Atrial FibrillationAMPNCT06669637
Amplify EP Registry
An observational study of Atrial Fibrillation, run by Heart Rhythm Clinical and Research Solutions, LLC.
Trial summary
An observational, prospective, multi-center, non-randomized registry designed to obtain real world clinical experience with the TactiFlex Catheter Ablation system in the treatment of Atrial Fibrillation. Patient assessments will occur at pre procedure and procedure, and 1 year post ablation Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Ablation
- Type of treatment
- Medical device
- How many people
- 1,100 participants
- Where
- No sites listed yet
- Study dates
- 22 Nov 2024to Dec 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
Study population: Participants with atrial fibrillation undergoing ablation at selected sites who meet eligibility. Site in US, Canda, and OUS
Who may be able to join
- Patients who, in the opinion of the investigator, are candidates for ablation to treat atrial fibrillation.
- Plans to undergo an ablation procedure using the TactiFlex Ablation Catheter™, Sensor Enabled™ (TactiFlex SE) manufactured by Abbott.
- De Novo or redo AF catheter ablation procedures.
- Able and willing to participate in baseline and all follow up evaluations.
- 18 years of age or older.
Who cannot join
- Enrolled in any other cardiac device clinical trial, investigational drug trial, or any other trial that may confound the results of the ablation procedure.
- In the opinion of the investigator, any known contraindication to an ablation procedure or to any device or drug required for use during an ablation procedure as assessed by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Courtney Muenchow contact
About this study
An observational, prospective, multi-center, non-randomized registry designed to obtain real world clinical experience with the TactiFlex Catheter Ablation system in the treatment of Atrial Fibrillation. Patient assessments will occur at pre procedure and procedure, and 1 year post ablation
- Conditions
- Atrial Fibrillation
- Being tested
- Ablation
- Keywords
- Ablation, Radiofrequency
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationDevice
Ablation procedure for Atrial Fibrillation
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing AF Ablation using TactiFlex catheter | patients undergoing de novo or redo AF ablation procedures using TactiFlex ablation catheter following patients up to 6 to 12 months follow up. Receives: Device: Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term effectiveness
defined as freedom from recurrence of AF/AT/AFL >30 sec at 12-month follow-up
Measured: 12-month
Secondary outcomes (3)
Acute success
ability to obtain pulmonary vein isolation during the ablation using TactiFlex catheter only
Measured: at time of procedure
Acute safety
rate of acute safety events defined as procedure or device related complications that occur within 7 days of the procedure and incidence per-procedural complications that occur greater than 7 days but less than 30 days post ablation
Measured: 30 days
Long term safety
Rate of long-term safety events defined as procedure or device related complications that occur greater than 30 days post ablation.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start22 Nov 2024 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- 1,100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Heart Rhythm Clinical and Research Solutions, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669637
- Sponsor's protocol ID
- Amplify
- Acronym
- AMP
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amplify EP Registry
- ClinicalTrials.gov ID
- NCT06669637
- Acronym / sponsor ID
- AMP / Amplify
- Conditions
- Atrial Fibrillation
- Keywords
- Ablation, Radiofrequency
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Heart Rhythm Clinical and Research Solutions, LLCUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 22 Nov 2024 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Nov 2024 (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.
An observational, prospective, multi-center, non-randomized registry designed to obtain real world clinical experience with the TactiFlex Catheter Ablation system in the treatment of Atrial Fibrillation. Patient assessments will occur at pre procedure and procedure, and 1 year post ablation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing AF Ablation using TactiFlex catheter | – | Device: Ablationpatients undergoing de novo or redo AF ablation procedures using TactiFlex ablation catheter following patients up to 6 to 12 months follow up. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with atrial fibrillation undergoing ablation at selected sites who meet eligibility. Site in US, Canda, and OUS
Key inclusion criteria (5 listed)
- Patients who, in the opinion of the investigator, are candidates for ablation to treat atrial fibrillation.
- Plans to undergo an ablation procedure using the TactiFlex Ablation Catheter™, Sensor Enabled™ (TactiFlex SE) manufactured by Abbott.
- De Novo or redo AF catheter ablation procedures.
- Able and willing to participate in baseline and all follow up evaluations.
- 18 years of age or older.
Key exclusion criteria (2 listed)
- Enrolled in any other cardiac device clinical trial, investigational drug trial, or any other trial that may confound the results of the ablation procedure.
- In the opinion of the investigator, any known contraindication to an ablation procedure or to any device or drug required for use during an ablation procedure as assessed by the investigator.
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 |
|---|---|---|
| AblationAblation procedure for Atrial Fibrillation | Device | Patients undergoing AF Ablation using TactiFlex catheter |
Primary outcome
Long term effectiveness
Time frame: 12-month
defined as freedom from recurrence of AF/AT/AFL >30 sec at 12-month follow-up
3 secondary outcomes
Acute success
Time frame: at time of procedure
Acute safety
Time frame: 30 days
Long term safety
Time frame: 12 months
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 1 Nov 2024.
- 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.
Courtney Muenchow contact
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Heart Rhythm Clinical and Research Solutions, LLC.
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 5 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: opening soon, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Kim Harbin (256-591-0727, kharbin@hrcrs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long term effectiveness (time frame: 12-month). 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 1 Nov 2024.