Supraventricular TachycardiaNCT05531903
High-density Activation Mapping of the Slow Pathwayto Guide Catheter Ablation in Patients With Typical Atrioventricular Nodal Reentrant Tachycardia
A study testing Description of Slow pathway signals to facilitate ablation in people with Supraventricular Tachycardia and Atrioventricular Nodal Re Entrant Tachycardia, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
Atrioventricular nodal reentrant tachycardia (AVNRT) is the most common supraventricular tachycardia inducible during an electrophysiological study. Although ablative therapy proved to be the treatment of choice, little is known about the components of the tachycardia circuit. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Supraventricular Tachycardia, Atrioventricular Nodal Re Entrant Tachycardia
- What is being tested?
- Description of Slow pathway signals to facilitate ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteSpain
- Study dates
- 15 Oct 2022to 1 Sep 2023
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients > 18 yo with AVNRT observed after electrophysiological study
Who cannot join
- Patients < 18 yo
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-density Activation Mapping of the Slow Pathway During Sinus Rhythm: a New and Simple Method to Guide Catheter Ablation in Patients With Typical Atrioventricular Nodal Reentrant Tachycardia
Atrioventricular nodal reentrant tachycardia (AVNRT) is the most common supraventricular tachycardia inducible during an electrophysiological study. Although ablative therapy proved to be the treatment of choice, little is known about the components of the tachycardia circuit. The aim of this study is to detect the presence and patterns of specific electrograms representing slow pathway (SP) potentials and to explore Koch's triangle pattern activation during sinus rhythm and/or atrial extraestimulus with a high-density mapping catheter in an attempt to clarify a fast and safety catheter ablation strategy. We hypothesized that, in patients with dual atrioventricular nodal physiology, during sinus rhythm (SR), high-density mapping (HDM) catheters could identify the SP signals, making possible to delineate small areas of slow conduction associated to abnormal electrograms on Koch's triangle. On a second step, radiofrequency (RF) applications safety guided by the HDM obtained with this method, should interrupt the circuit far from the His region. Finally, SP signals should disappear after the RF procedure when performing a new 3D HDM. A control group of patients without AVN dual physiology should show absence of fragmented/slow conduction zones.
- Being tested
- Description of Slow pathway signals to facilitate ablation
- Medical subject headings
- Tachycardia, Supraventricular, Tachycardia, Atrioventricular Nodal Reentry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Description of Slow pathway signals to facilitate ablationDevice
3D endocardial mapping in order to identify slow pathway signals and abolish or modificate them after radiofrequency ablation
| Study group | Role | What they receive |
|---|---|---|
| Patients with atrioventricular node reentrant tachycardia | Experimental | Patient with documented AVNRT and fragmented/slow conduction zones observed in a 3D high density mapping Receives: Device: Description of Slow pathway signals to facilitate ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of reinduction of AVNRT after abolition of fragmented/slow conduction signals
Number of patients with absence of fragmented/slow conduction signals observed during sinus rhythm or atrial pacing after radiofrequency application
Measured: one day
Secondary outcomes (2)
Absence of AVNRT relapses
Number of patients with absence of relapses after 1 month of the electrophysiological study
Measured: one month
Percentage of patient without AVNRT reinduction after procedure
Percentage of patients without tachycardia induction after radiofrequency applications protocol
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start15 Oct 2022
- Primary completion30 Jul 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Supraventricular 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single group of intervention. A control group with absence of dual AVN phisiology to check lack of abnormal fragmented/slow conduction confluent zones.
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesus Ignacio Jimenez Lopez, Parc de Salut Mar
- Investigators
- Jesús Ignacio Jimenez López, MD, Principal investigator, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531903
- Sponsor's protocol ID
- CEIm 2022/10521
- Status last verified
- Apr 2024
- First submitted
- 28 Aug 2022
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data will be register with RED CAP
Publications
Jimenez-Lopez J, Bazan V, Gonzalez-Matos CE, Di Marco A, Bottoni N, Battista A, Giacoman S, Sanchez-Millan PJ, Lozano JM, Alvarez-Lopez M, Belarte-Tornero LC, Anguera I, Casteigt BJ, Sarrias-Merce A, Weidmann ZM, Alonso-Martin C, Llorca L, Valles-Gras E. Targeting confluent areas of slow conduction and electrogram fragmentation for atrioventricular node re-entrant tachycardia ablation. Europace. 2024 May 2;26(5):euae094. doi: 10.1093/europace/euae094. No abstract available.
