunction
Number of Participants With Abnormal Shock Impedance Value.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start3 Feb 2020
- Primary completion19 Jan 2022
- Study completion27 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Implantable Cardioverter-DefibrillatorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206371
- Sponsor's protocol ID
- 2019/08
- Acronym
- T-DEF
- Status last verified
- Sep 2023
- First submitted
- 18 Dec 2019
- Last updated
- 3 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Follow-up of Patients With Defibrillator Threshold Testing During Implantable Cardioverter Defibrillator (ICD) Replacement
- ClinicalTrials.gov ID
- NCT04206371
- Acronym / sponsor ID
- T-DEF / 2019/08
- Conditions
- Implantable Cardioverter-Defibrillators
- Keywords
- Defibrillation threshold testing, Defibrillation lead, Defibrillator replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 19 Jan 2022 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 20 Dec 2019 (actual)
- Results
- Posted 14 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate safety and clinical outcomes of a systematic defibrillation threshold testing in patient with indication for defibrillator replacement.
Detailed description
Implantable cardioverter defibrillators (ICD) are strongly recommended in patients with left ventricular systolic function ≤35% or selected patients with channelopathies and cardiomyopathies.
Defibrillation threshold testing (DFT) defines the minimal energy required to successfully terminate a ventricular arrhythmia by an ICD. It remains the gold standard to evaluate the electrical integrity of the device. However inherent complications of this procedure have been registered, such as refractory ventricular fibrillation, and the need for this practice during implant and/or replacement of ICD has recently been questioned.
If several studies have led to abandonment of the DFT during initial ICD implant, its interest during replacement is still controversial. Indeed, the leads essential for the device electrical integrity are older, more fragile, and the ICD replacement may damage it.
Device replacement is indicated when battery reaches the point of Elective Replacement Interval (ERI).
Patients over 18 years old with indication for replacement of defibrillator will be included. Patient's informations (comorbidities, medical history and events during hospitalization or follow-up) and device characteristics will be collected. Procedure will be realized under local or general anesthesia and prophylactic antibiotic will be administrated. Leads will be tested before and after the implantation of the new device. After connexion of the new implanted device to the leads a DFT will be performed. Protocol of DFT will be decided by the physician who will chose between induction of ventricular fibrillation or R-wave synchronized shock. Patients will be followed for 6 and 12 months from the date of defibrillator replacement.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Defibrillation testing during ICD replacment | Other | Diagnostic Test: Defibrillator threshold testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with an ICD (VR or DR) or CRT-D undergoing generator replacement.
- Consent for participation
- Affiliation to the French social security system
Key exclusion criteria (8 listed)
- Atrial Fibrillation without effective anti-coagulation treatments.
- Severe Aortic valve stenosis
- Stroke occurred in the previous month
- Hemodynamic instability contraindicating the high energy shock
- Contraindication for anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Defibrillator threshold testingUnder general or local anesthesia. Induction of Ventricular Fibrillation or R-wave synchronized shock | Diagnostic test | Defibrillation testing during ICD replacment |
Primary outcome
Rate of Defibrillator Electrical Integrity Dysfunction During Generator Replacement.
Time frame: 4 hours
Number of Participants With Abnormal Shock Impedance Value.
1 secondary outcome
Rate of Lead Malfunction
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Defibrillator threshold testing in people with Implantable Cardioverter-Defibrillators, run by CMC Ambroise Paré at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Defibrillator Electrical Integrity Dysfunction During Generator Replacement. (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.