Trial Outcomes & Findings for Management of Device Detected AT and Impact of Device Treatment Algorithms on Atrial Fibrillation (NCT NCT04172883)
NCT ID: NCT04172883
Last Updated: 2026-02-27
Results Overview
Probability of participants to encounter 'Persistant AF" was analyzed over time. This information is obtained using Kaplan-Meier method. The occurrence of Persistant AF has been studied over time by using Kaplan-Meier technique. Probabilities and their 95% confidence intervals have been obtained at baseline, 6 months, 12 months and 18 months. We are studying the occurrence of Persistant AF based on results obtained from the Kaplan-Meier method.
TERMINATED
NA
79 participants
up to 18 months
2026-02-27
Participant Flow
The study was multicentric and in a hospital setting, patients were selected based on retrospective data . The study recruitment lasted from 1 Oct 2019 till 30 May 2021 even though the LPE was 5 Feb 2021. The recruitment period ended earlier than initially planned (18 months expected) due to the decision to early terminate the study due to Covid impact.
The study was based on Standard of Care practice and all of the pts were previously implanted with the device, so they were enrolled as long as they met the inclusion criteria and Pt was willing to consent . A total of 79 subjects were enrolled, of which 75 were eligible and randomized.
Participant milestones
| Measure |
Control Arm
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the standard device setting or MINERVA setting ( control arm)
|
Treatment Arm
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the reduced sequence programming ( treatment arm)
Treatment arm: All pts are implanted with rATP enabled devices prior to the study start , the only intervention in both arms is switching on rATP and in the treatment arm programming changes done to optimize the rATP sequence delivery of therapy and prevent the patient from going into permanent or persistent AF
|
|---|---|---|
|
Overall Study
NOT COMPLETED
|
38
|
37
|
|
Overall Study
STARTED
|
38
|
37
|
|
Overall Study
COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Control Arm
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the standard device setting or MINERVA setting ( control arm)
|
Treatment Arm
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the reduced sequence programming ( treatment arm)
Treatment arm: All pts are implanted with rATP enabled devices prior to the study start , the only intervention in both arms is switching on rATP and in the treatment arm programming changes done to optimize the rATP sequence delivery of therapy and prevent the patient from going into permanent or persistent AF
|
|---|---|---|
|
Overall Study
Study early termination
|
38
|
37
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control Arm
n=38 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the standard device setting or MINERVA setting ( control arm)
|
Treatment Arm
n=37 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the reduced sequence programming ( treatment arm)
Treatment arm: All pts are implanted with rATP enabled devices prior to the study start , the only intervention in both arms is switching on rATP and in the treatment arm programming changes done to optimize the rATP sequence delivery of therapy and prevent the patient from going into permanent or persistent AF
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72 years
n=38 Participants
|
71 years
n=37 Participants
|
71 years
n=75 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=38 Participants
|
13 Participants
n=37 Participants
|
25 Participants
n=75 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=38 Participants
|
24 Participants
n=37 Participants
|
50 Participants
n=75 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
India
|
38 participants
n=38 Participants
|
37 participants
n=37 Participants
|
75 participants
n=75 Participants
|
|
Weight
|
68.3 kg
n=38 Participants
|
68.9 kg
n=37 Participants
|
68.8 kg
n=75 Participants
|
|
Height
|
166.5 cm
n=38 Participants
|
165.0 cm
n=37 Participants
|
166.0 cm
n=75 Participants
|
|
BMI
|
25.4 kg/m2
n=38 Participants
|
24.7 kg/m2
n=37 Participants
|
25.2 kg/m2
n=75 Participants
|
|
Systolic BP
|
130.0 mmHg
n=38 Participants
|
128.0 mmHg
n=37 Participants
|
130.0 mmHg
n=75 Participants
|
|
Diastolic BP
|
74.5 mmHg
n=38 Participants
|
70.0 mmHg
n=37 Participants
|
71.0 mmHg
n=75 Participants
|
|
Hearth Rate
|
71 beats/min
n=38 Participants
|
74 beats/min
n=37 Participants
|
72 beats/min
n=75 Participants
|
|
cha2ds2-vasc score
score of 0
|
3 Participants
n=38 Participants
|
0 Participants
n=37 Participants
|
3 Participants
n=75 Participants
|
|
cha2ds2-vasc score
score of 1
|
2 Participants
n=38 Participants
|
4 Participants
n=37 Participants
|
6 Participants
n=75 Participants
|
|
cha2ds2-vasc score
score of 2
|
10 Participants
n=38 Participants
|
9 Participants
n=37 Participants
|
19 Participants
n=75 Participants
|
|
cha2ds2-vasc score
score of 3
|
9 Participants
n=38 Participants
|
12 Participants
n=37 Participants
|
21 Participants
n=75 Participants
|
|
cha2ds2-vasc score
score of 4
|
3 Participants
n=38 Participants
|
6 Participants
n=37 Participants
|
9 Participants
n=75 Participants
|
|
cha2ds2-vasc score
missing information
|
11 Participants
n=38 Participants
|
6 Participants
n=37 Participants
|
17 Participants
n=75 Participants
|
PRIMARY outcome
Timeframe: up to 18 monthsPopulation: The study execution was severely impacted by COVID-19 pandemic. Thus, the decision was taken to terminate the study in August 2021. The median clinical follow-up duration for subject was 14.9 months (over at least 24 months expected), but 33.1% of scheduled visits were missed. The median device follow-up duration for subjects was 7.4 months, 2 out of 75 patients had no device interrogations and 16 only had a baseline device interrogation.Persistent AF occurrence obtained using results from KM.