PubMed 38606815
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-density Activation Mapping of the Slow Pathway During Sinus Rhythm: a New and Simple Method to Guide Catheter Ablation in Patients With Typical Atrioventricular Nodal Reentrant Tachycardia
- ClinicalTrials.gov ID
- NCT05531903
- Acronym / sponsor ID
- CEIm 2022/10521
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 8 Sep 2022 (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.
Atrioventricular nodal reentrant tachycardia (AVNRT) is the most common supraventricular tachycardia inducible during an electrophysiological study. Although ablative therapy proved to be the treatment of choice, little is known about the components of the tachycardia circuit. The aim of this study is to detect the presence and patterns of specific electrograms representing slow pathway (SP) potentials and to explore Koch's triangle pattern activation during sinus rhythm and/or atrial extraestimulus with a high-density mapping catheter in an attempt to clarify a fast and safety catheter ablation strategy. We hypothesized that, in patients with dual atrioventricular nodal physiology, during sinus rhythm (SR), high-density mapping (HDM) catheters could identify the SP signals, making possible to delineate small areas of slow conduction associated to abnormal electrograms on Koch's triangle. On a second step, radiofrequency (RF) applications safety guided by the HDM obtained with this method, should interrupt the circuit far from the His region. Finally, SP signals should disappear after the RF procedure when performing a new 3D HDM. A control group of patients without AVN dual physiology should show absence of fragmented/slow conduction zones.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group of intervention. A control group with absence of dual AVN phisiology to check lack of abnormal fragmented/slow conduction confluent zones.
| Arm | Type | Receives |
|---|---|---|
| Patients with atrioventricular node reentrant tachycardia | Experimental | Device: Description of Slow pathway signals to facilitate ablationPatient with documented AVNRT and fragmented/slow conduction zones observed in a 3D high density mapping |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients > 18 yo with AVNRT observed after electrophysiological study
Key exclusion criteria (1 listed)
- Patients < 18 yo
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 |
|---|---|---|
| Description of Slow pathway signals to facilitate ablation3D endocardial mapping in order to identify slow pathway signals and abolish or modificate them after radiofrequency ablation | Device | Patients with atrioventricular node reentrant tachycardia |
Primary outcome
Absence of reinduction of AVNRT after abolition of fragmented/slow conduction signals
Time frame: one day
Number of patients with absence of fragmented/slow conduction signals observed during sinus rhythm or atrial pacing after radiofrequency application
2 secondary outcomes
Absence of AVNRT relapses
Time frame: one month
Percentage of patient without AVNRT reinduction after procedure
Time frame: One day
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 12 Apr 2024.
- Derived from this study: PubMed 38606815Jimenez-Lopez J, Bazan V, Gonzalez-Matos CE, Di Marco A, Bottoni N, Battista A, Giacoman S, Sanchez-Millan PJ, Lozano JM, Alvarez-Lopez M, Belarte-Tornero LC, Anguera I, Casteigt BJ, Sarrias-Merce A, Weidmann ZM, Alonso-Martin C, Llorca L, Valles-Gras E. Targeting confluent areas of slow conduction and electrogram fragmentation for atrioventricular node re-entrant tachycardia ablation. Europace. 2024 May 2;26(5):euae094. doi: 10.1093/europace/euae094. No abstract available.
- Individual participant dataSharing planned: No. Data will be register with RED CAP
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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.
Jesús Ignacio Jimenez López, MD principal investigator
Parc de Salut Mar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Description of Slow pathway signals to facilitate ablation in people with Supraventricular Tachycardia and Atrioventricular Nodal Re Entrant Tachycardia, run by Parc de Salut Mar at 1 site in Spain.
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 1 inclusion and 1 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 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Absence of reinduction of AVNRT after abolition of fragmented/slow conduction signals (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05531903, which also lists 1 linked publication.
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 12 Apr 2024.