BradycardiaNCT04919733
Fluoroscopy Reduction or Elimination in CIED Implants
A study testing Fluoroscopy reduction in people with Bradycardia and Tachycardia, Ventricular, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
CIED implants require different amounts of fluoroscopy; using 3-D mapping systems, these times could be reduced to near zero fluoroscopy. The investigators aim to describe to what extent fluoroscopy times are reduced on a routine basis on CIED implants Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Bradycardia, Tachycardia, Ventricular, Heart Failure
- What is being tested?
- Fluoroscopy reduction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 3 Jan 2020to 3 Mar 2024
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CIED implants
Who cannot join
- Patients with an urgent life-threatening indication requiring an urgent CIED implant.
- Patients with known venous system abnormalities (as venous occlusion or abandoned non-accessible leads).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CHUS Fleurimont
Sherbrooke, Quebec, J1H 5N4
FELIX AYALA PAREDES, MD PhD, +1 819 3461110 ext. 74947, felix.ayala-paredes@usherbrooke.ca
Claude JEAN, RN, +1 819 3461110 ext. 16317, claude.jean.ciussse-chus@ssss.gouv.qc.ca
About this study
CIED implants require different amounts of fluoroscopy; using 3-D mapping systems, these times could be reduced to near zero fluoroscopy. The investigators aim to describe to what extent fluoroscopy times are reduced on a routine basis on CIED implants
Read the detailed description
Patients with either brady arrhythmias, tachyarrhythmias, heart failure or primary prevention of sudden death receive a cardiac implantable electronic device (CIED) as a standard of care based on guideline indications. All implants require X-ray equipment to visualize the advancement and positioning of leads in different heart chambers. To date only anecdotical cases have been reported in the literature, of implants without fluoroscopy, mostly pregnant patients with a CIED indication that could not wait for implant after delivery or some rare situations where ultrasound was used to guide the leads trough the heart.
There are two reported experiences using St-Jude Abbot 3-D NavX system; where 35 (ICD and pacemakers) and 15 (VVI pacemakers only) CIED patients were respectively approached with times reported to right ventricular lead implant of 18 +/- 22 minutes and atrial lead implant of 16 +/- 9 minutes, in 89% of cases a final fluoroscopy shot was deemed necessary (in 16% of patients it was needed to correct final position); in the second report with VVI only pacemakers, the implant of a single lead was 10.1 +/- 5.4 minutes, and the total procedure duration was 59.3 +/- 15.16 minutes -one patient needed fluoroscopy-, this last cohort was compared to previous 15 VVI pacemaker patients implanted under fluoroscopy, with control times of 51.5 +/- 12.3 minutes6 (p=ns); both studies reported around 10 minutes needed to obtain right chamber anatomies. There is a little more experience on biventricular implants with two reports one single center and then the same Italian group with a multicenter study achieving a significant reduction in fluoroscopy times: from 16 minutes to 4 minutes (ranges from 11-26 to 0.3-10.4 minutes) compared with a historical control, and with the same success rates to left lead implants; even in experienced centers (more than 10 previous implants) the median time was 3 minutes of fluoroscopy when a St-Jude Abbot NavX system was used.
The advancement on 3-D mapping systems, allows nowadays to reduce and even eliminate the need of X-rays for most of ablation procedures, where the catheters advancement, positioning and navigation through the four heart chambers is accomplished with minimal or no irradiation to the patients and to the health care personnel.
The hypothesis is that use of standard 3-D mapping systems to achieve CIED implants is feasible, safe, and that could be accomplished in a time efficient way. This will be the first large report for all type of CIED implants and with all available 3-D mapping system utilization; the investigators will try also to define if a complete reconstructed virtual anatomy is needed of if a rough anatomy is sufficient to achieve the implant, and speed procedure times.
- Conditions
- Bradycardia, Tachycardia, Ventricular, Heart Failure
- Being tested
- Fluoroscopy reduction
- Keywords
- CIED implant, Fluoroscopy reduction
- Medical subject headings
- Bradycardia, Tachycardia, Ventricular, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoroscopy reductionDevice
To decrease, using 3-D mapping systems, the amount of fluoroscopy needed to implant a CIED
| Study group | Role | What they receive |
|---|---|---|
| Non fluoroscopy CIED implant | Experimental | Try to reduce as much as possible the fluoroscopy needed to implant a CIED pacemaker or defibrillator using a 3-D mapping system Receives: Device: Fluoroscopy reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluoroscopy time needed to implant a CIED while using 3-D mapping systems to reduce fluoroscopy exposure
Fluoroscopy time while implanting a CIED
Measured: During implant procedure
Peak skin dose of radiation exposure during CIED implant
Radiation exposure expressed as total Cumulative Air Kerma (mGy)
Measured: During implant procedure
Radiation exposure (kerma-area product) during CIED implant
Total Dose Area Product (uGy-m2)
Measured: During implant procedure
Total procedural time
Time of the patient entering the lab, to the time the patient exits the lab
Measured: During implant procedure
Safety issues arising because of reduction of fluoroscopy
Complications arising while using a reduced fluoroscopy environment
Measured: During implant procedure
Secondary outcomes (2)
Detailed 3-D mapping needed Y/N
Is it necessary to create a detailed anatomy to navigate leads without fluoroscopy
Measured: During implant procedure
Current of lesion at desired implant fixation site (Y/N)
If current of lesion is necessary to ascertain that the fixation mechanism is already deployed
Measured: During implant procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start3 Jan 2020
- Primary completion3 Jan 2024 (estimated)
- Study completion3 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies 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
- To ascertain if the use of 3-D mapping systems reduces the need of fluoroscopy during a CIED (pacemaker or defibrillator) implant
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Felix AYALA PAREDES, MD, PhD, Principal investigator, University of Shebrooke Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919733
- Sponsor's protocol ID
- 2019-3060
- Status last verified
- May 2022
- First submitted
- 12 May 2021
- Last updated
- 26 May 2022
- Results posted
- No
- 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 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoroscopy Reduction or Elimination in CIED Implants
- ClinicalTrials.gov ID
- NCT04919733
- Acronym / sponsor ID
- 2019-3060
- Conditions
- Bradycardia, Tachycardia, Ventricular, Heart Failure
- Keywords
- CIED implant, Fluoroscopy reduction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 3 Jan 2024 (estimated)
- Study completion
- 3 Mar 2024 (estimated)
- First posted
- 9 Jun 2021 (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.
CIED implants require different amounts of fluoroscopy; using 3-D mapping systems, these times could be reduced to near zero fluoroscopy. The investigators aim to describe to what extent fluoroscopy times are reduced on a routine basis on CIED implants
Detailed description
Patients with either brady arrhythmias, tachyarrhythmias, heart failure or primary prevention of sudden death receive a cardiac implantable electronic device (CIED) as a standard of care based on guideline indications. All implants require X-ray equipment to visualize the advancement and positioning of leads in different heart chambers. To date only anecdotical cases have been reported in the literature, of implants without fluoroscopy, mostly pregnant patients with a CIED indication that could not wait for implant after delivery or some rare situations where ultrasound was used to guide the leads trough the heart.
There are two reported experiences using St-Jude Abbot 3-D NavX system; where 35 (ICD and pacemakers) and 15 (VVI pacemakers only) CIED patients were respectively approached with times reported to right ventricular lead implant of 18 +/- 22 minutes and atrial lead implant of 16 +/- 9 minutes, in 89% of cases a final fluoroscopy shot was deemed necessary (in 16% of patients it was needed to correct final position); in the second report with VVI only pacemakers, the implant of a single lead was 10.1 +/- 5.4 minutes, and the total procedure duration was 59.3 +/- 15.16 minutes -one patient needed fluoroscopy-, this last cohort was compared to previous 15 VVI pacemaker patients implanted under fluoroscopy, with control times of 51.5 +/- 12.3 minutes6 (p=ns); both studies reported around 10 minutes needed to obtain right chamber anatomies. There is a little more experience on biventricular implants with two reports one single center and then the same Italian group with a multicenter study achieving a significant reduction in fluoroscopy times: from 16 minutes to 4 minutes (ranges from 11-26 to 0.3-10.4 minutes) compared with a historical control, and with the same success rates to left lead implants; even in experienced centers (more than 10 previous implants) the median time was 3 minutes of fluoroscopy when a St-Jude Abbot NavX system was used.
The advancement on 3-D mapping systems, allows nowadays to reduce and even eliminate the need of X-rays for most of ablation procedures, where the catheters advancement, positioning and navigation through the four heart chambers is accomplished with minimal or no irradiation to the patients and to the health care personnel.
The hypothesis is that use of standard 3-D mapping systems to achieve CIED implants is feasible, safe, and that could be accomplished in a time efficient way. This will be the first large report for all type of CIED implants and with all available 3-D mapping system utilization; the investigators will try also to define if a complete reconstructed virtual anatomy is needed of if a rough anatomy is sufficient to achieve the implant, and speed procedure times.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To ascertain if the use of 3-D mapping systems reduces the need of fluoroscopy during a CIED (pacemaker or defibrillator) implant
| Arm | Type | Receives |
|---|---|---|
| Non fluoroscopy CIED implant | Experimental | Device: Fluoroscopy reductionTry to reduce as much as possible the fluoroscopy needed to implant a CIED pacemaker or defibrillator using a 3-D mapping system |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- CIED implants
Key exclusion criteria (2 listed)
- Patients with an urgent life-threatening indication requiring an urgent CIED implant.
- Patients with known venous system abnormalities (as venous occlusion or abandoned non-accessible leads).
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 |
|---|---|---|
| Fluoroscopy reductionTo decrease, using 3-D mapping systems, the amount of fluoroscopy needed to implant a CIED | Device | Non fluoroscopy CIED implant |
Primary outcome
Fluoroscopy time needed to implant a CIED while using 3-D mapping systems to reduce fluoroscopy exposure
Time frame: During implant procedure
Fluoroscopy time while implanting a CIED
Peak skin dose of radiation exposure during CIED implant
Time frame: During implant procedure
Radiation exposure expressed as total Cumulative Air Kerma (mGy)
Radiation exposure (kerma-area product) during CIED implant
Time frame: During implant procedure
Total Dose Area Product (uGy-m2)
Total procedural time
Time frame: During implant procedure
Time of the patient entering the lab, to the time the patient exits the lab
Safety issues arising because of reduction of fluoroscopy
Time frame: During implant procedure
Complications arising while using a reduced fluoroscopy environment
2 secondary outcomes
Detailed 3-D mapping needed Y/N
Time frame: During implant procedure
Current of lesion at desired implant fixation site (Y/N)
Time frame: During implant procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 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.
Felix AYALA PAREDES, MD, PhD principal investigator
University of Shebrooke Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoroscopy reduction in people with Bradycardia and Tachycardia, Ventricular, run by Université de Sherbrooke 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 2 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: status not confirmed, as of the sponsor's last update on 26 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Felix AYALA PAREDES, MD, PhD (819 346 1110 ext. 74947, felix.ayala-paredes@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluoroscopy time needed to implant a CIED while using 3-D mapping systems to reduce fluoroscopy exposure (time frame: During implant procedure). The study lists 5 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 26 May 2022.