Probability of participants to encounter 'Persistant AF" was analyzed over time. This information is obtained using Kaplan-Meier method. The occurrence of Persistant AF has been studied over time by using Kaplan-Meier technique. Probabilities and their 95% confidence intervals have been obtained at baseline, 6 months, 12 months and 18 months. We are studying the occurrence of Persistant AF based on results obtained from the Kaplan-Meier method.
Outcome measures
| Measure |
Control Arm
n=38 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the standard device setting or MINERVA setting ( control arm)
|
Treatment Arm
n=35 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the reduced sequence programming ( treatment arm)
Treatment arm: All pts are implanted with rATP enabled devices prior to the study start , the only intervention in both arms is switching on rATP and in the treatment arm programming changes done to optimize the rATP sequence delivery of therapy and prevent the patient from going into permanent or persistent AF
|
|---|---|---|
|
Incidence of 'Persistent AF' Over Time
0 months
|
0 percentage probability
Interval 0.0 to 0.0
|
0 percentage probability
Interval 0.0 to 0.0
|
|
Incidence of 'Persistent AF' Over Time
6 months
|
0 percentage probability
Interval 0.0 to 0.0
|
0 percentage probability
Interval 0.0 to 0.0
|
|
Incidence of 'Persistent AF' Over Time
12 months
|
0 percentage probability
Interval 0.0 to 0.0
|
6.7 percentage probability
Interval 1.0 to 38.7
|
|
Incidence of 'Persistent AF' Over Time
18 months
|
0 percentage probability
Interval 0.0 to 0.0
|
6.7 percentage probability
Interval 1.0 to 38.7
|
SECONDARY outcome
Timeframe: up to 18 monthsPopulation: Seven-hundred and fifty-eight (758) subjects were planned to be enrolled, randomized in a 1:1 fashion to either the interventional or control arms. One subject passed away during the study period due to a myocardial infarction 16.5 months after device implant and 3.1 months after randomization.
Probability of participants to encounter 'All-cause death was analyzed over time. This information is obtained using Kaplan-Meier method. The occurrence of All-cause death has been studied over time by using Kaplan-Meier technique. Probabilities and their 95% confidence intervals have been obtained at baseline, 6 months, 12 months and 18 months. We are studying the occurrence of All-cause death based on results obtained from the Kaplan-Meier method.
