Tetralogy of FallotNCT05236153
Electroanatomic Interactions Between Transcatheter Pulmonary Valve Prostheses and Anatomic Isthmuses in Repaired Tetralogy of Fallot
A study testing Electroanatomic substrate mapping in people with Tetralogy of Fallot and Ventricular Tachycardia, run by Boston Children's Hospital at 1 site in United States.
Trial summary
Individuals with repaired Tetralogy of Fallot (rTOF) remain at risk for sudden cardiac death from ventricular tachycardia (VT). Transcatheter pulmonary valve replacement (TPVR) indications continue to broaden, yet its capability to reduce the risk of VT and sudden cardiac death remains unknown. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tetralogy of Fallot, Ventricular Tachycardia, Sudden Cardiac Death
- What is being tested?
- Electroanatomic substrate mapping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2022to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of tetralogy of Fallot (TOF) or double outlet right ventricle (DORV)
- Referred for transcatheter pulmonary valve replacement (TPVR) per routine clinical indications
- Weight >=25 kg
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Edward T O'Leary, MD, 617-355-7833, edward.oleary@cardio.chboston.org
About this study
Individuals with repaired Tetralogy of Fallot (rTOF) remain at risk for sudden cardiac death from ventricular tachycardia (VT). Transcatheter pulmonary valve replacement (TPVR) indications continue to broaden, yet its capability to reduce the risk of VT and sudden cardiac death remains unknown. Thus, in a cohort of participants with rTOF who are presenting for TPVR the investigators intend to: (1) quantify and localize right ventricular (RV) isthmuses with abnormal voltage and/or conduction velocity; (2) identify which RV isthmuses are at risk of being "jailed" by TPV prostheses; and (3) explore the feasibility of omnipolar technology to characterize wavefront directionality and differentiate slow conduction from conduction block.
Read the detailed description
Participants will receive general endotracheal anesthesia or conscious sedation provided by cardiac anesthesiology and usual vascular access as per routine clinical care for TPVR. The TPVR procedure will be performed per routine care independent of study participation or study findings.
Participants who elect to participate in this research study will undergo RV activation and voltage mapping using a diagnostic electrophysiology mapping catheter. Prior to the delivery of the valve prosthesis, a 3-dimensional electroanatomic map (EAM) of the RV with simultaneous omnipolar voltage and activation data in sinus rhythm will be created using a high-density multielectrode mapping catheter (8 Fr Advisor HD Grid, Abbott Cardiovascular) and an EAM system (Ensite X, Abbott Cardiovascular). Pre-procedural CCT or CMR imaging will be overlayed on the EAM using the tricuspid valve annulus, pulmonary valve annulus, and proximal coronary sinus as fiducial markers for registration. The plane of the pulmonary valve annulus and/or the existing pulmonary valve prosthesis will be annotated on the EAM, referencing the merged CCT/CMR and fluoroscopic images. Ventricular pacing at physiologic rates (60-120 bpm) may be performed to assist in differentiating slow conduction from conduction block and confirming areas of scar. No programmed ventricular stimulation pacing with the intention to induce ventricular arrhythmias will be performed. No catheter ablation will be performed.
Following the completion of the study protocol, participants will be followed prospectively for 10 years to evaluate for the development of the following outcomes: documented sustained clinical VT, inducible sustained VT or ventricular fibrillation during intracardiac electrophysiology study, placement of a primary or secondary prevention implantable cardioverter defibrillator (ICD), appropriate ICD shock for VT/VF, and/or sudden cardiac arrest/death. Participant medical records will be reviewed annually for the development of these outcomes. Informed research consent for future medical record review and research team contact with the participant or primary cardiologist will be obtained.
- Being tested
- Electroanatomic substrate mapping
- Medical subject headings
- Tetralogy of Fallot, Tachycardia, Ventricular, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroanatomic substrate mappingDiagnostic test
Participants will undergo a sinus rhythm RV substrate map using the HD Grid catheter (Abbott) and the Ensite X electroanatomic mapping system (Abbott) prior to TPVR.
| Study group | Role | What they receive |
|---|---|---|
| RV mapping | Other | Participants will undergo a sinus rhythm electroanatomic RV substrate map prior to TPVR. Receives: Diagnostic Test: Electroanatomic substrate mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jailed anatomical isthmus area
Percent jailing of each anatomical RV isthmus (jailed area / isthmus area x100)
Measured: Immediately after the procedure.
Future arrhythmic event (composite)
Documented sustained VT, inducible sustained VT/VF at a future EP study, appropriate ICD therapy for VT/VF, sudden cardiac arrest
Measured: 10 years
Secondary outcomes (3)
Presence of any jailed anatomical isthmus
>50% of an anatomical isthmus covered by the TPV prosthesis
Measured: Immediately after the procedure.
Number, location, and dimensions of electroanatomically normal isthmuses.
isthmuses with omnipolar voltage >1.5 mV and conduction velocity >0.5 m/sec
Measured: Immediately after the procedure.
