Recurrent Ventricular TachycardiaNCT02799693
Intramural Needle Ablation for Ventricular Tachycardia
An observational study of Recurrent Ventricular Tachycardia, run by John Sapp at 1 site in Canada.
Trial summary
This is a single-arm non-randomized prospective observational cohort study to assess the outcomes of patients undergoing intramural needle catheter ablation of recurrent ventricular tachycardia that has failed antiarrhythmic drug therapy and standard radiofrequency (RF) catheter ablation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Recurrent Ventricular Tachycardia
- How many people
- 4 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2016to 30 May 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with recurrent ventricular tachycardia who have failed radiofrequency catheter ablation who are undergoing intramural needle catheter ablation procedures.
Who may be able to join
- Patients undergoing catheter ablation using the needle ablation catheter for ventricular arrhythmias.
Who cannot join
- Patient refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Intramural Needle Ablation for Recurrent Ventricular Tachycardia That Has Failed Conventional Radiofrequency Ablation
This is a single-arm non-randomized prospective observational cohort study to assess the outcomes of patients undergoing intramural needle catheter ablation of recurrent ventricular tachycardia that has failed antiarrhythmic drug therapy and standard radiofrequency (RF) catheter ablation. Following ablation, patients will be monitored for 6 months. The duration of the study is up to 4 years.
Read the detailed description
This is an observational prospective cohort study of patients undergoing needle catheter ablation. Patients with recurrent sustained or incessant ventricular tachycardia who have recurrent monomorphic ventricular tachycardia that has failed antiarrhythmic drug therapy and prior catheter ablation who are undergoing intramural needle ablation for VT will be offered participation. Data will be collected during the procedure and during follow-up. Patients will be monitored in hospital for complications and during 6 months follow-up.
Data Collection:
Baseline Data: Baseline demographic information and a narrative medical history will be collected on all patients, including documentation of prior cardiac history, and arrhythmia history, as well as prior medications and cardiac procedures.
Procedural data: Details of the procedure including both procedural methods and arrhythmias induced, ablation parameters, needle deployments, recordings and response to procedure.
Followup data: Adverse events will be collected for events which are documented during enrollment and follow-up. During follow-up, hospitalizations will be collected, need for further procedures, implantable defibrillator therapies and procedures will be collected, as well as follow-up echocardiography findings.
- Conditions
- Recurrent Ventricular Tachycardia
- Keywords
- Catheter Ablation, Ventricular Tachycardia, Intramural Needle Catheter
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Recurrent VT failing RF ablation | Patients undergoing intramural needle catheter ablation of recurrent monomorphic ventricular tachycardia who have failed prior attempted radiofrequency catheter ablation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from hospitalization for recurrent VT during 6 months following ablation
Control of VT as defined by: freedom from hospitalization for recurrent VT during the 6 months following ablation
Measured: 6 months
Absence of serious adverse events attributable to the procedure which occur within 30 days of the ablation procedure
Absence of all serious adverse events that are potentially procedure related and occur within 30 days of the ablation procedure.
Measured: 6 months
Secondary outcomes (20)
Acute Procedural Success
Termination of at least one clinical or presumptive clinical monomorphic VT by RF ablation or rendering that VT no longer inducible
Measured: 6 hours
Acute procedural complications
Any complications occurring within 24 hours post procedure described as probably or possibly related to the VT catheter ablation procedure
Measured: 24 hours
Number of inducible VT morphologies
Number of VT morphologies induced during catheter ablation
Measured: 6 hours
ICD therapy - shocks
Number of VT events treated with appropriate ICD shocks at 3 months post procedure
Measured: 3 months
ICD therapy - shocks
Number of VT events treated with appropriate ICD shocks at 6 months post procedure
Measured: 6 months
ICD therapy - ATP
Number of VT events treated with antitachycardia pacing (without shock) during 3 months follow-up post-ablation procedure
Measured: 3 months
ICD therapy - ATP
Number of VT events treated with antitachycardia pacing (without shock) during 6 months follow-up post-ablation procedure
Measured: 6 months
ICD Therapy
Number of VT events treated with antitachycardia pacing (with shock) during 3 months follow-up post-ablation procedure
Measured: 3 months
ICD Therapy
Number of VT events treated with antitachycardia pacing (with shock) during 6 months follow-up post-ablation procedure
Measured: 6 months
VT storm
Number of VT storm events during 3 months follow-up
Measured: 3 months
VT storm
Number of VT storm events during 6 months follow-up
Measured: 6 months
VT events
Difference in number of VT events during 3 months prior to and following procedure
Measured: 3 months
VT events
Difference in number of VT events during 6 months prior to and following procedure
Measured: 6 months
Recurrent VT
Time to first recurrent VT
Measured: 6 months
Appropriate ATP
Time to first appropriate ATP
Measured: 6 months
Appropriate ICD shock
Time to first appropriate ICD shock
Measured: 6 months
VT Storm
Time to first VT storm
Measured: 6 months
Antiarrhythmic Drug Therapy
Changes in antiarrhythmic drug therapy post-procedure
Measured: 6 months
Total appropriate ICD shocks
Total number of appropriate ICD shocks during 3 months follow up
Measured: 3 months
Total appropriate ICD shocks
Total number of appropriate ICD shocks during 6 months follow up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startJul 2016
- Primary completion5 Apr 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Ventricular 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Sapp
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John Sapp, Nova Scotia Health Authority
- Investigators
- John Sapp, MD FRCPC, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799693
- Sponsor's protocol ID
- Sapp002
- Status last verified
- Mar 2022
- First submitted
- 2 Jun 2016
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Intramural Needle Ablation for Recurrent Ventricular Tachycardia That Has Failed Conventional Radiofrequency Ablation
- ClinicalTrials.gov ID
- NCT02799693
- Acronym / sponsor ID
- Sapp002
- Conditions
- Recurrent Ventricular Tachycardia
- Keywords
- Catheter Ablation, Ventricular Tachycardia, Intramural Needle Catheter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- John SappUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 5 Apr 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 15 Jun 2016 (estimated)
- 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.
This is a single-arm non-randomized prospective observational cohort study to assess the outcomes of patients undergoing intramural needle catheter ablation of recurrent ventricular tachycardia that has failed antiarrhythmic drug therapy and standard radiofrequency (RF) catheter ablation. Following ablation, patients will be monitored for 6 months. The duration of the study is up to 4 years.
Detailed description
This is an observational prospective cohort study of patients undergoing needle catheter ablation. Patients with recurrent sustained or incessant ventricular tachycardia who have recurrent monomorphic ventricular tachycardia that has failed antiarrhythmic drug therapy and prior catheter ablation who are undergoing intramural needle ablation for VT will be offered participation. Data will be collected during the procedure and during follow-up. Patients will be monitored in hospital for complications and during 6 months follow-up.
Data Collection:
Baseline Data: Baseline demographic information and a narrative medical history will be collected on all patients, including documentation of prior cardiac history, and arrhythmia history, as well as prior medications and cardiac procedures.
Procedural data: Details of the procedure including both procedural methods and arrhythmias induced, ablation parameters, needle deployments, recordings and response to procedure.
Followup data: Adverse events will be collected for events which are documented during enrollment and follow-up. During follow-up, hospitalizations will be collected, need for further procedures, implantable defibrillator therapies and procedures will be collected, as well as follow-up echocardiography findings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recurrent VT failing RF ablation | – | –Patients undergoing intramural needle catheter ablation of recurrent monomorphic ventricular tachycardia who have failed prior attempted radiofrequency catheter ablation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with recurrent ventricular tachycardia who have failed radiofrequency catheter ablation who are undergoing intramural needle catheter ablation procedures.
Key inclusion criteria (1 listed)
- Patients undergoing catheter ablation using the needle ablation catheter for ventricular arrhythmias.
Key exclusion criteria (1 listed)
- Patient refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Freedom from hospitalization for recurrent VT during 6 months following ablation
Time frame: 6 months
Control of VT as defined by: freedom from hospitalization for recurrent VT during the 6 months following ablation
Absence of serious adverse events attributable to the procedure which occur within 30 days of the ablation procedure
Time frame: 6 months
Absence of all serious adverse events that are potentially procedure related and occur within 30 days of the ablation procedure.
20 secondary outcomes
Acute Procedural Success
Time frame: 6 hours
Acute procedural complications
Time frame: 24 hours
Number of inducible VT morphologies
Time frame: 6 hours
ICD therapy - shocks
Time frame: 3 months
ICD therapy - shocks
Time frame: 6 months
ICD therapy - ATP
Time frame: 3 months
ICD therapy - ATP
Time frame: 6 months
ICD Therapy
Time frame: 3 months
ICD Therapy
Time frame: 6 months
VT storm
Time frame: 3 months
VT storm
Time frame: 6 months
VT events
Time frame: 3 months
VT events
Time frame: 6 months
Recurrent VT
Time frame: 6 months
Appropriate ATP
Time frame: 6 months
Appropriate ICD shock
Time frame: 6 months
VT Storm
Time frame: 6 months
Antiarrhythmic Drug Therapy
Time frame: 6 months
Total appropriate ICD shocks
Time frame: 3 months
Total appropriate ICD shocks
Time frame: 6 months
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 15 Mar 2022.
- 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.
John Sapp, MD FRCPC principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Ventricular Tachycardia, run by John Sapp at 1 site in Canada.
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 15 Mar 2022. 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 Canada. 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 hospitalization for recurrent VT during 6 months following ablation (time frame: 6 months). 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 15 Mar 2022.