Outcome measures
| Measure |
Control Arm
n=38 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the standard device setting or MINERVA setting ( control arm)
|
Treatment Arm
n=36 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the reduced sequence programming ( treatment arm)
Treatment arm: All pts are implanted with rATP enabled devices prior to the study start , the only intervention in both arms is switching on rATP and in the treatment arm programming changes done to optimize the rATP sequence delivery of therapy and prevent the patient from going into permanent or persistent AF
|
|---|---|---|
|
Incidence of All-cause Death Over Time
0 months
|
0 percentage probability
Interval 0.0 to 0.0
|
0 percentage probability
Interval 0.0 to 0.0
|
|
Incidence of All-cause Death Over Time
6 months
|
0 percentage probability
Interval 0.0 to 0.0
|
2.8 percentage probability
Interval 0.4 to 18.1
|
|
Incidence of All-cause Death Over Time
12 months
|
0 percentage probability
Interval 0.0 to 0.0
|
2.8 percentage probability
Interval 0.4 to 18.1
|
|
Incidence of All-cause Death Over Time
18 months
|
0 percentage probability
Interval 0.0 to 0.0
|
2.8 percentage probability
Interval 0.4 to 18.1
|
SECONDARY outcome
Timeframe: 18 MonthsPopulation: A large number of scheduled visits (33.1%) and data were missed between both arms
Compare the two atrial ATP Programming arms in terms of clinical endpoints such as cardiovascular hospitalizations (due to Heart Failure (HF), AF or other), as measured by the time to first event and annual rate of such events. No CV related hospitalization events were observed. This information is obtained using the Kaplan-Meier method. The incidence of CV hospitalization has been studied using the Kaplan-Meier technique. Incidence rates and their 95% confidence intervals have been obtained at baseline, 6 months, 12 months and 18 months.'
Outcome measures
| Measure |
Control Arm
n=38 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the standard device setting or MINERVA setting ( control arm)
|
Treatment Arm
n=37 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the reduced sequence programming ( treatment arm)
Treatment arm: All pts are implanted with rATP enabled devices prior to the study start , the only intervention in both arms is switching on rATP and in the treatment arm programming changes done to optimize the rATP sequence delivery of therapy and prevent the patient from going into permanent or persistent AF
|
|---|---|---|
|
Cardiovascular Hospitalization
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Only one hospitalization event was reported. This hospitalization was not classified as HF-related, AF-related, or other CV-related.
Compare the two atrial ATP Programming arms in terms of clinical endpoints such as all cause hospitalizations and its annual rate on the study
Outcome measures
| Measure |
Control Arm
n=38 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the standard device setting or MINERVA setting ( control arm)
|
Treatment Arm
n=37 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the reduced sequence programming ( treatment arm)
Treatment arm: All pts are implanted with rATP enabled devices prior to the study start , the only intervention in both arms is switching on rATP and in the treatment arm programming changes done to optimize the rATP sequence delivery of therapy and prevent the patient from going into permanent or persistent AF
|
|---|---|---|
|
Annual Rate for All-cause Hospitalization
|
0 event/year
Interval 0.0 to 0.0
|
0.025 event/year
Interval 0.014 to 0.045
|
SECONDARY outcome
Timeframe: up to 18 monthsPopulation: A large number of scheduled visits (33.1%) and data were missed between both arms
Probability of participants to encounter AT/AF Burden ≥ 1day was analyzed over time. This information is obtained using Kaplan-Meier method. The occurrence of AT/AF Burden ≥ 1day has been studied over time by using Kaplan-Meier technique. Probabilities and their 95% confidence intervals have been obtained at baseline, 6 months, 12 months and 18 months. We are studying the occurrence of AT/AF Burden ≥ 1day based on results obtained from the Kaplan-Meier method.
Outcome measures
| Measure |
Control Arm
n=38 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the standard device setting or MINERVA setting ( control arm)
|
Treatment Arm
n=35 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the reduced sequence programming ( treatment arm)
Treatment arm: All pts are implanted with rATP enabled devices prior to the study start , the only intervention in both arms is switching on rATP and in the treatment arm programming changes done to optimize the rATP sequence delivery of therapy and prevent the patient from going into permanent or persistent AF
|
|---|---|---|
|
Incidence of AT/AF Burden ≥ 1day Overtime
6 months
|
4.2 percentage probability
Interval 0.6 to 26.1
|
0 percentage probability
Interval 0.0 to 0.0
|
|
Incidence of AT/AF Burden ≥ 1day Overtime
12 months
|
4.2 percentage probability
Interval 0.6 to 26.1
|
6.7 percentage probability
Interval 1.0 to 38.7
|
|
Incidence of AT/AF Burden ≥ 1day Overtime
0 months
|
0 percentage probability
Interval 0.0 to 0.0
|
0 percentage probability
Interval 0.0 to 0.0
|
|
Incidence of AT/AF Burden ≥ 1day Overtime
18 months
|
4.2 percentage probability
Interval 0.6 to 26.1
|
20 percentage probability
Interval 4.9 to 62.7
|
SECONDARY outcome
Timeframe: up to 18 monthsPopulation: A large number of scheduled visits (33.1%) and data were missed between both arms
Probability of participants to encounter AT/AF Burden ≥ 30 days was analyzed over time. This information is obtained using Kaplan-Meier method. The occurrence of 'AT/AF Burden ≥ 30 days has been studied over time by using Kaplan-Meier technique. Probabilities and their 95% confidence intervals have been obtained at baseline, 6 months, 12 months and 18 months. We are studying the occurrence of AT/AF Burden ≥ 30 days based on results obtained from the Kaplan-Meier method.