Number, location, and dimensions of electroanatomically abnormal isthmuses.
isthmuses with omnipolar voltage <1.5 mV and conduction velocity <0.5 m/sec
Measured: Immediately after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start4 Nov 2022
- Primary completion3 Nov 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tetralogy of FallotStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Edward O'Leary, Boston Children's Hospital
- Investigators
- Edward T O'Leary, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236153
- Sponsor's protocol ID
- IRB-P00038878
- Status last verified
- Feb 2023
- First submitted
- 21 Jan 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroanatomic Interactions Between Transcatheter Pulmonary Valve Prostheses and Anatomic Isthmuses in Repaired Tetralogy of Fallot
- ClinicalTrials.gov ID
- NCT05236153
- Acronym / sponsor ID
- IRB-P00038878
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 3 Nov 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 11 Feb 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.
Individuals with repaired Tetralogy of Fallot (rTOF) remain at risk for sudden cardiac death from ventricular tachycardia (VT). Transcatheter pulmonary valve replacement (TPVR) indications continue to broaden, yet its capability to reduce the risk of VT and sudden cardiac death remains unknown. Thus, in a cohort of participants with rTOF who are presenting for TPVR the investigators intend to: (1) quantify and localize right ventricular (RV) isthmuses with abnormal voltage and/or conduction velocity; (2) identify which RV isthmuses are at risk of being "jailed" by TPV prostheses; and (3) explore the feasibility of omnipolar technology to characterize wavefront directionality and differentiate slow conduction from conduction block.
Detailed description
Participants will receive general endotracheal anesthesia or conscious sedation provided by cardiac anesthesiology and usual vascular access as per routine clinical care for TPVR. The TPVR procedure will be performed per routine care independent of study participation or study findings.
Participants who elect to participate in this research study will undergo RV activation and voltage mapping using a diagnostic electrophysiology mapping catheter. Prior to the delivery of the valve prosthesis, a 3-dimensional electroanatomic map (EAM) of the RV with simultaneous omnipolar voltage and activation data in sinus rhythm will be created using a high-density multielectrode mapping catheter (8 Fr Advisor HD Grid, Abbott Cardiovascular) and an EAM system (Ensite X, Abbott Cardiovascular). Pre-procedural CCT or CMR imaging will be overlayed on the EAM using the tricuspid valve annulus, pulmonary valve annulus, and proximal coronary sinus as fiducial markers for registration. The plane of the pulmonary valve annulus and/or the existing pulmonary valve prosthesis will be annotated on the EAM, referencing the merged CCT/CMR and fluoroscopic images. Ventricular pacing at physiologic rates (60-120 bpm) may be performed to assist in differentiating slow conduction from conduction block and confirming areas of scar. No programmed ventricular stimulation pacing with the intention to induce ventricular arrhythmias will be performed. No catheter ablation will be performed.
Following the completion of the study protocol, participants will be followed prospectively for 10 years to evaluate for the development of the following outcomes: documented sustained clinical VT, inducible sustained VT or ventricular fibrillation during intracardiac electrophysiology study, placement of a primary or secondary prevention implantable cardioverter defibrillator (ICD), appropriate ICD shock for VT/VF, and/or sudden cardiac arrest/death. Participant medical records will be reviewed annually for the development of these outcomes. Informed research consent for future medical record review and research team contact with the participant or primary cardiologist will be obtained.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RV mapping | Other | Diagnostic Test: Electroanatomic substrate mappingParticipants will undergo a sinus rhythm electroanatomic RV substrate map prior to TPVR. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of tetralogy of Fallot (TOF) or double outlet right ventricle (DORV)
- Referred for transcatheter pulmonary valve replacement (TPVR) per routine clinical indications
- Weight >=25 kg
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Electroanatomic substrate mappingParticipants will undergo a sinus rhythm RV substrate map using the HD Grid catheter (Abbott) and the Ensite X electroanatomic mapping system (Abbott) prior to TPVR. | Diagnostic test | RV mapping |
Primary outcome
Jailed anatomical isthmus area
Time frame: Immediately after the procedure.
Percent jailing of each anatomical RV isthmus (jailed area / isthmus area x100)
Future arrhythmic event (composite)
Time frame: 10 years
Documented sustained VT, inducible sustained VT/VF at a future EP study, appropriate ICD therapy for VT/VF, sudden cardiac arrest
3 secondary outcomes
Presence of any jailed anatomical isthmus
Time frame: Immediately after the procedure.
Number, location, and dimensions of electroanatomically normal isthmuses.
Time frame: Immediately after the procedure.
Number, location, and dimensions of electroanatomically abnormal isthmuses.
Time frame: Immediately after the procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- 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.
Edward T O'Leary, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroanatomic substrate mapping in people with Tetralogy of Fallot and Ventricular Tachycardia, run by Boston Children's Hospital at 1 site in United States.
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 0 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: looking for participants now, as of the sponsor's last update on 8 Feb 2023. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edward T O'Leary, MD (617-355-7833, edward.oleary@cardio.chboston.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Jailed anatomical isthmus area (time frame: Immediately after the procedure.). The study lists 2 primary outcomes in all. 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 8 Feb 2023.