Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Decision made to close enrollment in October and close the registry by December 2023
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Abbott | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
DYNAMIC AF is an observational, prospective, multi-center, non-randomized registry designed to obtain real world clinical experience of radiofrequency (RF) ablation for the treatment of paroxysmal (PAF) and persistent (PsAF) atrial fibrillation ablation. Patient assessments will occur at pre- procedure, procedure, 12 weeks, 6 months and 1 year post ablation.
Dynamic AF is a prospective, observational, multi-center, non-randomized registry designed to obtain real world clinical experience associated with the use of Abbott technologies for AF ablation. Future technologies may be included as they become available in the market. The registry population will include patients with symptomatic PAF or PsAF that meet all eligibility criteria, who, in the opinion of the investigator, are candidates for AF ablation.
All patients will be treated with commercially approved catheters and the ablation procedure will be conducted based on the current standard of care. Participation in the registry does not influence treatment decisions. All consecutive patients presenting at the institution considered for an RF ablation procedure for symptomatic PAF or PsAF should be screened by the investigator or designated member of the research team for study eligibility
The primary purpose of this registry is to assess procedural efficiencies as well as long term procedural safety and effectiveness of RF ablation in the treatment of patients with paroxysmal or persistent atrial fibrillation. The registry will utilize real world clinical data obtained from the use of commercially available technologies under the authority of a health care practitioner within a legitimate practitioner-patient relationship.
To support the objective of the registry, both patient information and procedure data will be collected. Patient-related data will be collected at a pre ablation office visit, a 12-week post ablation office visit, interim arrhythmia recurrence monitoring at 6- and 12-month post ablation and a 12-month post ablation office visit. Procedure related data collection will include procedural workflow and acute, mid and late onset procedure or device related complications.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute SOC Sites with Patients with paroxysmal or persistent atrial fibrillation | Patients with symptomatic, refractory or intolerant to at least one Class I or III AAD, paroxysmal atrial fibrillation (AF episode terminating spontaneously within 7 days) or symptomatic, refractory or intolerant to at least one Class I or III AAD, persistent AF (continuous AF sustained beyond 7-days and less than 1-year) who, in the opinion of the investigator, are candidates for ablation for AF. |
| |
| Symptomatic Monitoring SOC Sites with Patients with paroxysmal or persistent atrial fibrillation | Patients with symptomatic, refractory or intolerant to at least one Class I or III AAD, paroxysmal atrial fibrillation (AF episode terminating spontaneously within 7 days) or symptomatic, refractory or intolerant to at least one Class I or III AAD, persistent AF (continuous AF sustained beyond 7-days and less than 1-year) who, in the opinion of the investigator, are candidates for ablation for AF. |
| |
| Full Monitoring SOC Sites with Patients with paroxysmal or persistent atrial fibrillation | Patients with symptomatic, refractory or intolerant to at least one Class I or III AAD, paroxysmal atrial fibrillation (AF episode terminating spontaneously within 7 days) or symptomatic, refractory or intolerant to at least one Class I or III AAD, persistent AF (continuous AF sustained beyond 7-days and less than 1-year) who, in the opinion of the investigator, are candidates for ablation for AF. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter Ablation | Device | Ablation RF technologies manufactured by Abbott. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long term safety | Long term safety is assessed by collection of procedure or device related complications. | 12 months |
| Long term effectiveness (paroxysmal) | Freedom from atrial arrhythmias (atrial fibrillation/atrial flutter/atrial tachycardia) recurrence (documented episodes greater than 30 seconds) at 12-month follow-up. | 12 months |
| Long term effectiveness (persistent) | Freedom from symptomatic atrial arrhythmia (atrial fibrillation/atrial flutter/atrial tachycardia) recurrence (documented episodes greater than 30 seconds) at 12-month follow-up | 12 months |
| Procedural efficiency | Procedure time, ablation time, fluoroscopy time | Immediately after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Acute success | Termination of clinical arrhythmia, defined by termination to sinus rhythm or non-inducibility of clinical arrhythmia after ablation (cardioversion allowed prior to inducibility attempt) | Immediately after procedure |
| Patient-reported Outcome |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients presenting at participating sites for atrial fibrillation ablation that meet all inclusion criteria.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jose Osorio, MD | Grandview Medical Center | Principal Investigator |
| Paul Zei, PhD, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grandview Medical Center | Birmingham | Alabama | 35243 | United States | ||
| Luminis Health Anne Arundel Medical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Assessed with 3 items-- How do you feel now compared to pre-ablation: 1) at rest; 2) during mild exercise; and 3) during rigorous exercise |
| 12 months |
| Acute safety | Assessed by collection of procedure or device related complications that occur within 7 days of the ablation procedure | 7 days |
| Acute safety | Assessed by collection of peri-procedural complications that occur greater than 7 days but within 30 days post ablation. | 30 days |
| Annapolis |
| Maryland |
| 21401 |
| United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Penn Presbyterian Hospital | Philadelphia | Pennsylvania | 19104 | 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
| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided