Atrial TachycardiaINDUCATHNCT03343860
Catheter Ablation of All Inducible AT Post AF Ablation
A study testing AT case 1.1, AT case 2.1 and AT case 1.2 in people with Atrial Tachycardia and Atrial Fibrillation, run by AZ Sint-Jan AV at 6 sites in 4 countries.
Trial summary
In the treatment of symptomatic drug resistant persistent atrial fibrillation (Ps AF), catheter ablation has a class IIA indication. During the follow-up, a significant amount of patients (~50%) will experience atrial tachycardias (AT) recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Tachycardia, Atrial Fibrillation
- What is being tested?
- AT case 1.1, AT case 2.1 and AT case 1.2
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 5 Apr 2017to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Male or Female Adults (≥18 years old)
- Patients with stable ATPAF at least two months after the first AF ablation procedure.
- Consent signed by the patient after reading the information leaflet
Who cannot join
- Mental or physical inability to take part in the study
- Spontaneous AF in the EP lab
- Presence of any pulmonary vein stents
- Presence of any pre-existing pulmonary vein stenosis
- Presence of any cardiac valve prosthesis
- Clinically significant mitral valve regurgitation or stenosis
Show all 11Show fewer
- Myocardial infarction, PCI / PTCA or coronary artery stenting within the last 3 months
- Unstable angina
- Any cardiac surgery within the last 3 months
- NYHA class III or IV congestive heart failure
- Uncontrolled hyperthyroidism
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
France2 sites
Hôpital Cardiologique d Haut Leveque
Bordeaux, 33304
CHU Toulouse
Toulouse
Germany2 sites
Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz
Mainz
Deutsches Herzzentrum München
Munich, 55131
About this study
Official title: Is Ablation of All Inducible Atrial Tachycardias an Appropriate Endpoint During Redo Procedures After Initial Persistent AF Ablation? A Multi-center, Randomised, Single-blind Study
In the treatment of symptomatic drug resistant persistent atrial fibrillation (Ps AF), catheter ablation has a class IIA indication. During the follow-up, a significant amount of patients (~50%) will experience atrial tachycardias (AT) recurrence. The endpoint of AT ablation during the second procedure has not been validated. At present, several strategies are considered as good clinical practice.
Main objective: To evaluate if ablation of all inducible AT post AF ablation (ATPAFA) offers as substantial benefit in comparison with ablation of the clinical ATPAF only during a redo procedure post initial persistent AF ablation.
Read more
Secondary objectives:
To evaluate the prognosis of non-inducibility during a redo procedure for ATPAFA
- Conditions
- Atrial Tachycardia, Atrial Fibrillation
- Being tested
- AT case 1.1, AT case 2.1, AT case 1.2, AT case 1.3, AT case 1.4
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT case 1.1Procedure or surgery
In the case of AT at the time of ablation :
In the case of sinus rhythm restoration, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Inducibility will be tested but no ablation will be carried out and a DCC post AT mapping will be performed if necessary. The procedure will end up after these steps.
AT case 2.1Procedure or surgery
In the case of AT at the time of ablation :
In the case of sinus rhythm restoration, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Then inducibility will be tested and all inducible AT will be mapped and ablated (max 5 consecutive AT)
AT case 1.2Procedure or surgery
In the case of AT at the time of ablation :
In the case of termination to another AT, a DCC will be performed. Thereafter, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Inducibility will be tested but no ablation will be carried out and a DCC post AT mapping will be performed if necessary. The procedure will end up after these steps.
AT case 1.3Procedure or surgery
In the case of AT at the time of ablation :
In the case of AF deterioration, a DCC will be performed. Thereafter, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Inducibility will be tested but no ablation will be carried out and a DCC post AT mapping will be performed if necessary. The procedure will end up after these steps
AT case 1.4Procedure or surgery
In the case of AT at the time of ablation :
In the case of no AT termination, a DCC will be performed. Thereafter, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Inducibility will be tested but no ablation will be carried out and a DCC post AT mapping will be performed if necessary. The procedure will end up after these steps.