Outcome measures
| Measure |
Control Arm
n=38 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the standard device setting or MINERVA setting ( control arm)
|
Treatment Arm
n=35 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the reduced sequence programming ( treatment arm)
Treatment arm: All pts are implanted with rATP enabled devices prior to the study start , the only intervention in both arms is switching on rATP and in the treatment arm programming changes done to optimize the rATP sequence delivery of therapy and prevent the patient from going into permanent or persistent AF
|
|---|---|---|
|
Incidence of AT/AF Burden ≥ 30 Days Overtime
0 months
|
0 percentage probability
Interval 0.0 to 0.0
|
0 percentage probability
Interval 0.0 to 0.0
|
|
Incidence of AT/AF Burden ≥ 30 Days Overtime
6 months
|
0 percentage probability
Interval 0.0 to 0.0
|
0 percentage probability
Interval 0.0 to 0.0
|
|
Incidence of AT/AF Burden ≥ 30 Days Overtime
12 months
|
0 percentage probability
Interval 0.0 to 0.0
|
6.7 percentage probability
Interval 1.0 to 38.7
|
|
Incidence of AT/AF Burden ≥ 30 Days Overtime
18 months
|
0 percentage probability
Interval 0.0 to 0.0
|
6.7 percentage probability
Interval 1.0 to 38.7
|
SECONDARY outcome
Timeframe: up to 18 monthsPopulation: A large number of scheduled visits (33.1%) and data were missed between both arms
Probability of participants to encounter AT/AF Burden ≥ 2 days was analyzed over time. This information is obtained using Kaplan-Meier method. The occurrence of AT/AF Burden ≥ 2 days has been studied over time by using Kaplan-Meier technique. Probabilities and their 95% confidence intervals have been obtained at baseline, 6 months, 12 months and 18 months. We are studying the occurrence of AT/AF Burden ≥ 2 days based on results obtained from the Kaplan-Meier method.
Outcome measures
| Measure |
Control Arm
n=38 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the standard device setting or MINERVA setting ( control arm)
|
Treatment Arm
n=35 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the reduced sequence programming ( treatment arm)
Treatment arm: All pts are implanted with rATP enabled devices prior to the study start , the only intervention in both arms is switching on rATP and in the treatment arm programming changes done to optimize the rATP sequence delivery of therapy and prevent the patient from going into permanent or persistent AF
|
|---|---|---|
|
Incidence of AT/AF Burden ≥ 2 Days Overtime
0 months
|
0 percentage probability
Interval 0.0 to 0.0
|
0 percentage probability
Interval 0.0 to 0.0
|
|
Incidence of AT/AF Burden ≥ 2 Days Overtime
18 months
|
4.2 percentage probability
Interval 0.6 to 26.1
|
6.7 percentage probability
Interval 1.0 to 38.7
|
|
Incidence of AT/AF Burden ≥ 2 Days Overtime
6 months
|
4.2 percentage probability
Interval 0.6 to 26.1
|
0 percentage probability
Interval 0.0 to 0.0
|
|
Incidence of AT/AF Burden ≥ 2 Days Overtime
12 months
|
4.2 percentage probability
Interval 0.6 to 26.1
|
6.7 percentage probability
Interval 1.0 to 38.7
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: A large number of scheduled visits (33.1%) and data were missed between both arms.
Compare the two atrial ATP Programming arms in terms of clinical endpoints to assess number of successful and unsuccessful treated AT/AF episodes out of detected episodes by the device .
Outcome measures
| Measure |
Control Arm
n=38 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the standard device setting or MINERVA setting ( control arm)
|
Treatment Arm
n=35 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the reduced sequence programming ( treatment arm)
Treatment arm: All pts are implanted with rATP enabled devices prior to the study start , the only intervention in both arms is switching on rATP and in the treatment arm programming changes done to optimize the rATP sequence delivery of therapy and prevent the patient from going into permanent or persistent AF
|
|---|---|---|
|
Evaluate Number of Successful and Unsuccessful Treated AT/AF Episodes Out of the Detected Episodes
AT/AF Episodes unsuccessfully treated
|
1.5 events
Interval 0.0 to 3.0
|
2 events
Interval 0.0 to 42.0
|
|
Evaluate Number of Successful and Unsuccessful Treated AT/AF Episodes Out of the Detected Episodes
AT/AF Episodes successfully treated
|
0 events
Interval 0.0 to 2.0
|
2 events
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: A large number of scheduled visits (33.1%) and data were missed between both arms
Compare the two ATP programming arms in terms of clinical endpoints to measure the average number of ATP sequences delivered per patient on each arm
Outcome measures
| Measure |
Control Arm
n=38 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the standard device setting or MINERVA setting ( control arm)
|
Treatment Arm
n=37 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the reduced sequence programming ( treatment arm)
Treatment arm: All pts are implanted with rATP enabled devices prior to the study start , the only intervention in both arms is switching on rATP and in the treatment arm programming changes done to optimize the rATP sequence delivery of therapy and prevent the patient from going into permanent or persistent AF
|
|---|---|---|
|
Measure Number of Delivered Therapies Per Episode
|
8.9 Number of ATP Therapies delivered per AF
Interval 0.0 to 99.0
|
13 Number of ATP Therapies delivered per AF
Interval 3.0 to 22.0
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: A large number of scheduled visits (33.1%) and data were missed between both arms
Compare the two ATP programming arms in terms of clinical endpoints to measure the number of ATP sequences delivered on each arm.
Outcome measures
| Measure |
Control Arm
n=38 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the standard device setting or MINERVA setting ( control arm)
|
Treatment Arm
n=35 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the reduced sequence programming ( treatment arm)
Treatment arm: All pts are implanted with rATP enabled devices prior to the study start , the only intervention in both arms is switching on rATP and in the treatment arm programming changes done to optimize the rATP sequence delivery of therapy and prevent the patient from going into permanent or persistent AF
|
|---|---|---|
|
Evaluate the Number of ATP Sequences
|
53 therapies
Interval 0.0 to 100.0
|
56 therapies
Interval 10.0 to 645.0
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: A large number of scheduled visits (33.1%) and data were missed between both arms
compare the two atrial ATP Programming arms in terms of clinical endpoints to calculate number of stroke, TIA or other thromboembolic events reported on the study across both arms
Outcome measures
| Measure |
Control Arm
n=38 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the standard device setting or MINERVA setting ( control arm)
|
Treatment Arm
n=37 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the reduced sequence programming ( treatment arm)
Treatment arm: All pts are implanted with rATP enabled devices prior to the study start , the only intervention in both arms is switching on rATP and in the treatment arm programming changes done to optimize the rATP sequence delivery of therapy and prevent the patient from going into permanent or persistent AF
|
|---|---|---|
|
Evaluate Number of Stroke, TIA (Transient Ischemic Attack ) or Other Thromboembolic Events
|
0 events
Interval 0.0 to 0.0
|
0 events
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: A large number of scheduled visits (33.1%) and data were missed between both arms. antithrombotic agents.
Compare the two ATP programming arms in terms of clinical endpoints to evaluate the percentage of patients treated with anticoagulation therapy according to AF management guideline.
