Trial Outcomes & Findings for Assessing Arrhythmias After Ablation Using Implantable Recorders (NCT NCT01176617)
NCT ID: NCT01176617
Last Updated: 2018-04-05
Results Overview
The primary outcome will be arrhythmia recurrences (atrial fibrillation and/or other atrial arrhythmias) after atrial fibrillation ablation over the initial 6 months and one year post-ablation as detected by the implantable loop recorder versus the conventional monitoring strategy. Months 1- 6 patients were being monitored by CM and ILR and in months 6 - 12 they were randomized to either ILR or CM.
COMPLETED
NA
44 participants
6 and 12 months
2018-04-05
Participant Flow
44 patients were enrolled over 4 months; 6 patients withdrew: 4 patients had the device removed before study completion and 2 patients did not return for the required follow-up. The remaining 38 patients completed the study requirements and are reported in the final results.
Participant milestones
| Measure |
Conventional Monitoring Strategy
Subjects will be monitored for 12 months using the conventional strategy which includes wearing a monitor over 3 separate 30-day periods over the first year post-ablation and daily pulse checks.
|
Reveal XT
Subjects will be monitored using the conventional monitoring strategy for the first 6 months post-ablation. During the next 6 months, subjects will be monitored using the data from the Reveal device, transmitted from home every 30 days.
Reveal XT implantable loop recorder: All study participants will receive the Reveal XT implantable loop recorder immediately after completion of the ablation procedure.
|
CM and Reveal XT
This was the non-randomized phase of the study in the first six months of evaluation.
|
|---|---|---|---|
|
1 - 6 Months (Ron-randomized)
STARTED
|
0
|
0
|
38
|
|
1 - 6 Months (Ron-randomized)
COMPLETED
|
0
|
0
|
38
|
|
1 - 6 Months (Ron-randomized)
NOT COMPLETED
|
0
|
0
|
0
|
|
6 - 12 Months (Randomized)
STARTED
|
18
|
20
|
0
|
|
6 - 12 Months (Randomized)
COMPLETED
|
13
|
20
|
0
|
|
6 - 12 Months (Randomized)
NOT COMPLETED
|
5
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Conventional Monitoring Strategy
n=18 Participants
Subjects will be monitored for 12 months using the conventional strategy which includes wearing a monitor over 3 separate 30-day periods over the first year post-ablation and daily pulse checks.
|
Reveal XT
n=20 Participants
Subjects will be monitored using the conventional monitoring strategy for the first 6 months post-ablation. During the next 6 months, subjects will be monitored using the data from the Reveal device, transmitted from home every 30 days.
Reveal XT implantable loop recorder: All study participants will receive the Reveal XT implantable loop recorder immediately after completion of the ablation procedure.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=38 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=18 Participants
|
11 Participants
n=20 Participants
|
22 Participants
n=38 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=18 Participants
|
9 Participants
n=20 Participants
|
16 Participants
n=38 Participants
|
|
Age, Continuous
|
57 Years
STANDARD_DEVIATION 12 • n=18 Participants
|
61 Years
STANDARD_DEVIATION 9 • n=20 Participants
|
59.4 Years
STANDARD_DEVIATION 11 • n=38 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=18 Participants
|
3 Participants
n=20 Participants
|
5 Participants
n=38 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=18 Participants
|
17 Participants
n=20 Participants
|
33 Participants
n=38 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
18 participants
n=18 Participants
|
20 participants
n=20 Participants
|
0 participants
n=38 Participants
|
PRIMARY outcome
Timeframe: 6 and 12 monthsPopulation: Some participants withdrew before completing the full 1 year of required follow-up. In the first 6 months all 38 of the remaining patients arrhythmia recurrence was assessed using CM and Reveal XT. Participants were randomized in this phase to either CM or Reveal XT arms.
The primary outcome will be arrhythmia recurrences (atrial fibrillation and/or other atrial arrhythmias) after atrial fibrillation ablation over the initial 6 months and one year post-ablation as detected by the implantable loop recorder versus the conventional monitoring strategy. Months 1- 6 patients were being monitored by CM and ILR and in months 6 - 12 they were randomized to either ILR or CM.
Outcome measures
| Measure |
Conventional Monitoring Strategy
n=38 Participants
Subjects will be monitored for 12 months using the conventional strategy which includes wearing a monitor over 3 separate 30-day periods over the first year post-ablation and daily pulse checks.
|
Reveal XT
n=38 Participants
Subjects will be monitored using the conventional monitoring strategy for the first 6 months post-ablation. During the next 6 months, subjects will be monitored using the data from the Reveal device, transmitted from home every 30 days.
Reveal XT implantable loop recorder: All study participants will receive the Reveal XT implantable loop recorder immediately after completion of the ablation procedure.
|
Reveal XT and Conventional Monitoring
n=38 Participants
This was the non-randomized phase of the study in the first six months of evaluation.
|
|---|---|---|---|
|
Arrhythmia Burden
First 6 months (non randomized)
|
7 Participants
|
18 Participants
|
18 Participants
|
|
Arrhythmia Burden
6 -12 months (randomized)
|
5 Participants
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Participants were monitored for this end point regardless of the randomization strategy to ensure patient safety.
Change of clinical care include initiation of previously discontinued and/or new anti-arrhythmic drugs, decision for repeat ablation, hospitalization for arrhythmias, discontinuation or reinitiation of atrio-ventricular nodal blocking agents, discontinuation or reinitiation af anticoagulation after ablation and/or decision to implant a pacemaker and/or defibrillator.
Outcome measures
| Measure |
Conventional Monitoring Strategy
n=38 Participants
Subjects will be monitored for 12 months using the conventional strategy which includes wearing a monitor over 3 separate 30-day periods over the first year post-ablation and daily pulse checks.
|
Reveal XT
n=38 Participants
Subjects will be monitored using the conventional monitoring strategy for the first 6 months post-ablation. During the next 6 months, subjects will be monitored using the data from the Reveal device, transmitted from home every 30 days.
Reveal XT implantable loop recorder: All study participants will receive the Reveal XT implantable loop recorder immediately after completion of the ablation procedure.
|
Reveal XT and Conventional Monitoring
This was the non-randomized phase of the study in the first six months of evaluation.
|
|---|---|---|---|
|
Detection of Actionable Events Resulting in Change of Clinical Care
|
0 Participants
|
5 Participants
|
—
|
Adverse Events
Conventional Monitoring Strategy
Reveal XT
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Sanjay Dixit
Hospital of the University of Pennsylvania
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place