Trial Outcomes & Findings for Effectiveness of Surgical Mitral Valve Repair Versus Medical Treatment for People With Significant Mitral Regurgitation and Non-ischemic Congestive Heart Failure (NCT NCT00608140)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

2 participants

Primary outcome timeframe

Measured at Month 18

Results posted on

2018-04-04

Participant Flow

Participant milestones

Participant milestones
Measure	1 Medical Therapy Plus Surgery Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement	2 Medical Therapy Only Participants will receive optimal medical therapy alone
Overall Study STARTED	1	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of Surgical Mitral Valve Repair Versus Medical Treatment for People With Significant Mitral Regurgitation and Non-ischemic Congestive Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1 Medical Therapy Plus Surgical Repair n=1 Participants Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement	2 Medical Therapy Only n=1 Participants Participants will receive optimal medical therapy alone	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Age, Continuous	65.5 years n=93 Participants	63 years n=4 Participants	64.25 years STANDARD_DEVIATION 1.49 • n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Sex: Female, Male Male	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment United States	1 participants n=93 Participants	1 participants n=4 Participants	2 participants n=27 Participants

PRIMARY outcome

Timeframe: Measured at Month 18

Population: Data were not analyzed due to study termination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at Month 18

Population: The 2 patients enrolled in the study did not reach their endpoints before the trial was closed. No data were collected for this outcome measure and no analysis was performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at baseline and Month 18 but n/a

Population: The 2 patients enrolled did not meet the 18 month measurement of primary/secondary endpoints before the trial was terminated. No data were collected for this outcome measure and no analysis was performed.

The 2 patients enrolled did not meet the 18 month measurement of primary/secondary endpoints before the trial was terminated. No data were collected for this outcome measure and no analysis was performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Planned to be measured at baseline and Month 18 but n/a

Population: the 2 patients enrolled did not meet the 18 month measurement of primary/secondary endpoints before the trial was terminated. No data were collected for this outcome measure and no analysis was performed.

Change in MLHF score. However, the 2 patients enrolled did not meet the 18 month measurement of primary/secondary endpoints before the trial was terminated. No analysis was performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at baseline and Month 18

Population: The 2 patients enrolled did not meet the 18 month measurement of primary/secondary endpoints before the trial was terminated. No data were collected for this outcome measure and no analysis was performed.

Total days alive and not hospitalized by 18 months. However, the 2 patients enrolled did not meet the 18 month measurement of primary/secondary endpoints before the trial was terminated. No analysis was performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at Month 18

Population: The 2 patients enrolled did not meet the 18 month measurement of primary/secondary endpoints before the trial was terminated. No data were collected for this outcome measure and no analysis was performed.

Total all-cause mortality at 18 months. However, the 2 patients enrolled did not meet the 18 month measurement of primary/secondary endpoints before the trial was terminated. No analysis was performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured between Days 0 and 30 postsurgery

Outcome measures

Outcome measures
Measure	1 Medical Therapy Plus Surgery n=1 Participants Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement	2 Medical Therapy Only n=1 Participants Participants will receive optimal medical therapy alone	Optimal Medical Therapy Plus 18 Month Delayed MVR Participants will receive optimal medical therapy plus 18-month delayed surgical mitral valve repair with complete annular ring placement Surgical mitral valvuloplasty with placement of annular ring (SMVR): Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or significantly elongated chordae as well as significant chordal tethering.
Perioperative Mortality	0 participants	0 participants	—

Adverse Events

1 Medical Therapy Plus Surgery

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

2 Medical Therapy Only

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	1 Medical Therapy Plus Surgery n=1 participants at risk Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement	2 Medical Therapy Only n=1 participants at risk Participants will receive optimal medical therapy alone
Cardiac disorders CARDIAC FAILURE	0.00% 0/1 Adverse events were not collected, only serious adverse events were collected. "0" was entered for Total Number of Participants at Risk where Adverse events were not collected.	100.0% 1/1 • Number of events 1 Adverse events were not collected, only serious adverse events were collected. "0" was entered for Total Number of Participants at Risk where Adverse events were not collected.
Cardiac disorders HAEMODYNAMIC INSTABILITY	0.00% 0/1 Adverse events were not collected, only serious adverse events were collected. "0" was entered for Total Number of Participants at Risk where Adverse events were not collected.	100.0% 1/1 • Number of events 1 Adverse events were not collected, only serious adverse events were collected. "0" was entered for Total Number of Participants at Risk where Adverse events were not collected.
Cardiac disorders ATRIAL FIBRILLATION	100.0% 1/1 • Number of events 1 Adverse events were not collected, only serious adverse events were collected. "0" was entered for Total Number of Participants at Risk where Adverse events were not collected.	0.00% 0/1 Adverse events were not collected, only serious adverse events were collected. "0" was entered for Total Number of Participants at Risk where Adverse events were not collected.

Other adverse events

Adverse event data not reported

Additional Information

Mary Ann Sellers

Duke University

Phone: 919-668-8544

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place