Outcome measures
| Measure |
Control Arm
n=38 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the standard device setting or MINERVA setting ( control arm)
|
Treatment Arm
n=37 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the reduced sequence programming ( treatment arm)
Treatment arm: All pts are implanted with rATP enabled devices prior to the study start , the only intervention in both arms is switching on rATP and in the treatment arm programming changes done to optimize the rATP sequence delivery of therapy and prevent the patient from going into permanent or persistent AF
|
|---|---|---|
|
Percentage of Patients Treated With Anticoagulation Therapy
prior to enrollment
|
20 Participants
|
26 Participants
|
|
Percentage of Patients Treated With Anticoagulation Therapy
during study participation
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: up to 18 monthsPopulation: A large number of scheduled visits (33.1%) and data were missed between both arms
Compare the two ATP programming arms in terms of clinical endpoints to evaluate the Left Atrial diameter (if available) as measured through an Echocardiogram
Outcome measures
| Measure |
Control Arm
n=12 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the standard device setting or MINERVA setting ( control arm)
|
Treatment Arm
n=15 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the reduced sequence programming ( treatment arm)
Treatment arm: All pts are implanted with rATP enabled devices prior to the study start , the only intervention in both arms is switching on rATP and in the treatment arm programming changes done to optimize the rATP sequence delivery of therapy and prevent the patient from going into permanent or persistent AF
|
|---|---|---|
|
Measure the Left Atrial Diameter Size
baseline
|
36.5 mm
Interval 35.0 to 40.0
|
37 mm
Interval 33.0 to 40.0
|
|
Measure the Left Atrial Diameter Size
6 months
|
34 mm
Interval 32.0 to 41.0
|
41.5 mm
Interval 37.0 to 43.0
|
|
Measure the Left Atrial Diameter Size
12 months
|
36 mm
Interval 36.0 to 36.0
|
49 mm
Interval 49.0 to 49.0
|
|
Measure the Left Atrial Diameter Size
18 months
|
34 mm
Interval 34.0 to 34.0
|
—
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: A large number of scheduled visits (33.1%) and data were missed between both arms
Compare the two ATP programming arms in terms of clinical endpoints such as number of electrical or pharmacological cardio-versions measured in terms of time to first event and its annual rate on the study;
Outcome measures
| Measure |
Control Arm
n=38 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the standard device setting or MINERVA setting ( control arm)
|
Treatment Arm
n=37 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the reduced sequence programming ( treatment arm)
Treatment arm: All pts are implanted with rATP enabled devices prior to the study start , the only intervention in both arms is switching on rATP and in the treatment arm programming changes done to optimize the rATP sequence delivery of therapy and prevent the patient from going into permanent or persistent AF
|
|---|---|---|
|
Number of Pharmacological and Electrical Cardio Versions Reported
|
0 events
Interval 0.0 to 0.0
|
0 events
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Of the 75 enrolled patients, only 15 had CRT-D or CRT-P device implanted, of which 10 were assigned to the interventional arm and 5 to the control arm.
Compare the two ATP programming arms in terms of clinical endpoints such as biventricular pacing percentage (in cardiac resynchronization therapy defibrillator (CRT-D) / cardiac resynchronization therapy-Pacemaker (CRT-P) patients)
Outcome measures
| Measure |
Control Arm
n=5 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the standard device setting or MINERVA setting ( control arm)
|
Treatment Arm
n=10 Participants
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the reduced sequence programming ( treatment arm)
Treatment arm: All pts are implanted with rATP enabled devices prior to the study start , the only intervention in both arms is switching on rATP and in the treatment arm programming changes done to optimize the rATP sequence delivery of therapy and prevent the patient from going into permanent or persistent AF
|
|---|---|---|
|
Evaluate the Biventricular Pacing Percentage (Average)
|
97.7 percentage of ventricular pacing
Interval 71.0 to 99.0
|
98 percentage of ventricular pacing
Interval 97.0 to 99.0
|
SECONDARY outcome
Timeframe: 42monthsA cumulative endpoint which includes number of deaths, cardiovascular hospitalizations, stroke, TIA or other thromboembolic events.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 42 monthsTo evaluate the incidence of persistent AF in patients with sick sinus syndrome as compared to the one found in the Minerva trial, and characterize the difference between the European and Indian populations. The unit of measure will be number of pts that had persistent AF on the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 42 monthsTo evaluate the efficacy of atrial ATP therapies as a function of the device type (Pacemakers(IPG),Cardiac defibrillators (ICD),Cardiac resynchronization Therapy (CRT-D, CRT-P), and population characteristics (baseline characteristics, implant indications) in optimizing therapy and evaluating the successful termination of AF events, preventing pts from going into persistent or permanent AF, as measured by no of ATP's delivered by device.
