Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This post-approval study is designed to provide continued real-world clinical evidence to confirm the safety and long-term effectiveness of atrial fibrillation (AF) radiofrequency (RF) technologies (e.g. TactiCathâ„¢ Contact Force Ablation Catheter, Sensor Enabledâ„¢ (TactiCath SE)) for the treatment of AF.
This post-approval study is a prospective, non-randomized, single arm, multicenter, observational study to evaluate the continued safety and effectiveness of AF RF technologies, including the TactiCath SE. The primary effectiveness endpoint will be the proportion of subjects with freedom from AF recurrence after the initial catheter ablation procedure through 12 months of follow-up (includes a 90-day blanking period). Secondary effectiveness endpoints will be the proportion of subjects with freedom from AF recurrence after the initial catheter ablation procedure through 24 and 36 months of follow-up (includes a 90-day blanking period). The acute primary safety endpoint will be the rate of device and/or procedure-related serious adverse events (SAE) with onset within 7-days of the index ablation procedure utilizing the study catheter. The secondary, long-term safety endpoint will be the rate of device and/or procedure-related SAEs from the index ablation procedure. An independent Clinical Event Committee (CEC) will review all Adverse Device Effects (ADEs) and SAEs and will adjudicate causality relative to the primary safety endpoints.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Single arm group to receive ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electrophysiology study and ablation with an Abbott Ablation Catheter | Device | During the cardiac ablation procedure, an ablation catheter (a thin, flexible tube that can be threaded through the blood vessels to the heart) will deliver radiofrequency energy (a type of heat) to one or more areas in the upper left chamber of the heart that is causing the irregular heartbeat. The tip of the catheter will transmit energy to one or more small spots of heart tissue. This energy creates a small scar on the heart. This scar will block the electrical pathway that is causing the rapid heartbeat |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with freedom from AF recurrence post 90-day blanking period at 12 months | AF recurrence is defined as:
| 12 months |
| Rate of device and/or procedure-related serious adverse events (SAE) with onset within 7-days of the index ablation procedure | Device and/or index procedure-related SAEs are defined below:
| 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| the proportion of subjects with freedom from AF recurrence post 90-day blanking period at 24 months and 36 months | AF recurrence is defined as:
|
Not provided
Inclusion Criteria:
Subject must provide written informed consent prior to any clinical investigation-related procedure.
Documented symptomatic persistent AF, which is defined as continuous AF sustained beyond 7 days and less than 1 year that is documented by a physician's note AND one of the following:
i. that are taken at least 7 days apart but less than 12 months apart. ii. If electrocardiograms are more than 12 months apart, there must be one or more SR recordings in between or within 12 months prior to consent/enrollment NOTE: The most recent ECG must be within 180 days of consent/enrollment. Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of AF from another ECG device.
Subject must have failed, intolerance, or contraindication to a Class I-IV AAD medication.
Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
This clinical investigation will enroll subjects of all genders who have drug refractory, symptomatic, persistent AF.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kristin Ruffner | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center Research, LLC. | Huntsville | Alabama | 35801 | United States | ||
| Arkansas Cardiology |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 36 months |
| the rate of device and/or procedure-related SAEs from the index ablation procedure, descriptively evaluated at 12 months, 24 months, and 36 months | Device and/or index procedure-related SAEs are defined below:
| 36 months |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Eisenhower Medical Center | Rancho Mirage | California | 92270 | United States |
| Sequoia Hospital | Redwood City | California | 94062 | United States |
| Northside Hospital | Atlanta | Georgia | 30342 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Providence Hospital | Southfield | Michigan | 48075 | United States |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | United States |
| St. Patrick Hospital | Missoula | Montana | 59802 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Oklahoma Heart Hospital South | Oklahoma City | Oklahoma | 73135 | United States |
| Doylestown Hospital | Doylestown | Pennsylvania | 18901 | United States |
| Erlanger Medical Center | Chattanooga | Tennessee | 37403 | United States |
| Centennial Medical Center | Nashville | Tennessee | 37203 | United States |
| Methodist Hospital of San Antonio | San Antonio | Texas | 78229 | United States |
| St. Marks Hospital | Salt Lake City | Utah | 84124 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| Chippenham Hospital | Richmond | Virginia | 23225 | United States |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided