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The objective of this clinical study is to demonstrate that ablation with the TactiFlex SE Ablation catheter, in conjunction with a compatible pulsed field ablation (PFA) and/or radio frequency (RF) generator, is safe and effective for the treatment of symptomatic, recurrent, drug refractory paroxysmal atrial fibrillation (PAF).
This is a pre-market, prospective, single-arm, non-randomized, multicenter clinical study to demonstrate safety and effectiveness for the treatment of symptomatic, recurrent, drug-refractory PAF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TactiFlex Ablation catheter | Experimental | A single use catheter that is designed to facilitate electrophysiological mapping of the heart chambers and to transmit RF current or PFA therapy to the catheter's flexible tip electrode for intracardiac ablation purposes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PFA Ablation catheter | Device | Deliver RF and/or PF energy using the TactFlex PFA system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects experiencing a device and/or procedure-related serious adverse event with onset within 7 days of any ablation procedure (index or repeat procedure performed 0-90 days post initial procedure). | 7 days | |
| Freedom from documented (symptomatic or asymptomatic) AF/AFL/AT episodes of greater than 30 seconds duration that are documented by protocol-specified 12-lead ECG, TTM or Holter monitor (HM) devices after the index ablation procedure | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic Effectiveness | Freedom from documented symptomatic AF/AF/AT episodes of greater than 30 seconds duration that are documented by protocol-specific 12-lead ECG, TTM or Holter monitor devices after the index ablation procedure. | 12 months |
| AAD-Free Effectiveness |
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Inclusion Criteria:
Documented symptomatic paroxysmal atrial fibrillation (PAF). Documentation requirements are as follows:
NOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of continuous AF from another ECG device.
Plans to undergo a catheter ablation procedure due to symptomatic PAF and is refractory, intolerant, or contraindicated to at least one Class I-IV AAD medication
At least 18 years of age
Able and willing to comply with all trial requirements including pre- procedure, post-procedure, and follow-up testing and requirements
Informed of the nature of the trial, agreed to its provisions, and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical trial site.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Kammer | Abbott Medical Devices | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth | Scottsdale | Arizona | 85258 | United States | ||
| Arkansas Heart Hospital |
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Freedom from documented (symptomatic or asymptomatic) AF/AFL/AT episodes of > 30 seconds duration that are documented by protocol-specific 12-lead ECG, TTM, or Holter monitor after the index ablation procedure. Any use of Class I or III antiarrythmic drugs after the 90-day blanking period will count as a therapy failure in the analysis |
| 12 months |
| Little Rock |
| Arkansas |
| 72211 |
| United States |
| Stanford University Medical Center | Stanford | California | 94305 | United States |
| South Denver Cardiology Associates PC | Littleton | Colorado | 80120 | United States |
| HCA Florida Mercy Hospital | Miami | Florida | 33133 | United States |
| AdventHealth Orlando | Orlando | Florida | 32803 | United States |
| Tallahassee Research Institute | Tallahassee | Florida | 32308 | United States |
| Piedmont Athens Regional Medical Center | Athens | Georgia | 30606 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Kansas City Cardiac Arrhythmia Research Foundation | Overland Park | Kansas | 66211 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48104 | United States |
| Henry Ford Providence Southfield Hospital | Southfield | Michigan | 48075 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| The Heart Rhythm Center of MS | Gulfport | Mississippi | 39501 | United States |
| Bryan Heart Medical Center | Lincoln | Nebraska | 68506 | United States |
| NYU Langone Health | New York | New York | 10016 | United States |
| New York Presbyterian Hospital/Cornell University | New York | New York | 10021 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Tristar Centennial Medical Center | Nashville | Tennessee | 37203 | United States |
| Vanderbilt Heart & Vascular Institute | Nashville | Tennessee | 37232 | United States |
| Texas Cardiac Arrhythmia | Austin | Texas | 78705 | United States |
| Ocelot Medical Research Group | Dallas | Texas | 75230 | United States |
| Medical City Fort Worth | Fort Worth | Texas | 76104 | United States |
| Houston Methodist The Woodlands Hospital | Shenandoah | Texas | 77385 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23219 | United States |
| The Heart Institute at Virginia Mason | Seattle | Washington | 98111 | United States |
| KH Wiener Neustadt | Wiener Neustadt | L Austr | 2700 | Austria |
| Vilnius University Hospital Santariskiu Klinikos | Vilnius | Dzukija | 08661 | Lithuania |
| Erasmus Medical Center - Thoraxcenter | Rotterdam | S Holln | 3015 CE | Netherlands |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
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