Outcome measures
Outcome data not reported
Adverse Events
Control Arm
Treatment Arm
Serious adverse events
| Measure |
Control Arm
n=38 participants at risk
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the standard device setting or MINERVA setting ( control arm)
|
Treatment Arm
n=37 participants at risk
The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the reduced sequence programming ( treatment arm)
Treatment arm: All pts are implanted with rATP enabled devices prior to the study start , the only intervention in both arms is switching on rATP and in the treatment arm programming changes done to optimize the rATP sequence delivery of therapy and prevent the patient from going into permanent or persistent AF
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/38 • The adverse events were collected up to 18 months after the index procedure. A total of three adverse events (AEs) (two in the interventional arm and one in the control arm) occurred in three subjects. Of the three, only one AE resulted in the hospitalization of the subject., which was not classified as HF-related, AF-related, or other CV-related
As this is a post market interventional study, we will collect all cardiovascular-related Adverse Event, device-related AE and all SAE.Investigator shall report all SAEs, SADEs and USADEs to the Ethics Committee, monitor and Sponsor promptly of their occurrence. For reported deaths, the investigator shall supply any additional information (e.g., autopsy report ).It is recommended for investigator to report all SAEs, SADE, USADEs to EC within 7 working days .
|
2.7%
1/37 • The adverse events were collected up to 18 months after the index procedure. A total of three adverse events (AEs) (two in the interventional arm and one in the control arm) occurred in three subjects. Of the three, only one AE resulted in the hospitalization of the subject., which was not classified as HF-related, AF-related, or other CV-related
As this is a post market interventional study, we will collect all cardiovascular-related Adverse Event, device-related AE and all SAE.Investigator shall report all SAEs, SADEs and USADEs to the Ethics Committee, monitor and Sponsor promptly of their occurrence. For reported deaths, the investigator shall supply any additional information (e.g., autopsy report ).It is recommended for investigator to report all SAEs, SADE, USADEs to EC within 7 working days .
|
|
Product Issues
lead explantation and IPG repositioning
|
2.6%
1/38 • The adverse events were collected up to 18 months after the index procedure. A total of three adverse events (AEs) (two in the interventional arm and one in the control arm) occurred in three subjects. Of the three, only one AE resulted in the hospitalization of the subject., which was not classified as HF-related, AF-related, or other CV-related
As this is a post market interventional study, we will collect all cardiovascular-related Adverse Event, device-related AE and all SAE.Investigator shall report all SAEs, SADEs and USADEs to the Ethics Committee, monitor and Sponsor promptly of their occurrence. For reported deaths, the investigator shall supply any additional information (e.g., autopsy report ).It is recommended for investigator to report all SAEs, SADE, USADEs to EC within 7 working days .
|
0.00%
0/37 • The adverse events were collected up to 18 months after the index procedure. A total of three adverse events (AEs) (two in the interventional arm and one in the control arm) occurred in three subjects. Of the three, only one AE resulted in the hospitalization of the subject., which was not classified as HF-related, AF-related, or other CV-related
As this is a post market interventional study, we will collect all cardiovascular-related Adverse Event, device-related AE and all SAE.Investigator shall report all SAEs, SADEs and USADEs to the Ethics Committee, monitor and Sponsor promptly of their occurrence. For reported deaths, the investigator shall supply any additional information (e.g., autopsy report ).It is recommended for investigator to report all SAEs, SADE, USADEs to EC within 7 working days .
|
|
General disorders
|
0.00%
0/38 • The adverse events were collected up to 18 months after the index procedure. A total of three adverse events (AEs) (two in the interventional arm and one in the control arm) occurred in three subjects. Of the three, only one AE resulted in the hospitalization of the subject., which was not classified as HF-related, AF-related, or other CV-related
As this is a post market interventional study, we will collect all cardiovascular-related Adverse Event, device-related AE and all SAE.Investigator shall report all SAEs, SADEs and USADEs to the Ethics Committee, monitor and Sponsor promptly of their occurrence. For reported deaths, the investigator shall supply any additional information (e.g., autopsy report ).It is recommended for investigator to report all SAEs, SADE, USADEs to EC within 7 working days .
|
2.7%
1/37 • The adverse events were collected up to 18 months after the index procedure. A total of three adverse events (AEs) (two in the interventional arm and one in the control arm) occurred in three subjects. Of the three, only one AE resulted in the hospitalization of the subject., which was not classified as HF-related, AF-related, or other CV-related
As this is a post market interventional study, we will collect all cardiovascular-related Adverse Event, device-related AE and all SAE.Investigator shall report all SAEs, SADEs and USADEs to the Ethics Committee, monitor and Sponsor promptly of their occurrence. For reported deaths, the investigator shall supply any additional information (e.g., autopsy report ).It is recommended for investigator to report all SAEs, SADE, USADEs to EC within 7 working days .
|
Other adverse events
Adverse event data not reported
Additional Information
Dr.Vinay Rajan, Clinical Research Manager
India Medtronic Pvt Ltd
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place