AT case 2.2Procedure or surgery
In the case of AT at the time of ablation :
In the case of termination to another AT, ablation of the subsequent AT will be performed until sinus rhythm restoration. Thereafter, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Then inducibility will be tested and all inducible AT will be mapped and ablated (max 5 consecutive AT)
AT case 2.3Procedure or surgery
In the case of AT at the time of ablation :
In the case of AF deterioration, a DCC will be performed. Thereafter, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Then inducibility will be tested and all inducible AT will be mapped and ablated (max 5 consecutive AT)
AT case 2.4Procedure or surgery
In the case of AT at the time of ablation :
In the case of no AT termination, a DCC will be performed. Thereafter, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Then inducibility will be tested and all inducible AT will be mapped and ablated (max 5 consecutive AT)
SR Case 1Procedure or surgery
In the case of SR at the time of ablation:
PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. The CTI line will be performed in all patients with a ECG showing a typical counterclockwise flutter. Inducibility will be tested but no ablation will be carried out and a DCC post AT mapping will be performed if necessary. The procedure will end up after these steps.
SR Case 2Procedure or surgery
In the case of SR at the time of ablation:
PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. The CTI line will be performed in all patients with a ECG showing a typical counterclockwise flutter. Then inducibility will be tested and all inducible AT will be mapped and ablated (max 10 consecutive AT)
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Active comparator | PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Inducibility will be tested but no ablation will be carried out and a DCC post AT mapping will be performed if necessary. The procedure will end up after these steps. Receives: Procedure: AT case 1.1; Procedure: AT case 1.2; Procedure: AT case 1.3; Procedure: AT case 1.4; Procedure: SR Case 1 |
| Non inducibility | Active comparator | PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Then inducibility will be tested and all inducible AT will be mapped and ablated (max 5 consecutive AT) . Receives: Procedure: AT case 2.1; Procedure: AT case 2.2; Procedure: AT case 2.3; Procedure: AT case 2.4; Procedure: SR Case 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from any documented episode of AT or AF lasting longer than 30 seconds without AAD and occurring during the 1 year follow-up after the ATPAF ablation procedure.
There will be a 1-months blanking period after ATPAF ablation. A repeated left atrial ablation at any time (even during the blanking period) will be considered as a recurrence.
Measured: During 12 months follow-up
Secondary outcomes (6)
The number of non-inducible ATPAFA during a redo procedure
Measured: At repeat procedure(s) during the 12 months follow-up
Incidence of repeat procedures
Measured: During 12 months follow-up
Incidence of procedure related complications
Measured: During 12 months follow-up
Procedure time
Measured: Baseline
Fluoroscopy duration
Measured: Baseline
Correlation of the AT mechanism during the redo procedure with the AT Mechanism during the index procedure
To evaluate the correlation between the ATPAFA mechanism during the index procedure with potential AT mechanism during the follow up (in the case of AT recurrence)
Measured: At repeat procedure(s) during the 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start5 Apr 2017
- Primary completion31 Mar 2021
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial TachycardiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastien Knecht, AZ Sint-Jan AV
- Investigators
- Sebastien Knecht, MD, PhD, Principal investigator, sebastien.knecht@azsintjan.be
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343860
- Sponsor's protocol ID
- 2097
- Acronym
- INDUCATH
- Status last verified
- Aug 2022
- First submitted
- 8 Nov 2017
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Ablation of All Inducible Atrial Tachycardias an Appropriate Endpoint During Redo Procedures After Initial Persistent AF Ablation? A Multi-center, Randomised, Single-blind Study
- ClinicalTrials.gov ID
- NCT03343860
- Acronym / sponsor ID
- INDUCATH / 2097
- Conditions
- Atrial Tachycardia, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the treatment of symptomatic drug resistant persistent atrial fibrillation (Ps AF), catheter ablation has a class IIA indication. During the follow-up, a significant amount of patients (~50%) will experience atrial tachycardias (AT) recurrence. The endpoint of AT ablation during the second procedure has not been validated. At present, several strategies are considered as good clinical practice.
Main objective: To evaluate if ablation of all inducible AT post AF ablation (ATPAFA) offers as substantial benefit in comparison with ablation of the clinical ATPAF only during a redo procedure post initial persistent AF ablation.
Secondary objectives:
To evaluate the prognosis of non-inducibility during a redo procedure for ATPAFA
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | Active comparator | Procedure: AT case 1.1, Procedure: AT case 1.2, Procedure: AT case 1.3, Procedure: AT case 1.4, Procedure: SR Case 1PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Inducibility will be tested but no ablation will be carried out and a DCC post AT mapping will be performed if necessary. The procedure will end up after these steps. |
| Non inducibility | Active comparator | Procedure: AT case 2.1, Procedure: AT case 2.2, Procedure: AT case 2.3, Procedure: AT case 2.4, Procedure: SR Case 2PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Then inducibility will be tested and all inducible AT will be mapped and ablated (max 5 consecutive AT) . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or Female Adults (≥18 years old)
- Patients with stable ATPAF at least two months after the first AF ablation procedure.
- Consent signed by the patient after reading the information leaflet
Key exclusion criteria (11 listed)
- Mental or physical inability to take part in the study
- Spontaneous AF in the EP lab
- Presence of any pulmonary vein stents
- Presence of any pre-existing pulmonary vein stenosis
- Presence of any cardiac valve prosthesis
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 |
|---|---|---|
| AT case 1.1In the case of AT at the time of ablation : In the case of sinus rhythm restoration, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Inducibility will be tested but no ablation will be carried out and a DCC post AT mapping will be performed if necessary. The procedure will end up after these steps. | Procedure or surgery | Conventional |
| AT case 2.1In the case of AT at the time of ablation : In the case of sinus rhythm restoration, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Then inducibility will be tested and all inducible AT will be mapped and ablated (max 5 consecutive AT) | Procedure or surgery | Non inducibility |
| AT case 1.2In the case of AT at the time of ablation : In the case of termination to another AT, a DCC will be performed. Thereafter, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Inducibility will be tested but no ablation will be carried out and a DCC post AT mapping will be performed if necessary. The procedure will end up after these steps. | Procedure or surgery | Conventional |
| AT case 1.3In the case of AT at the time of ablation : In the case of AF deterioration, a DCC will be performed. Thereafter, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Inducibility will be tested but no ablation will be carried out and a DCC post AT mapping will be performed if necessary. The procedure will end up after these steps | Procedure or surgery | Conventional |
| AT case 1.4In the case of AT at the time of ablation : In the case of no AT termination, a DCC will be performed. Thereafter, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Inducibility will be tested but no ablation will be carried out and a DCC post AT mapping will be performed if necessary. The procedure will end up after these steps. | Procedure or surgery | Conventional |
| AT case 2.2In the case of AT at the time of ablation : In the case of termination to another AT, ablation of the subsequent AT will be performed until sinus rhythm restoration. Thereafter, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Then inducibility will be tested and all inducible AT will be mapped and ablated (max 5 consecutive AT) | Procedure or surgery | Non inducibility |
| AT case 2.3In the case of AT at the time of ablation : In the case of AF deterioration, a DCC will be performed. Thereafter, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Then inducibility will be tested and all inducible AT will be mapped and ablated (max 5 consecutive AT) | Procedure or surgery | Non inducibility |
| AT case 2.4In the case of AT at the time of ablation : In the case of no AT termination, a DCC will be performed. Thereafter, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Then inducibility will be tested and all inducible AT will be mapped and ablated (max 5 consecutive AT) | Procedure or surgery | Non inducibility |
| SR Case 1In the case of SR at the time of ablation: PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. The CTI line will be performed in all patients with a ECG showing a typical counterclockwise flutter. Inducibility will be tested but no ablation will be carried out and a DCC post AT mapping will be performed if necessary. The procedure will end up after these steps. | Procedure or surgery | Conventional |
| SR Case 2In the case of SR at the time of ablation: PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. The CTI line will be performed in all patients with a ECG showing a typical counterclockwise flutter. Then inducibility will be tested and all inducible AT will be mapped and ablated (max 10 consecutive AT) | Procedure or surgery | Non inducibility |
Primary outcome
Freedom from any documented episode of AT or AF lasting longer than 30 seconds without AAD and occurring during the 1 year follow-up after the ATPAF ablation procedure.
Time frame: During 12 months follow-up
There will be a 1-months blanking period after ATPAF ablation. A repeated left atrial ablation at any time (even during the blanking period) will be considered as a recurrence.
6 secondary outcomes
The number of non-inducible ATPAFA during a redo procedure
Time frame: At repeat procedure(s) during the 12 months follow-up
Incidence of repeat procedures
Time frame: During 12 months follow-up
Incidence of procedure related complications
Time frame: During 12 months follow-up
Procedure time
Time frame: Baseline
Fluoroscopy duration
Time frame: Baseline
Correlation of the AT mechanism during the redo procedure with the AT Mechanism during the index procedure
Time frame: At repeat procedure(s) during the 12 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
Sebastien Knecht, MD, PhD principal investigator
sebastien.knecht@azsintjan.be
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AT case 1.1, AT case 2.1 and AT case 1.2 in people with Atrial Tachycardia and Atrial Fibrillation, run by AZ Sint-Jan AV at 6 sites in 4 countries.
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 11 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 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Germany, Belgium, United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Freedom from any documented episode of AT or AF lasting longer than 30 seconds without AAD and occurring during the 1 year follow-up after the ATPAF ablation procedure. (time frame: During 12 months follow-up). 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 Aug 2022.